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Document C(2023)3851

    COMMISSION DELEGATED REGULATION (EU) /... supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control, or to the protection and restoration of biodiversity and ecosystems and for determining whether that economic activity causes no significant harm to any of the other environmental objectives and amending Delegated Regulation (EU) 2021/2178 as regards specific public disclosures for those economic activities

    C/2023/3851 final

    EXPLANATORY MEMORANDUM

    1.CONTEXT OF THE DELEGATED ACT

    1.1. General background and objective

    The European Green Deal 1  and the transition to a climate-neutral and sustainable economy by 2050 present opportunities but also challenges for the EU. Investment in the green transition will help make Europe the first climate neutral continent, will help protect, conserve and enhance the EU’s natural capital, and protect the health and well-being of citizens from environment-related risks and impacts. Investments in clean energy and energy efficiency will strengthen the Union’s open strategic autonomy and reduce our reliance on third country fossil fuel imports, helping to moderate energy prices in the future. Investments in our capacity to develop and manufacture clean technologies will also reinforce the EU’s competitiveness. To achieve this, the Union will need to invest an additional EUR 700 billion annually to meet the objectives of the Green Deal 2 . By far the greater part of these investments will have to come from private funding. This is also in line with the Commission priority of building a future-ready economy that works for people and delivers stability, jobs, growth and investment. 

    Regulation (EU) 2020/852 of the European Parliament and of the Council 3 (the ‘Taxonomy Regulation’) aims to help channel capital towards activities that substantially contribute to reaching the objectives of the European Green Deal, such as climate neutrality and resilience, zero pollution, preservation of biodiversity and ecosystems, the transition to a circular economy and sustainable use of water and marine resources. By providing companies, investors and policymakers with definitions of economic activities that can be considered to be environmentally sustainable, the Taxonomy Regulation is expected to help direct investments in economic sectors where they are most needed for a fair green transition.

    This framework helps to increase transparency, mitigate the risk of ‘greenwashing’ and avoid the market fragmentation that can be caused by a lack of common understanding on what constitutes environmentally sustainable economic activities. The Taxonomy Regulation does not impose any obligation on investors to invest in those economic activities that meet specific criteria laid down in that Regulation.

    The Taxonomy Regulation lays down the framework for the EU Taxonomy by setting out four conditions that an economic activity must meet to qualify as environmentally sustainable. A qualifying activity must:

    (i)    contribute substantially to one or more of the six environmental objectives 4 set out in Article 9 of the Taxonomy Regulation in accordance with Articles 10 to 16 of that Regulation;

    (ii)    do no significant harm to any of the other environmental objectives in accordance with Article 17 of that Regulation;

    (iii)    be carried out in compliance with the minimum (social) safeguards set out in Article 18 of the Taxonomy Regulation;

    (iv)    comply with the technical screening criteria set out by the Commission through delegated acts in accordance with Articles 10 (3), 11(3), 12(2), 13(2), 14(2) and 15(2) of the Taxonomy Regulation. The technical screening criteria operationalise the conditions (i) and (ii) by specifying the performance requirements for any economic activity that determine under what conditions that activity: (i) makes a substantial contribution to a given environmental objective; and (ii) does not significantly harm the other environmental objectives.

    The Commission adopted on 4 June 2021 Commission Delegated Regulation (EU) 2021/2139 5 establishing technical screening criteria under which certain economic activities qualify as contributing substantially to climate change mitigation or climate change adaptation and not causing significant harm to any of the other relevant environmental objectives (the ‘Taxonomy Climate Delegated Act’). On 6 July 2021 the Commission adopted Commission Delegated Regulation (EU) 2021/2178 6  specifying the content, methodology, and presentation of the information to be disclosed by both non-financial and financial undertakings that are required to report about the eligibility and alignment of their activities with the EU Taxonomy (the ‘Taxonomy Disclosures Delegated Act’). On 9 March 2022, the Commission adopted Commission Delegated Regulation (EU) 2022/1214 7 amending the Taxonomy Climate Delegated Act and the Taxonomy Disclosures Delegated Act. These amendments included certain activities in the EU Taxonomy on energy generation from nuclear energy and from natural gas and set out specific disclosure requirements for those activities.

    This Delegated Act (the ‘Taxonomy Environmental Delegated Act’) specifies the technical screening criteria under which certain economic activities in the sectors of manufacturing, water supply, sewerage, waste management and remediation, construction, civil engineering, disaster risk management, information and communication, environmental protection and restoration activities and accommodation activities, qualify as contributing substantially to: (i) the sustainable use and protection of water and marine resources; (ii) the transition to a circular economy; (iii) pollution prevention and control; or  (iv) the protection and restoration of biodiversity and ecosystems. This Act also specifies criteria for determining whether those economic activities cause significant harm to any of the other environmental objectives. This Act prioritises those economic activities and sectors that were identified as having the biggest potential to make a substantial contribution to one or more of the four environmental objectives and for which it was possible to develop or refine the recommended criteria without further delay. For certain sectors and activities, such as agriculture, forestry or fishing, as well as certain manufacturing activities, a further assessment and calibration of criteria will be needed 8 .

    As climate change is likely to affect all sectors of the economy, all sectors of the economy will need to be adapted to the adverse impact of the current climate and the expected future climate. The Taxonomy Climate Delegated Act therefore established technical screening criteria for climate change adaptation for all sectors and economic activities that were covered by the technical screening criteria for climate change mitigation. Due to time constraints, the Platform and the Commission were not able at this stage to develop adaptation criteria also for the activities included in the Taxonomy Environmental Delegated Act to make them adapted to climate change. The Commission aims to develop technical screening criteria for relevant activities to make them adapted to climate change in the future.

    This Delegated Act also amends the Taxonomy Disclosures Delegated Act to ensure that the disclosure requirements laid down in it are consistent with the provisions of the Taxonomy Environmental Delegated Act and to correct a small number of technical mistakes and inconsistencies.

    The amending Delegated Act is part of a regulatory package that also includes the Delegated Act amending the Taxonomy Climate Delegated Act, which sets out the technical screening criteria for climate change mitigation and climate change adaptation for additional economic activities not yet included in that Delegated Act. It also introduces limited amendments of a technical nature to improve the implementation of the Taxonomy Climate Delegated Act.

    1.2. Legal background

    This Delegated Act is based on the empowerments set out in Articles 8(4), 12(2), 13(2), 14(2) and 15(2) of the Taxonomy Regulation. The technical screening criteria are set in accordance with the requirements of Article 19 of that Regulation.

    In accordance with Article 31 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making 9 , this Delegated Act combines five interrelated empowerments of the Taxonomy Regulation in a single act. These are the empowerments laid down in Articles 12(2), 13(2), 14(2) and 15(2) related to the technical screening criteria for the sustainable use and protection of water and marine resources, transition to a circular economy, pollution prevention and control and protection, and restoration of biodiversity and ecosystems respectively and an empowerment in Article 8(4) on the information to be disclosed by undertakings that are subject to an obligation to publish non-financial information pursuant to Article 19a or Article 29(a) of Directive 2013/34/EU of the European Parliament and of the Council 10  (the ‘Accounting Directive’).

    2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

    This Delegated Act builds on the recommendations of the Platform on Sustainable Finance (PSF), a Commission expert group set up in 2020 composed of diverse private and public sector stakeholders. The PSF is mandated under Article 20 of the Taxonomy Regulation to advise the Commission on the technical screening criteria for the six environmental objectives of the EU Taxonomy.

    Building on a prioritisation of economic activities with the biggest potential to make a substantial contribution to one of the four environmental objectives of the EU Taxonomy, the Platform developed draft technical screening criteria for a number of activities.

    The draft technical screening criteria proposed by the Platform were published for stakeholder feedback from August to September 2021. The feedback provided by stakeholders was considered by the Platform before the publication of its final recommendations in March and November 2022 11 . The final recommendations of the Platform were also discussed with the Member States Expert Group (MSEG) of the Commission on several occasions in particular on 6 April, 8 July, 4 October and 15 December 2022 and on 24 January 2023.  

    The Commission considered the recommended technical screening criteria developed by the Platform and conducted further work to ensure that the criteria meet the requirements set out in Article 19 of the Taxonomy Regulation. The draft delegated act was shared with the MSEG and the Platform on 5 April 2023 and was published, together with the proposed amendments to the Taxonomy Climate Delegated Act and the amendments to the Taxonomy Disclosures Delegated Act, for four weeks to gather stakeholder feedback from 5 April to 3 May 2023. In total, 636 respondent provided feedback 12 .

    The draft delegated act was also discussed with the Platform on Sustainable Finance on 19 April and 24 May 2023. The draft delegated act was also presented to and discussed with the Member States’ experts and observers from the European Parliament, at meetings of the MSEG on 20 April 2023 and 25 May 2023. An ad hoc discussion with the Members of European Parliament also took place on 25 May 2023.

    Overall, the Platform, MSEG and stakeholders’ feedback was positive and welcomed the inclusion of new objectives and sectors into the EU Taxonomy. Several concerns were expressed, in particular as regards the lack of inclusion of certain sectors considered as critical, noting potential implications for undertakings whose activities are not covered under the Taxonomy. Comments were largely polarised between those proposing more or less stringent criteria. Some considered the calibration of the criteria for certain activities as insufficiently ambitious. Others considered some of the criteria as too ambitious, complex or narrow. Many comments also focused on the usability of the criteria, reporting modalities and technical clarifications.

    Based on careful examination of the feedback received, some targeted calibrations of certain criteria as well as other technical modifications were made during the finalisation of the Delegated Regulation. These concern, in particular, technical clarifications, alignments to ensure greater consistency with existing sectoral legislation, the inclusion of references to upcoming reviews, as well as alignments to improve the coherence of the ‘do no significant harm’ criteria for several activities.

    Most comments related to the activities contributing to the circular economy objective, in particular in the sectors of manufacturing, construction and water and waste activities. A summary of the feedback received during the public feedback period is set out in Annex 7.2 of the Staff Working Document accompanying this Delegated Regulation. The main changes introduced to the criteria after the feedback period are outlined in chapter 4 of the Staff Working Document, classified by objective and sector.

    Activities making substantial contribution to the sustainable use and protection of water and marine resources – Annex I

    Based on the feedback received, changes were mostly technical. Targeted amendments were made, especially to the activity Urban Waste Water Treatment to clarify technical issues and align better with the EU water framework. For nature based solutions, the activity description was amended to extend its scope to cover lakes as they are part of the river network. In addition, the DNSH criteria were changed to ensure coherence between this activity and other, closely related activities included in the Taxonomy Climate Delegated Act (and its amendments) and the Environmental Delegated Act.

    Activities making substantial contribution to the transition to a circular economy– Annex II

    For manufacturing, changes were mostly focused on improving the usability of the criteria. For manufacturing of plastic packaging goods, the feedback received was largely calling for aligning the Taxonomy criteria with the Commission’s proposal for a revision of EU legislation on Packaging and Packaging Waste. With this regard, the Commission amended the text on use of recycled content, design for reuse, rotations and systems for reuse, as well as on the recyclability of the product. The Commission also adjusted the ambition level of the criteria for the use of circular feedstock and introduced new targets based on environmental, social and economic impacts that have been assessed in the impact assessment accompanying the Commission’s Proposal for a Packaging and Packaging Waste Regulation. The updated targets ensure that the Taxonomy criteria are more stringent than the upcoming revised legislation but are at the same time more usable given the current technological availability. For criteria on manufacturing of electrical and electronic equipment, the Commission clarified that criteria apply only where relevant for specific product and do not exclude products where is impossible to comply with criteria due to the nature of the product. The Commission also amended the initially provision on components “rich in critical raw material” to make the provision clearer and more usable in practice.

    For the construction and real estate activities included in the delegated act, limited changes were introduced to provide clarifications or definitions of the technical terms used and to align the wording of the substantial contribution criteria across the activities included in this sector. In addition, the DNSH criteria were modified to ensure coherence between the activities and other, closely related activities included in the Taxonomy Climate Delegated Act (and its amendments) and the Environmental Delegated Act.

    Modifications were also introduced for the activity Provision of IT/OT data-driven solutions to make it coherent with the related activity for the water objective, and to improve the usability of the substantial contribution criteria. For instance, for the substantial contribution criteria 2 to 7, it was specified that operators only need to meet one (or two) of the listed capabilities for each IT/OT data driven solution to comply with the respective criterion.

    As regards waste and water activities as well as services activities, most changes were technical or aimed to provide clarifications.

    Activities making substantial contribution to the pollution prevention and control – Annex III

    As regards manufacturing of active pharmaceutical ingredients (API) or drug substances and of pharmaceutical products, as well as waste and remediation activities, changes were mostly technical or aimed to help clarify the activity description or the application of the technical screening criteria.

    Activities making substantial contribution to the protection and restoration of biodiversity and ecosystems – Annex IV

    Based on diversity of the feedback received, targeted changes were made to the conservation activity. The main changes concerned clarification of the formulation regarding offsetting, in order to clarify that only net biodiversity gains could be counted under the conservation activity. Furthermore, changes were made limiting the use of fertilisers including manure to where it is necessary to achieve the conservation and restoration objectives and following best practices and in compliance with applicable law.

    Limited changes were made also to the tourism activity, in particular clarifying that an analysis of the so called ‘carrying capacity’, i.e. the maximum number of people that may visit a tourist destination at the same time without causing destruction, is required and bringing more flexibility as regards requirements relating to sourcing of certified products.

    Changes to the Taxonomy Disclosures Delegated Act – Annexes V to VIII

    Stakeholders welcomed the proposed amendments to the Disclosures Delegated Act to accommodate reporting against all environmental objectives into the reporting framework, including the activities covered by this Regulation. They also welcomed the technical corrections improving the usability of the reporting framework.

    Additional technical corrections were made based on the feedback received from the stakeholders, including the Platform and Member States. Those include in particular the harmonisation of codes for economic activities and further consistency and usability improvements across the Annexes of the Disclosures Delegated Act for non-financial and financial undertakings. Some stakeholders requested more time for implementation or made more substantive proposals for modifications of the reporting framework, such as inclusion of exposures to SMEs in the banking disclosures, that could be considered later within the broader review of the reporting framework provided under Article 9 of the Disclosures Delegated Act.

    3.ASSESSMENT OF IMPACTS

    The Commission carried out an assessment of impacts of the Delegated Act. The assessment of impacts did not take the form of a formal impact assessment. This is because the Delegated Act follows the policy choices already made in the Taxonomy Regulation and, to a large extent in the Taxonomy Climate Delegated Act. The Taxonomy Regulation was subject to an impact assessment 13 that provided an assessment of the economic, social and environmental impacts of reporting under the EU Taxonomy. The Taxonomy Climate Delegated Act was accompanied by a proportionate impact assessment 14  that outlined in detail the general approaches taken to specifying technical screening criteria. That assessment remains relevant for the technical screening criteria for the environmental objectives.

    This Delegated Act is supported by an analytical Staff Working Document 15 that: (i) describes the context and purpose of the initiative; (ii) explains the approach taken for the definition of the specific technical screening criteria, including how those criteria are expected to work in practice; (iii) explains any divergences or additions made to the Platform’s recommendations; (iv) summarises the expected benefits and costs of this initiative, including, in particular administrative costs; and (v) describes how this initiative will be monitored and evaluated.

    The Commission assessed, the consistency of this Delegated Act with the climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119 of the European Parliament and of the Council 16 and with the objective of ensuring progress on adaptation as referred to in Article 5 of that Regulation.

    In accordance with the requirements set out in Article 17 of the Taxonomy Regulation, the Commission calibrated the technical screening criteria for ensuring that economic activities that contribute substantially to one of the environmental objectives do not cause significant harm (DNSH) to climate change mitigation to ensure that no activity that leads to significant greenhouse gas (GHG) emissions can be considered to be environmentally sustainable. The potential of high GHG emissions and thus significant harm to the climate change mitigation objective has been considered for each economic activity. For activities that have such potential, the DNSH to mitigation criteria were developed. For activities that have a low risk of high GHG emissions, no criteria were proposed. Wherever possible and appropriate, these DNSH to mitigation criteria cross-reference to compliance with minimum requirements set out in EU law. Where EU legislation does not prescribe specific minimum performance related to environmental ambition, quantitative metrics in legislation were used, such as EU Emission Trading System (ETS) installation data. The criteria can be both quantitative, such as GHG emissions, and qualitative, such as a requirement to have a methane leakage monitoring plan.

    Similarly, the Commission calibrated the technical screening criteria to ensure that economic activities that contribute substantially to one of the environmental objectives do not cause significant harm to climate change adaptation. This ensures that no activity can be considered to be environmentally sustainable if it leads to an increased adverse impact of the current climate and the expected future climate, on the activity itself or on people, nature or assets.

    The approach taken to set out the DNSH to adaptation reflects the idea that adaptation is everyone’s responsibility and that all levels of governance should climate-proof their decisions and operations, including private individuals and economic operators. The DNSH to adaptation is based on whether the activity is climate-proof, i.e. whether any existing and future impacts that are material to the activity are identified, and solutions are found to minimise or avoid possible losses or impact on business continuity. The DNSH criteria set out a process-based requirement that is the same across all economic activities. This process-based requirement is proposed for all activities following the approach that climate change will affect the whole economy.

    4.LEGAL ELEMENTS OF THE DELEGATED ACT

    The right to adopt delegated acts is provided for under Articles 8(4), 12(2), 13(2), 14(2) and 15(2) of the Taxonomy Regulation.

    Article 1 lays down the technical screening criteria for the sustainable use and protection of water and marine resources.

    Article 2 lays down the technical screening criteria for the transition to a circular economy.

    Article 3 lays down the technical screening criteria for pollution prevention and control.

    Article 4 lays down the technical screening criteria for the protection and restoration of biodiversity and ecosystems.

    Article 5 lays down the amendments to the Taxonomy Disclosures Delegated Act.

    Article 6 lays down the rules on the entry into force and the date of application of this Regulation.

    COMMISSION DELEGATED REGULATION (EU) …/...

    of 27.6.2023

    supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control, or to the protection and restoration of biodiversity and ecosystems and for determining whether that economic activity causes no significant harm to any of the other environmental objectives and amending Delegated Regulation (EU) 2021/2178 as regards specific public disclosures for those economic activities

    (Text with EEA relevance)

    THE EUROPEAN COMMISSION,

    Having regard to the Treaty on the Functioning of the European Union,

    Having regard to Regulation (EU) 2020/852 of the European Parliament and of the Council on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 17 , and in particular Articles 8(4), 12(2), 13(2), 14(2) and 15(2) thereof,

    Whereas:

    (1)Regulation (EU) 2020/852 establishes the general framework for determining whether an economic activity qualifies as environmentally sustainable for the purposes of establishing the degree to which an investment is environmentally sustainable. That Regulation applies to measures adopted by the Union or by Member States that set out requirements for financial market participants or issuers in respect of financial products or corporate bonds that are made available as environmentally sustainable, to financial market participants that make available financial products, and to undertakings that are subject to the obligation to publish a non-financial statement pursuant to Article 19a of Directive 2013/34/EU of the European Parliament and of the Council 18 or a consolidated non-financial statement pursuant to Article 29a of that Directive. Economic operators or public authorities that are not covered by Regulation (EU) 2020/852 may also apply that Regulation on a voluntary basis.

    (2)Articles 12(2), 13(2), 14(2) and 15(2) of Regulation (EU) 2020/852 require the Commission to adopt delegated acts establishing the technical screening criteria for determining the conditions under which a specific economic activity qualifies as contributing substantially to the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control or to the protection and restoration of biodiversity and ecosystems, respectively, and to establish, for each relevant environmental objective laid down in Article 9 of that Regulation, technical screening criteria for determining whether that economic activity causes no significant harm to one or more of those environmental objectives.

    (3)The Communication from the Commission of 6 July 2021 ‘Strategy for Financing the Transition to a Sustainable Economy’ 19  announced the establishment of technical screening criteria for environmental objectives covering the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control, and to the protection and restoration of biodiversity and ecosystems. Those technical screening criteria should be adopted in addition to the technical screening criteria established in Commission Delegated Regulation (EU) 2021/2139 20 .

    (4)The technical screening criteria for environmental objectives covering the sustainable use and protection of water and marine resources, the transition to a circular economy, pollution prevention and control, and the protection and restoration of biodiversity and ecosystems, should, like the technical screening criteria established in Delegated Regulation (EU) 2021/2139, where possible, follow the classification of economic activities laid down in the NACE Revision 2 classification system of economic activities established by Regulation (EC) No 1893/2006 of the European Parliament and of the Council 21 . To facilitate the identification by undertakings and financial market participants of the relevant economic activities for which technical screening criteria should be established, the specific description of an economic activity should also include indicative references to NACE codes that can be associated with that activity. Those references should be understood as indicative and should not prevail over the specific definition of the economic activity provided in its description.

    (5)The technical screening criteria for economic activities that contribute substantially to the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control, and to the protection and restoration of biodiversity and ecosystems should ensure that the economic activity concerned has a positive impact on one of those objectives. Those technical screening criteria should therefore refer to thresholds or performance levels that the economic activity should achieve to qualify as contributing substantially to one of those objectives. The technical screening criteria for ‘do no significant harm’ (DNSH) should ensure that the economic activity has no significant negative environmental impacts, including climate-related impacts. Consequently, those technical screening criteria should specify the minimum requirements that the economic activity should meet to qualify as environmentally sustainable.

    (6)The technical screening criteria for determining whether an economic activity contributes substantially to one of the environmental objectives laid down in Article 9 of Regulation (EU) 2020/852 and does no significant harm to any of the other environmental objectives should, where relevant build, on existing Union law, best practices, standards and methodologies, and well-established standards, practices and methodologies developed by internationally reputed public entities. Where those standards, practices and methodologies are not available for a specific policy area, the technical screening criteria should build on well-established standards developed by internationally reputed private bodies.

    (7)Pursuant to Article 19(1), point (h), of Regulation (EU) 2020/852, the technical screening criteria should take into account the nature and the scale of the economic activity and sector that they refer to, and whether the economic activity is an enabling activity as referred to in Article 16 of that Regulation. For the technical screening criteria to meet the requirements of Article 19 of Regulation (EU) 2020/852 in an effective and balanced way, those technical screening criteria should be set as a quantitative threshold or minimum requirement, a relative improvement, a set of qualitative performance requirements, process or practice-based requirements, or a precise description of the nature of the economic activity itself where that activity by its nature can contribute substantially to the environmental objectives.

    (8)The technical screening criteria for determining under which conditions an economic activity qualifies as contributing substantially to the sustainable use and protection of water and marine resources should reflect the need to achieve good status for all water bodies and good environmental status for marine waters, and to prevent the deterioration of water bodies that already have good status or marine waters that are already in good environmental status. It is therefore appropriate to focus first on those economic activities and sectors that have the greatest potential to achieve those aims.

    (9)The Union framework for water protection 22  ensures an integrated approach to water management, respecting the integrity of whole ecosystems. The technical screening criteria should therefore aim at addressing the adverse effects of urban and industrial waste water discharges, protecting human health from the adverse impact of any contamination of water intended for human consumption, improving water management and the efficiency of water use, ensuring the sustainable use of marine ecosystem services, contributing to the good environmental status of marine waters and to the overall achievement and maintenance of good status or good potential of bodies of water, including bodies of surface water and groundwater. Technical screening criteria for urban waste water treatment as activity providing a substantial contribution to one or more environmental objectives should be reviewed and where necessary revised, taking into account relevant Union law, including Council Directive 91/271/EEC 23 .

    (10)As regards solutions inspired and supported by nature, which provide environmental, social and economic benefits and help build resilience, the technical screening criteria should aim at preventing and protecting against floods or droughts while enhancing natural water retention, biodiversity and water quality.

    (11)The transition to a circular economy is an enabler of environmental sustainability that generates significant benefits for the sustainable management of water, the protection and conservation of biodiversity, the prevention and control of pollution and the mitigation of climate change. The circular economy reflects the need for economic activities to promote efficient use of resources through appropriate re-use and recycling of resources. The technical screening criteria for determining under which conditions an economic activity qualifies as contributing substantially to the transition to a circular economy should therefore ensure that in the design and production phase, the operator takes into account the long-term value retention and waste reduction of the product over its lifecycle. During its use phase, the product should be subject to maintenance to extend its life, while reducing the amount of waste. The product should be dismantled or treated after its use to ensure that it can be re-used or recycled for the manufacturing of another product. That approach can limit the dependency of the Union’s economy on materials imported from third countries, which is particularly important in respect of critical raw materials. It is therefore appropriate to focus first on those economic activities and sectors that have the greatest potential to achieve those aims.

    (12)When considering the circularity of a product, the design and production phases are key for ensuring durability and potential re-use of the product and for its recyclability. Those phases are also imperative for reducing the content of hazardous substances and substituting substances of very high concern in materials and products throughout their life cycle. The technical screening criteria for manufacturing activities that substantially contribute to the transition to circular economy should therefore set design requirements for products’ longevity, reparability, and reuse, as well as requirements on the use of materials, substances and processes that allow for quality recycling of the product. The use of hazardous substances should be minimised. Where possible, the criteria should also require the use of recycled materials for the manufacturing of the product itself.

    (13)In the follow-up to Communications from the Commission of 11 December 2019 ‘The European Green Deal’ 24 , of 3 March 2020 on a new Circular Economy Action Plan 25 , of 16 January 2018 European Strategy for Plastics 26 and of 30 November 2022 on an EU Policy framework on biobased, biodegradable and compostable plastics 27 , the technical screening criteria for plastic packaging manufacturing should be complemented, reviewed and where necessary revised and taking into account relevant Union law, including Directive 94/62/EC of the European Parliament and of the Council 28 and its future revisions.

    (14)In the absence of legally agreed sustainability criteria on the role of biomass in plastic packaging, the technical screening criteria for manufacturing of plastic packaging making substantial contribution to the transition to a circular economy focus on use of bio-waste feedstock. Taking into account future technology and policy developments, including the review of Directive 2018/2001/EC of the European Parliament and of the Council 29 , as well as possible contribution to other environmental objectives, those criteria may need to be reviewed.

    (15)Good waste management is a building block of the circular economy and helps prevent waste from having a negative impact on the environment and human health. The Union legislation on waste 30 improves waste management by setting out a ’waste hierarchy’ under which waste prevention, preparing for re-use and recycling are the preferred options, followed by other recovery, including energy recovery and only as a last resort, disposal such as incineration without energy recovery or landfilling. The technical screening criteria for determining the conditions under which a specific economic activity qualifies as contributing substantially to the transition to a circular economy should therefore aim at preventing or reducing waste generation, increasing the preparation for re-use and recycling of waste, avoiding down cycling and disposal of waste. Taking into account that materials suitable for being reintroduced into the circular economy, such as metals and inorganic salts, can be recycled from combustion products, in particular from bottom ashes from non-hazardous waste incineration, the establishment of technical screening criteria for that recycling activity is to be considered.

    (16)Construction and demolition is responsible for 37% of waste in the Union 31 . Ensuring that the materials used in the construction and maintenance process of buildings and other civil engineering objects come mainly from re-used or recycled (secondary raw) materials; and are in turn prepared for re-use or recycling when the built asset is demolished, can therefore play an important role in the transition to a circular economy. Technical screening criteria therefore should be laid down for the construction of new buildings, renovation of existing buildings, demolition or wrecking of buildings and other structures, maintenance of roads and motorways and for the use of concrete in civil engineering projects. Considerations of the circularity of the materials and the built asset need to be taken into account in the design phase, up until the dismantling phase. The technical screening criteria should therefore follow the principles of circular design and production of the built asset, as well as a circular use of materials used to produce that asset.

    (17)A whole new range of sustainable services, product-as-a-service business models and digital solutions brings about a better quality of life, innovative jobs and upgraded knowledge and skills. In line with the Communication of the Commission of 11 March 2020 ‘A new Circular Economy Action Plan For a cleaner and more competitive Europe’ 32 , circular economy provides high-quality, functional and safe products, which are efficient and affordable, last longer and are designed for re-use, repair and high-quality recycling. The technical screening criteria for determining the conditions under which innovative sustainable services qualify as contributing substantially to the transition to a circular economy should therefore be laid down for activities that contribute to prolonging the life of products.

    (18)Digital solutions, including the use of digital product passports, can provide real-time data about an item’s location, condition, and availability, and increase the traceability of materials and that way enhance value retention in every design, manufacturing and consumer decision. That in turn enables economic actors to move to circular business models, including product-as-a-service business model, ultimately decoupling economic activities from the use of natural resources and improving an economic activity’s environmental impacts. Technical screening criteria should therefore be established for new digital solutions that can improve the transparency and efficiency of environmental monitoring and regulatory enforcement, including decision-making within integrated water resources management.

    (19)The technical screening criteria for determining under which conditions an economic activity qualifies as contributing substantially to pollution prevention and control should reflect the need to eliminate pollution in air, water, soil, living organisms and food resources. Pollution can cause illnesses and in consequence may lead to premature deaths. Its most harmful impacts on human health are typically borne by the most vulnerable groups 33 . Pollution also threatens biodiversity and contributes to the mass extinction of species. As outlined in the Communication from the Commission of 12 May 2021, Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil' 34 , the economic benefits of fighting pollution are substantial and the benefits for society far outweigh the required costs.

    (20)Following the ambition of the Communication from the Commission of 14 October 2020 ‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’ 35 , to help to prevent and control pollution it is particularly important to progressively phase out the most harmful substances from products for consumer or professional use except when their use has been proven to be essential for society and to substitute or minimise the production and use of substances of concern, as far as possible.

    (21)Pollution caused by certain pharmaceutical ingredients may pose risks to the environment and to human health as outlined in the Communication from the Commission of 11 March 2019 ‘European Union Strategic Approach to Pharmaceuticals in the Environment’ 36 . Technical screening criteria for the manufacturing of active pharmaceutical ingredients or active substances and for the manufacturing of medicinal products should therefore aim at promoting the production and use of ingredients that are naturally occurring substances or are classified as readily biodegradable.

    (22)Preventing and reducing emission of pollutants in the end-of-life phase of products, and the cleaning-up of existing pollution, have a significant potential to protect the environment from pollution and to improve the state of the environment. Technical screening criteria should therefore be established for the collection, transport and treatment of hazardous waste which poses a greater risk to the environment and human health than non-hazardous waste, as well as for remediation of non-conforming landfills and abandoned or illegal waste dumps and of contaminated sites and areas.

    (23)The technical screening criteria for determining under which conditions an economic activity qualifies as contributing substantially to the protection and restoration of biodiversity and ecosystems should reflect the need to protect, conserve or restore biodiversity to achieve the good condition of ecosystems or to protect ecosystems that are already in good condition. Loss of biodiversity and collapse of ecosystems are one of the biggest threats facing humanity in the next decade 37 .

    (24)Conservation of biodiversity has direct economic benefits for many sectors of the economy. The technical screening criteria should therefore aim at maintaining or improving the status and trends of terrestrial, freshwater and marine habitats, ecosystems and populations of related fauna and flora species.

    (25)The value of biodiversity and of the associated services provided by healthy ecosystems is important for tourism as it contributes significantly to the attractiveness and quality of tourism destinations, and therefore to their competitiveness. Technical screening criteria should therefore be established for tourism accommodation activities and should aim at ensuring that those activities follow appropriate principles and minimum requirements to protect and sustain the biodiversity and ecosystems, and to contribute to their conservation.

    (26)The technical screening criteria for determining whether the economic activities that contribute substantially to one of the environmental objectives cause no significant harm to any of the other environmental objectives should aim at ensuring that contribution to one of the environmental objectives is not made at the expense of other environmental objectives. The ‘do no significant harm’ criteria play therefore an essential role in ensuring the environmental integrity of the classification of environmentally sustainable activities. The ‘do no significant harm’ criteria for a given environmental objective should be specified for those activities that present a risk of causing significant harm to that objective. Those criteria should take into account and build upon the relevant requirements of existing Union law.

    (27)The technical screening criteria for ensuring that activities that contribute substantially to one of the environmental objectives do not cause significant harm to climate change mitigation should ensure that economic activities that have the potential to contribute substantially to environmental objectives other than climate change mitigation do not lead to significant greenhouse gas emissions. 

    (28)Climate change is likely to affect all sectors of the economy. The technical screening criteria for ensuring that economic activities that contribute substantially to one of the environmental objectives do not cause significant harm to climate change adaptation should therefore apply to all of those economic activities. Those criteria should ensure that existing and future risks that are material to the economic activity are identified and that adaptation solutions are implemented to minimise or avoid possible losses or impacts on business continuity.

    (29)The technical screening criteria for ‘do no significant harm’ to sustainable use and protection of water and marine resources should be specified for all activities that may hinder such sustainable use and protection. Those criteria should aim at avoiding that economic activities are detrimental to the good status or the good ecological potential of water bodies, including surface water and groundwater, or to the good environmental status of marine waters, by requiring that environmental degradation risks are identified and addressed, in accordance with a water use and protection management plan or with the Member States’ marine strategies.

    (30)The technical screening criteria for ‘do no significant harm’ to transition to a circular economy should be tailored to specific economic activities to ensure that those activities do not lead to inefficiencies in the use of resources or to lock-in linear production models, and that waste is avoided or reduced and, where unavoidable, managed in accordance with the waste hierarchy. Those criteria should also ensure that economic activities do not undermine the objective of transitioning to a circular economy.

    (31)The technical screening criteria for ‘do no significant harm’ to pollution prevention and control should reflect sector specificities to address the relevant sources and types of pollution into air, water or land, referring, where relevant, to best available techniques conclusions established under Directive 2010/75/EU of the European Parliament and of the Council 38 .

    (32)The criteria for ‘do no significant harm’ to protection and restoration of biodiversity and ecosystems should be specified for all activities that can pose risks to the status or condition of habitats, species or ecosystems and should require that, where relevant, environmental impact assessments or other appropriate assessments are undertaken and the conclusions from such assessments are implemented. Those criteria should ensure that even in the absence of a requirement to perform an environmental impact assessment or other appropriate assessment, activities do not lead to the disturbance, capturing or killing of legally protected species or the deterioration of legally protected habitats.

    (33)As climate change is likely to affect all sectors of the economy, all sectors of the economy will need to be adapted to the adverse impact of the current climate and the expected future climate. Technical screening criteria for substantial contribution to climate change adaptation are to be therefore established in the future for all sectors and economic activities that are covered by the technical screening criteria for substantial contribution to the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control or to the protection and restoration of biodiversity and ecosystems set out in this Regulation.

    (34)The inclusion of new economic activities contributing to environmental objectives pursuant to Articles 12(2), 13(2), 14(2), and 15(2) of Regulation (EU) 2020/852 will widen the coverage of disclosures laid down in Article 8 of that Regulation. Commission Delegated Regulation (EU) 2021/2178 39 , which was adopted on the basis of Article 8(4) of Regulation (EU) 2020/852, should therefore be amended to reflect that widened scope. To address certain technical and legal inconsistencies identified since the application of Delegated Regulation (EU) 2021/2178, targeted amendments should also be introduced to that Regulation.

    (35)Delegated Regulation (EU) 2021/2178 should therefore be amended accordingly.

    (36)The four environmental objectives referred to in Article 9, points (c) to (f), of Regulation (EU) 2020/852 and in Articles 12, 13, 14 and 15 of that Regulation are closely interlinked in terms of the means by which an objective is achieved and the benefits that achieving one of the objectives may have on other objectives. The provisions determining whether an economic activity contributes substantially to the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control or to the protection and restoration of biodiversity and ecosystems, are thus closely interrelated, and are closely linked to the need to widen the disclosure obligations laid down in Delegated Regulation (EU) 2021/2178. To ensure coherence between those provisions, which should enter into force at the same time, to facilitate a comprehensive view of the legal framework for stakeholders and to facilitate the application of Regulation (EU) 2020/852, it is necessary to include those provisions in a single Regulation.

    (37)To ensure that the application of Regulation (EU) 2020/852 evolves with scientific, technological, market and policy developments, this Regulation should be regularly reviewed and, where appropriate, amended as regards the activities considered to be contributing substantially to the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control, to the protection and restoration of biodiversity and ecosystems, and the corresponding technical screening criteria.

    (38)This Regulation is consistent with the climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119 of the European Parliament and of the Council 40 and ensures progress on adaptation as referred to in Article 5 of that Regulation. The Commission assessed the consistency of the technical screening criteria for ensuring that economic activities that contribute substantially to one of the environmental objectives do not cause significant harm to climate change mitigation and climate change adaptation with the objective and targets of Regulation (EU) 2021/1119 as required by Article 6(4) of that Regulation.

    (39)It is necessary to provide non-financial and financial undertakings with sufficient time to assess whether their economic activities comply with the technical screening criteria laid down in this Regulation, and to report on the basis of that assessment in accordance with Delegated Regulation (EU) 2021/2178. The date of application of this Regulation should therefore be deferred, while the amendments to Delegated Regulation (EU) 2021/2178 should ensure that non-financial and financial undertakings have sufficient time to comply with their reporting requirements under that Regulation,

    HAS ADOPTED THIS REGULATION:

    Article 1

    Technical screening criteria related to the sustainable use and protection of water and marine resources

    The technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the sustainable use and protection of water and marine resources and for determining whether that economic activity causes no significant harm to any of the other environmental objectives laid down in Article 9 of Regulation (EU) 2020/852 are set out in Annex I to this Regulation.

    Article 2

    Technical screening criteria related to the transition to a circular economy

    The technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the transition to a circular economy and for determining whether that economic activity causes no significant harm to any of the other environmental objectives laid down in Article 9 of Regulation (EU) 2020/852 are set out in Annex II to this Regulation.

    Article 3

    Technical screening criteria related to pollution prevention and control

    The technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to pollution prevention and control and for determining whether that economic activity causes no significant harm to any of the other environmental objectives laid down in Article 9 of Regulation (EU) 2020/852 are set out in Annex III to this Regulation.

    Article 4

    Technical screening criteria related to the protection and restoration of biodiversity and ecosystems

    The technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the protection and restoration of biodiversity and ecosystems and for determining whether that economic activity causes no significant harm to any of the other environmental objectives laid down in Article 9 of Regulation (EU) 2020/852 are set out in Annex IV to this Regulation.

    Article 5

    Amendments to Delegated Regulation (EU) 2021/2178

    Delegated Regulation (EU) 2021/2178 is amended as follows:

    (1)in Article 8, paragraph 5 is deleted;

    (2)in Article 10, the following paragraphs 6 and 7 are added:

    ‘6.     From 1 January 2024 until 31 December 2024, non-financial undertakings shall only disclose the proportion of Taxonomy-eligible and Taxonomy non-eligible economic activities pursuant to Regulation [Taxonomy Environmental Delegated Regulation] and Sections 3.18 to 3.21, Sections 6.18 to 6.20 of Annex I to Delegated Regulation (EU) 2021/2139 and Sections 5.13, 7.8, 8.4, 9.3, 14.1 and 14.2 of Annex II to Delegated Regulation (EU) 2021/2139 in their total turnover, capital and operational expenditure and the qualitative information referred to in Section 1.2 of Annex I relevant for that disclosure.

    The key performance indicators of non-financial undertakings shall cover the economic activities set out in Regulation [Taxonomy Environmental Delegated Regulation] and Sections 3.18 to 3.21, Sections 6.18 to 6.20 of Annex I to Delegated Regulation (EU) 2021/2139 and Sections 5.13, 7.8, 8.4, 9.3, 14.1 and 14.2 of Annex II to Delegated Regulation (EU) 2021/2139 from 1 January 2025.

    7.    From 1 January 2024 until 31 December 2025, financial undertakings shall only disclose:

    (a)the proportion in their covered assets of exposures to Taxonomy non-eligible and Taxonomy-eligible economic activities pursuant to Regulation [Taxonomy Environmental Delegated Regulation] and Sections 3.18 to 3.21, Sections 6.18 to 6.20 of Annex I to Delegated Regulation (EU) 2021/2139 and Sections 5.13, 7.8, 8.4, 9.3, 14.1 and 14.2 of Annex II to Delegated Regulation (EU) 2021/2139;

    (b)the qualitative information referred to in Annex XI relating to economic activities referred to in point (a).

    The key performance indicators of financial undertakings shall cover the economic activities set out in Regulation [Taxonomy Environmental Delegated Regulation] and Sections 3.18 to 3.21, Sections 6.18 to 6.20 of Annex I to Delegated Regulation (EU) 2021/2139 and Sections 5.13, 7.8, 8.4, 9.3, 14.1 and 14.2 of Annex II to Delegated Regulation (EU) 2021/2139 from 1 January 2026.’

    (3)Annexes I, II, III, IV, V, VII, IX and X are amended in accordance with Annex V to this Regulation.

    (4)Annex VI is replaced by the text set out in Annex VI to this Regulation;

    (5)Annex VIII is replaced by the text set out in Annex VII to this Regulation.

    Article 6

    This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

    It shall apply from 1 January 2024.

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

    Done at Brussels, 27.6.2023

       For the Commission

       On behalf of the President,
       Mairead McGUINNESS
       Member of the Commission

    (1)    Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions The European Green Deal COM(2019) 640 final.
    (2)    Commission Staff Working Document on Investment needs assessment and funding availabilities to strengthen EU’s Net-Zero technology manufacturing capacity, SWD(2023) 68 final. Communication from the Commission to the European Parliament, the Council, the European Central Bank, the European Economic and Social Committee, the Committee of Regions: The EU economy after COVID-19: implications for economic governance, COM (2021) 662 final.Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Environmental Implementation Review 2022, Turning the tide through environmental compliance, COM(2022) 438 final.
    (3)    Regulation (EU) 2020/852 of the European Parliament and of the Council on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).
    (4)    The six environmental objectives as defined in the Taxonomy Regulation are as follows: (a) climate change mitigation; (b) climate change adaptation; (c) the sustainable use and protection of water and marine resources; (d) the transition to a circular economy; (e) pollution prevention and control; and (f) the protection and restoration of biodiversity and ecosystem.
    (5)    Commission Delegated Regulation (EU) 2021/2139 of 4 June 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to climate change mitigation or climate change adaptation and for determining whether that economic activity causes no significant harm to any of the other environmental objectives (OJ L 442, 9.12.2021, p. 1).
    (6)    Commission Delegated Regulation (EU) 2021/2178 of 6 July 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by specifying the content and presentation of information to be disclosed by undertakings subject to Articles 19a or 29a of Directive 2013/34/EU concerning environmentally sustainable economic activities, and specifying the methodology to comply with that disclosure obligation (OJ L 443, 10.12.2021, p. 9).
    (7)    Commission Delegated Regulation (EU) 2022/1214 of 9 March 2022 amending Delegated Regulation (EU) 2021/2139 as regards economic activities in certain energy sectors and Delegated Regulation (EU) 2021/2178 as regards specific public disclosures for those economic activities (OJ L 188, 15.7.2022, p. 1).
    (8)    The Staff Working Document accompanying this Regulation provides further clarification regarding the choice of sectors and activities covered.
    (9)    Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1).
    (10)    Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19).
    (11)    All Platform publications are available at: https://finance.ec.europa.eu/sustainable-finance/overview-sustainable-finance-old/platform-sustainable-finance_en#activities
    (12)    All comments received are available at:   https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13237-Sustainable-investment-EU-environmental-taxonomy_en .
    (13)    Commission Staff Working Document Impact Assessment Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on the establishment of a framework to facilitate sustainable investment and Proposal for a Regulation of the European Parliament and of the Council on disclosures relating to sustainable investments and sustainability risks and amending Directive (EU) 2016/2341 and Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2016/1011 on low carbon benchmarks and positive carbon impact benchmarks, SWD/2018/264 final.
    (14)    Commission Staff Working Document Impact Assessment Report Accompanying the document Commission Delegated Regulation (EU) .../... supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to climate change mitigation or climate change adaptation and for determining whether that economic activity causes no significant harm to any of the other environmental objectives, SWD/2021/0152 final.
    (15)    [Placeholder for a reference to the SWD number.]
    (16)    Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1).
    (17)    OJ L 198, 22.6.2020, p. 13.
    (18)    Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19).
    (19)    Communication from the Commission of 6 July 2021 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Strategy for Financing the Transition to a Sustainable Economy, COM/2021/390 final.
    (20)    Commission Delegated Regulation (EU) 2021/2139 of 4 June 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to climate change mitigation or climate change adaptation and for determining whether that economic activity causes no significant harm to any of the other environmental objectives (OJ L 442, 9.12.2021, p. 1).
    (21)    Regulation (EC) No 1893/2006 of the European Parliament and of the Council of 20 December 2006 establishing the statistical classification of economic activities NACE Revision 2 and amending Council Regulation (EEC) No 3037/90 as well as certain EC Regulations on specific statistical domains (OJ L 393, 30.12.2006, p. 1).
    (22)    In particular Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1), Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84), Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19), Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40), Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1), Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19), Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality and repealing Directive 76/160/EEC (OJ L 64, 4.3.2006, p. 37) and Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1).
    (23)    Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).
    (24)    Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions: The European Green Deal (COM(2019) 640 final).
    (25)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A new Circular Economy Action Plan For a cleaner and more competitive Europe (COM/2020/98 final).
    (26)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A European Strategy for Plastics in a Circular Economy (COM/2018/028 final).
    (27)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions EU policy framework on biobased, biodegradable and compostable plastics (COM(2022) 682 final).
    (28)    Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10).
    (29)    Directive 2018/2001/EC of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82).
    (30)    See in particular Article 4 of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
    (31)    Eurostat Statistics Explained database, presenting data collected in accordance with Regulation (EC) No 2150/2002 of the European Parliament and of the Council of 25 November 2002 on waste statistics (OJ L 332, 9.12.2002, p. 1).
    (32)    Communication from the Commission of 11 March 2020 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A new Circular Economy Action Plan For a cleaner and more competitive Europe, COM/2020/98 final.
    (33)    European Environmental Agency Report No 22/2018, Unequal exposure and unequal impacts: social vulnerability to air pollution, noise and extreme temperatures in Europe.
    (34)    Communication from the Commission of 12 May 2021 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil', COM/2021/400 final.
    (35)    Communication from the Commission of 14 October 2020 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment, COM/2020/667 final.
    (36)    Communication from the Commission of 11 March 2019 to the European Parliament, the Council and the European Economic and Social Committee, European Union Strategic Approach to Pharmaceuticals in the Environment, COM/2019/128 final.
    (37)    World Economic Forum (2020), The Global Risks Report 2020.
    (38)    Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17).
    (39)    Commission Delegated Regulation (EU) 2021/2178 of 6 July 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by specifying the content and presentation of information to be disclosed by undertakings subject to Articles 19a or 29a of Directive 2013/34/EU concerning environmentally sustainable economic activities, and specifying the methodology to comply with that disclosure obligation (OJ L 443, 10.12.2021, p. 9).
    (40)    Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1).
    Top

    TABLE OF CONTENTS

    ANNEX I    3

    1.Manufacturing3

    1.1.Manufacture, installation and associated services for leakage control technologies enabling leakage reduction and prevention in water supply systems3

    2.Water supply, sewerage, waste management and remediation activities 5

    2.1.Water supply5

    2.2.Urban Waste Water Treatment8

    2.3.Sustainable urban drainage systems (SUDS)10

    3.Disaster risk management 12

    3.1.Nature-based solutions for flood and drought risk prevention and protection12

    4.Information and communication 16

    4.1.Provision of IT/OT data-driven solutions for leakage reduction16

    ANNEX I

    Technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the sustainable use and protection of water and marine resources and for determining whether that economic activity causes no significant harm to any of the other environmental objectives

    1.Manufacturing

    1.1.Manufacture, installation and associated services for leakage control technologies enabling leakage reduction and prevention in water supply systems

    Description of the activity

    The economic activity manufactures, installs, or provides associated services for leakage control technologies that enable leakage reduction and prevention in water supply systems (WSSs).

    The economic activities in this category could be associated with several NACE codes, in particular E36 and F42.99, in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    An economic activity in this category is an enabling activity in accordance with Article 12(1), point (e), of Regulation (EU) 2020/852 where it complies with the technical screening criteria set out in this Section.

    Technical screening criteria

    Substantial contribution to the sustainable use and protection of water and marine resources

    1. The activity manufactures, installs or provides maintenance, repairs or professional services for leakage control technologies in new or existing water supply systems, aimed at controlling the pressure in district metered areas (DMAs) of the water supply system to a minimum pressure. The leakage control technologies include in particular pressure control valves, pressure transmitters, flow meters and communication devices and special civil works, including manholes to maintain the pressure control valves.

    2. Environmental degradation risks related to preserving water quality and avoiding water stress are identified and addressed with the aim of achieving good water status and good ecological potential as defined in Article 2, points (22) and (23), of Regulation (EU) 2020/852, in accordance with Directive 2000/60/EC 1 and in line with a water use and protection management plan, developed in accordance with that Directive for the potentially affected water body or bodies, in consultation with relevant stakeholders.

    Where an Environmental Impact Assessment is carried out in accordance with Directive 2011/92/EU of the European Parliament and of the Council 2 and where that assessment contains an assessment of the impact on water in accordance with Directive 2000/60/EC, no additional assessment of impact on water is required, provided the risks identified have been addressed.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (4) Transition to a circular economy

    The activity assesses the availability of and, where feasible, adopts techniques that support:

    (a)reuse and use of secondary raw materials and reused components in products manufactured;

    (b)design for high durability, recyclability, easy disassembly and adaptability of products manufactured;

    (c)waste management that prioritises recycling over disposal, in the manufacturing process;

    (d)information on and traceability of substances of concern throughout the life cycle of the manufactured products.

    (5) Pollution prevention and control

    The activity complies with the criteria set out in Appendix C to this Annex.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.Water supply, sewerage, waste management and remediation activities 

    2.1.Water supply

    Description of the activity

    Construction, extension, operation, and renewal of water collection, treatment and supply systems intended for human consumption based on the abstraction of natural resources of water from surface or ground water sources.

    The economic activity includes abstraction of the water resource, necessary treatment to make the quality of water compliant with the applicable legislation and distribution to the population and food business operators in piped systems.

    The economic activity does not cover irrigation and abstraction of water resources for desalination of marine or brackish water.

    The economic activities in this category could be associated with several NACE codes, in particular E36.00 and F42.9, in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the sustainable use and protection of water and marine resources

    1. For the operation of an existing water supply system providing water supply in a sufficient and healthy quality to consumers, and contributing to water resource efficiency, the activity complies with the following criteria:

    (a)the water supply system complies with Directive (EU) 2020/2184, Commission Implementing Decision (EU) 2022/679 3 , and delegated and implementing acts adopted under that Directive;

    (b)the leakage level of the system is either calculated using the Infrastructure Leakage Index (ILI) 4 rating method and the threshold value equals to or is lower than 2.0, or is calculated using another appropriate method and the threshold value is established in accordance with Article 4 of Directive (EU) 2020/2184. That calculation is to be applied across the extent of a specified part of a water supply (distribution) network, i.e., at water supply zone level, district metered area(s) (DMAs) or pressure managed area(s) (PMAs);

    (c)the water supply systems include metering at consumer level, where water is delivered to a contractual delivery point of the consumers’ own drinking water distribution system.

    2. For the construction and operation of a new water supply system, or an extension of an existing water supply system that provides water to new areas or improves that water supply to existing areas, the activity complies with the following criteria:

    (a)the water supply system complies with Directive (EU) 2020/2184, including the requirements set out in Article 13(8) of that Directive, in Implementing Decision (EU) 2022/679, and in delegated and implementing acts adopted under that Directive;

    (b)the leakage level of the new or extension system is either calculated using the Infrastructure Leakage Index (ILI) rating method and the threshold value equals to or is lower than 1.5, or is calculated using another appropriate method and the threshold value is established in accordance with Article 4 of Directive (EU) 2020/2184. That calculation is to be applied across the extent of the affected and specified part of a water supply (distribution) network where the works are carried out, i.e., at water supply zone level, district metered area(s) (DMAs) or pressure managed area(s) (PMAs);

    (c)the water supply system includes metering at consumer level, where water is delivered to a contractual delivery point of the consumers’ own drinking water distribution system.

    3. For renewal of existing water supply systems, the activity complies with the following criteria:

    (a)the activity closes the gap by at least 20% either between the current leakage level averaged over three years, calculated using the Infrastructure Leakage Index (ILI) rating method and an ILI of 1.5, or between the current leakage level averaged over three years, calculated using another appropriate method, and the threshold value established in accordance with Article 4 of Directive (EU) 2020/2184. The current leakage level averaged over three years is calculated across the extent of the affected and specified part of a water supply (distribution) network where the works are carried out i.e., for the renewed water supply (distribution) network at district metered area(s) (DMAs) or pressure managed area(s) (PMAs);

    (b)a plan with goals and timelines for implementing metering at consumer level is issued by the water supplier and approved by the competent authorities.

    4. The water supply system has received the necessary permits for water abstraction. Those abstractions are included in the register for water abstractions, in accordance with Directive 2000/60/EC. An assessment of the actual potential for abstraction has been performed, to ensure that the available groundwater resource is not exceeded by the long-term annual average rate of abstraction or that the surface water body from which water is abstracted is not prevented from achieving good ecological status and ecological potential and the abstractions do not deteriorate status or potential of those water bodies.

    The operation of the water supply system does not result in a deterioration of the status of the affected water bodies, nor does it prevent the water body from achieving good status and good ecological potential in accordance with Directive 2000/60/EC 5 .

    The information in relation to the abstractions, register of abstractions, status of water bodies and pressures and impacts on these is included in a river basin management plan, or, for activities in third countries, in an equivalent water use and protection management plan. 

    The activity does not involve construction of new supply systems or extensions of existing supply systems where they potentially affect one or more water bodies which are not in good status or potential for reasons related to quantity.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (4) Transition to a circular economy

    N/A

    (5) Pollution prevention and control

    N/A

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.2.Urban Waste Water Treatment

    Description of the activity

    Construction, extension, upgrade, operation and renewal of urban waste water infrastructure including treatment plants, sewer networks, storm water management structures, connections to the waste water infrastructure, decentralised wastewater treatment facilities, including individual and other appropriate systems, and discharge structures for treated effluent. The activity may include innovative and advanced treatments, including the removal of micropollutants.

    The economic activities in this category could be associated with several NACE codes, in particular E37.00 and F42.9, in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the sustainable use and protection of water and marine resources

    1. The waste water treatment system does not result in a deterioration of the good status and good ecological potential of any of the affected water bodies and it contributes significantly to the achievement of good status and potential of the affected water bodies, in accordance with Directive 2000/60/EC 6 .

    The information related to the status of water bodies, to the activities potentially impacting the status and to the measures taken to avoid or minimize such impacts, is included in a river basin management plan, or, for activities in third countries, in an equivalent water use and protection management plan. The waste water treatment system fulfils the discharge requirements set up by the competent local authorities. The waste water treatment system also contributes to achieve or maintain the good environmental status of marine waters in accordance with Directive 2008/56/EC, where applicable.

    2. The waste water treatment system has a collecting system and the provision of secondary treatment. The waste water treatment system complies with the relevant, size-specific requirements for discharges from urban waste water treatment plants set out in Directive 91/271/EEC, in particular Articles 3 to 8 and Article 13 of that Directive and Annex I to that Directive.

    3. Where the waste water treatment plant has a capacity of 100 000 population equivalent (p.e.) 7 or more, or of a daily inflow of a five-day biochemical oxygen demand (BOD5) load of more than 6 000 kg, it uses a sludge treatment such as anaerobic digestion or a technology with the same or a lower net energy demand (considering both energy generation and consumption), to stabilise the sludge. 

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    An assessment of the direct GHG emissions from the centralised waste water system, including collection (sewer network) and treatment, has been performed. The results are disclosed to investors and clients on demand 8 .

    For anaerobic digestion of sewage sludge, a monitoring plan is in place for methane leakage at the facility.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (4) Transition to a circular economy

    N/A

    (5) Pollution prevention and control

    Discharges to receiving waters meet the requirements laid down in Directive 91/271/EEC or as required by national provisions stating maximum permissible pollutant levels from discharges to receiving waters.

    Measures have been implemented to avoid and mitigate harmful storm water overflows from the waste water collection system, which may include nature-based solutions, separate storm water collection systems, retention tanks and treatment of the first flush.

    Sewage sludge is used in accordance with Council Directive 86/278/EEC 9 or as required by national law relating to the spreading of sludge on the soil or any other application of sludge on and in the soil.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.3.Sustainable urban drainage systems (SUDS)

    Description of the activity

    Construction, extension, operation and renewal of urban drainage systems facilities that mitigate pollution and flood hazards due to discharges of urban runoff and improve the urban water quality and quantity, by harnessing natural processes, such as infiltration and retention.

    The activity includes SUDS promoting infiltration, evaporation and other stormwater treatments (including water butts, site layout and management, pervious pavements, filter drains, swales, filter strips, ponds, wetlands, soakaways, infiltration trenches and basins, green roofs, bioretention areas and stormwater pre-treatment devices, including sand filters or silt removal devices 10 ) and other innovative systems.

    The activity does not include nature-based solutions for flood and drought risk prevention and protection outside the urban environment (see Section 3.1. of this Annex).

    The economic activities in this category could be associated with several NACE codes, in particular E36.00, E37.00 and F42.9 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the sustainable use and protection of water and marine resources

    The activity leads to a retention of rainwater in a specific area or to an improvement in water quality by complying with the following criteria:

    (a)the construction and operation of the sustainable urban drainage system is integrated in the urban drainage and waste water treatment system, as demonstrated by means of a flood risk management plan or of other relevant urban planning tools. The activity contributes substantially to achieving the good status and good ecological potential of bodies of surface water and groundwater or to preventing the deterioration of bodies of water that already have good status and good potential, and is carried out to ensure compliance with Directive 2000/60/EC 11 and Directive 2008/56/EC;

    (b)information is provided on the percentage of a specific area, such as a residential or commercial area, where rainwater is not directly drained but retained within the area site;

    (c)the design of the sustainable urban drainage system achieves at least one of the following effects:

    (i)a quantified percentage of rainwater in the catchment area of the drainage system is retained and discharged with a staggered delay to the receiving water bodies;

    (ii)a quantified percentage of pollutants, including oil, heavy metals, hazardous chemicals and microplastics, is removed from urban runoff before discharge to the receiving water bodies;

    (iii)runoff peak flow, with a return period in line with the requirements of flood risk management plans or other local provisions in place, is reduced by a quantified percentage.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (4) Transition to a circular economy

    N/A

    (5) Pollution prevention and control

    Depending on the origin of the received water and the different pollutant load, such as rainwater, rainfall run-offs from roofs, rainfall run-offs from roads, or stormwater, SUDS treat these waters before discharging or infiltrating the water into other environmental media.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    The introduction of invasive alien species is prevented or their spread is managed in accordance with Regulation (EU) No 1143/2014 of the European Parliament and of the Council 12 .

    3.Disaster risk management  

    3.1.Nature-based solutions for flood and drought risk prevention and protection

    Description of the activity

    Planning, construction, extension, and operation of large-scale nature-based flood or drought management and coastal, transitional or inland aquatic ecosystem restoration measures contributing to preventing and protecting against flooding or droughts, and enhancing natural water retention, biodiversity and water quality.

    These large-scale nature-based flood or drought management measures are applied in peri-urban, rural and coastal areas and are coordinated at river basin, regional or local, such as municipal, scale.

    The economic activity includes:

    (a)river or lake related measures, including:

    (i)riparian or floodplain vegetation development or floodplain restoration, including re-connection of a river or lake with its floodplain or off-channel/lateral connectivity improvement to restore the retention capacity of the floodplain and its ecosystem’s function;

    (ii)re-meandering river courses by creating a new meandering course or reconnecting cut-off meanders or reconnecting a lake or group of lakes to a river;

    (iii)restoration of the longitudinal and lateral connectivity of a river (including oxbow lakes) by removing obsolete barriers, including dams and weirs or small barriers across or along the river;

    (iv)substitution of artificial riverbank or lake shore protection with nature-based solutions for bank or bed stabilisation as measures for river or lake restoration;

    (v)measures aimed to improve the diversification of river or lake depth and width to increase habitat variety.

    (b)wetland measures, including:

    (i)installation of ditches for rewetting, removal of drainage installations, replacement with installations that control the discharge, or setting back of dykes to enable flooding;

    (ii)implementation of constructed wetlands for water retention and treatment, both on land and along unvegetated water bodies, in rural and urban contexts;

    (iii)detention basins and retention ponds.

    (c)coastal measures, including:

    (i)conservation or restoration of coastal wetlands including mangrove forests or seagrass beds, which operate as a natural barrier;

    (ii)measures consisting of morphological changes and the removal of barriers to minimise the need of artificial beach nourishment and enhance the conditions of coastal ecosystems, justified on the basis of a sediment balance study;

    (iii)dune reinforcement and restoration, including the planting of dune vegetation;

    (iv)coastal reef conservation or restoration;

    (v)sand nourishments in the coastal zone.

    (d)river basin-wide management measures, including:

    (i)land management measures, including afforestation of reservoir catchments areas, spring or wellhead protection areas and river basin headwaters in general;

    (ii)restoration of natural infiltration for groundwater recharge by facilitating or augmenting soil retention capacity and infiltration;

    (iii)Managed Aquifer Recharge (MAR) 13 .

    The activity does not include small scale nature-based solutions to reduce flood and drought, including green and blue solutions applied in an urban setting, such as green roofs, swales, permeable surfaces and infiltration basins for urban storm water management purposes or Sustainable Urban Drainage Systems (see Section 2.3. of this Annex).

    The economic activities in this category could be associated with NACE code F42.91 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the sustainable use and protection of water and marine resources

    1. The activity is a quantifiable and time bound measure to achieve the objectives for flood risk reduction in accordance with a flood risk management plan coordinated at river basin scale and developed under Directive 2007/60/EC of the European Parliament and of the Council 14 . In relation to drought risk reduction, the activity is a quantifiable and time bound measure to achieve the objectives of Directive 2000/60/EC in accordance with a river basin management plan, or a drought management plan which is part of a river basin management plan.

    For activities in third countries, the activity is identified as a flood risk reduction or a drought risk reduction measure either in a water use and protection management plan at river basin scale or in an integrated coastal zone management plan along a coast. Those plans pursue the objectives for the management of flood and drought risks to reduce adverse consequences, where applicable for human health, the environment, cultural heritage and economic activity.

    2. Environmental degradation risks related to preserving water quality and avoiding water stress and preventing deterioration of the status of the affected water bodies are identified and addressed to achieve good water status and good ecological potential as defined in Article 2, points (22) and (23), of Regulation (EU) 2020/852, in accordance with Directive 2000/60/EC, and in line with a river basin management plan, developed thereunder for the potentially affected water body or bodies, in consultation with relevant stakeholders.

    Environmental degradation risks related to preserving marine environment are identified and addressed with the aim of achieving or maintaining good environmental status as defined in point 5 of Article 3 of Directive 2008/56/EC.

    3. The activity includes nature restoration or conservation actions that demonstrate specific ecosystem co-benefits, which contribute to achieving good water status or potential in accordance with Directive 2000/60/EC, good environmental status in accordance with Directive 2008/56/EC, and the nature restoration and conservation targets specified in the Communication from the Commission of 20 May 2020 on ‘EU Biodiversity Strategy for 2030’ 15 . The activity contains clear and binding targets on nature restoration or conservation over a clearly defined timeframe and describes measures to achieve those targets. Local stakeholders are involved from the outset in the planning and design phase. The activity is based on the principles outlined by the IUCN Global Standard for nature-based solutions.

    For activities in third countries, the activity takes into account National Biodiversity Strategies and Action Plans for the setting of nature conservation and restoration targets and for the description of the measures to achieve these targets.

    4. A monitoring programme is in place to evaluate the effectiveness of a nature-based solution scheme in improving the status of the affected water body, achieving the conservation and restoration targets and in adapting to changing climate conditions. The programme is reviewed following the periodic approach of the river basin management plans (including drought management plans, where relevant) and the flood risk management plans.

    For activities in third countries, the programme is reviewed at least once per programming period and in any case every 10 years. The programme adheres to and aligns with the prevailing legal and regulatory provisions, being clear on where legal responsibilities and liabilities lie. The programme actively engages local communities and other affected stakeholders.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    The activity does not involve the degradation of land and marine environment with high carbon stock 16 .

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (4) Transition to a circular economy

    Operators limit waste generation in processes related to construction and demolition and take into account best available techniques. At least 70 % (by weight) of the non-hazardous construction and demolition waste (excluding naturally occurring material referred to in category 17 05 04 in the European List of Waste established by Decision 2000/532/EC) generated on the construction site is prepared for reuse, recycling and other material recovery, including backfilling operations using waste to substitute other materials, in accordance with the waste hierarchy and the EU Construction and Demolition Waste Management Protocol 17 . Operators use selective demolition to enable removal and safe handling of hazardous substances and facilitate reuse and high-quality recycling.

    (5) Pollution prevention and control

    The use of pesticides is minimised and alternative approaches or techniques, which may include non-chemical alternatives to pesticides, are favoured, in accordance with Directive 2009/128/EC of the European Parliament and of the Council 18 , with exception of occasions where the use of pesticides is needed to control outbreaks of pest and diseases. The activity minimises the use of fertilisers and does not use manure.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    In addition, the following is to be ensured:

    (a)in the EU, in relation with Natura 2000 sites: the activity does not have significant effects on Natura 2000 sites in view of their conservation objectives on the basis of an appropriate assessment carried out in accordance with Article 6(3) of Council Directive 92/43/EEC 19 ;

    (b)in the EU, in any area: the activity is not detrimental to the recovery or maintenance of the populations of species protected under Directive 92/43/EEC and Directive 2009/147/EC of the European Parliament and of the Council 20 at a favourable conservation status. The activity is also not detrimental to the recovery or maintenance of the habitat types concerned and protected under Directive 92/43/EEC at a favourable conservation status;

    (c)in the EU, the introduction of invasive alien species is prevented, or their spread is managed in accordance with Regulation (EU) No 1143/2014;

    (d)outside of the EU, activities are conducted in accordance with applicable law related to the conservation of habitats, species and the management of invasive alien species.

    4.Information and communication 

    4.1.Provision of IT/OT data-driven solutions for leakage reduction

    Description of the activity

    The activity manufactures, develops, installs, deploys, maintains, repairs or provides professional services, including technical consulting for design or monitoring, for information technology (IT) or operational technology (OT) data driven solutions 21 to control, manage, reduce and mitigate leakage in water supply systems (WSSs).

    The economic activities in this category could be associated with several NACE codes, in particular E36, F42.99 and J62 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    An economic activity in this category is an enabling activity in accordance with Article 12(1), point (e), of Regulation (EU) 2020/852 where it complies with the technical screening criteria set out in this Section.

    Technical screening criteria

    Substantial contribution to the sustainable use and protection of water and marine resources

    1. The economic activity manufactures, develops, installs, deploys, maintains, repairs or provides professional services, including technical consulting for design or monitoring, to one or more of the following IT/OT data-driven solutions to control, manage, reduce and mitigate leakage in the new or existing water supply systems:

    (a)monitoring systems including holistic IT/OT suites/tools, or add-ons/extensions to such tools that provide identification, tracking and tracing water leakage;

    (b)IT/OT solutions, or add-ons/extensions to such tools, that provide controlling, managing and mitigating water leakage;

    (c)IT/OT solutions, or add-ons/extensions to such tools, that ensure interoperability of systems in district metered areas when new monitoring systems or IT/OT solutions are installed.

    2. Environmental degradation risks related to preserving water quality and avoiding water stress are identified and addressed to achieve good water status and good ecological potential as defined in Article 2, points (22) and (23), of Regulation (EU) 2020/852, in accordance with Directive 2000/60/EC 22 and in line with a water use and protection management plan, developed thereunder for the potentially affected water body or bodies, in consultation with relevant stakeholders.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (4) Transition to a circular economy

    Measures are in place to manage and recycle waste at the end-of life, including through decommissioning contractual agreements with recycling service providers, reflection in financial projections or official project documentation. These measures ensure that components and materials are segregated and treated to maximise recycling and reuse in accordance with the waste hierarchy, EU waste regulation principles and applicable regulations, in particular through the reuse and recycling of batteries and electronics and the critical raw materials therein. These measures also include the control and management of hazardous materials.

    Preparation for re-use, recovery or recycling operations, or proper treatment, including the removal of all fluids and a selective treatment are performed in accordance with Annex VII to Directive 2012/19/EU of the European Parliament and of the Council 23 .

    (5) Pollution prevention and control

    The equipment used meets the requirements laid down in Directive 2009/125/EC of the European Parliament and of the Council 24  for servers and data storage products.

    The equipment used does not contain the restricted substances listed in Annex II to Directive 2011/65/EU of the European Parliament and of the Council 25 , except where the concentration values by weight in homogeneous materials do not exceed the maximum values listed in that Annex.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A



    Appendix A: Generic criteria for DNSH to climate change adaptation

    I. Criteria

    The physical climate risks that are material to the activity have been identified from those listed in the table in Section II of this Appendix by performing a robust climate risk and vulnerability assessment with the following steps:

    (a)    screening of the activity to identify which physical climate risks from the list in Section II of this Appendix may affect the performance of the economic activity during its expected lifetime;

    (b)    where the activity is assessed to be at risk from one or more of the physical climate risks listed in Section II of this Appendix, a climate risk and vulnerability assessment to assess the materiality of the physical climate risks on the economic activity;

    (c)    an assessment of adaptation solutions that can reduce the identified physical climate risk.

    The climate risk and vulnerability assessment is proportionate to the scale of the activity and its expected lifespan, such that:

    (a)    for activities with an expected lifespan of less than 10 years, the assessment is performed, at least by using climate projections at the smallest appropriate scale;

    (b)    for all other activities, the assessment is performed using the highest available resolution, state-of-the-art climate projections across the existing range of future scenarios 26 consistent with the expected lifetime of the activity, including, at least, 10 to 30 year climate projections scenarios for major investments.

    The climate projections and assessment of impacts are based on best practice and available guidance and take into account the state-of-the-art science for vulnerability and risk analysis and related methodologies in line with the most recent Intergovernmental Panel on Climate Change reports 27 , scientific peer-reviewed publications, and open source 28 or paying models.

    For existing activities and new activities using existing physical assets, the economic operator implements physical and non-physical solutions (‘adaptation solutions’), over a period of time of up to five years, that reduce the most important identified physical climate risks that are material to that activity. An adaptation plan for the implementation of those solutions is drawn up accordingly.

    For new activities and existing activities using newly-built physical assets, the economic operator integrates the adaptation solutions that reduce the most important identified physical climate risks that are material to that activity at the time of design and construction and has implemented them before the start of operations.

    The adaptation solutions implemented do not adversely affect the adaptation efforts or the level of resilience to physical climate risks of other people, of nature, of cultural heritage, of assets and of other economic activities; are consistent with local, sectoral, regional or national adaptation strategies and plans; and consider the use of nature-based solutions 29 or rely on blue or green infrastructure 30 to the extent possible.

    II. Classification of climate-related hazards 31

    Temperature-related

    Wind-related

    Water-related

    Solid mass-related

    Chronic

    Changing temperature (air, freshwater, marine water)

    Changing wind patterns

    Changing precipitation patterns and types (rain, hail, snow/ice)

    Coastal erosion

    Heat stress

    Precipitation or hydrological variability

    Soil degradation

    Temperature variability

    Ocean acidification

    Soil erosion

    Permafrost thawing

    Saline intrusion

    Solifluction

    Sea level rise

    Water stress

    Acute

    Heat wave

    Cyclone, hurricane, typhoon

    Drought

    Avalanche

    Cold wave/frost

    Storm (including blizzards, dust and sandstorms)

    Heavy precipitation (rain, hail, snow/ice)

    Landslide

    Wildfire

    Tornado

    Flood (coastal, fluvial, pluvial, ground water)

    Subsidence

    Glacial lake outburst



    Appendix C: Generic criteria for DNSH to pollution prevention and control regarding use and presence of chemicals

    The activity does not lead to the manufacture, placing on the market or use of:

    (a) substances, whether on their own, in mixtures or in articles, listed in Annexes I or II to Regulation (EU) 2019/1021 of the European Parliament and of the Council 32 , except in the case of substances present as an unintentional trace contaminant;

    (b) mercury and mercury compounds, their mixtures and mercury-added products as defined in Article 2 of Regulation (EU) 2017/852 of the European Parliament and of the Council 33 ;

    (c) substances, whether on their own, in mixture or in articles, listed in Annexes I or II to Regulation (EC) No 1005/2009 of the European Parliament and of the Council 34 ;

    (d) substances, whether on their own, in mixtures or in articles, listed in Annex II to Directive 2011/65/EU, except where there is full compliance with Article 4(1) of that Directive;

    (e) substances, whether on their own, in mixtures or in an article, listed in Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council 35 , except where there is full compliance with the conditions specified in that Annex;

    (f) substances, whether on their own, or in mixtures or in an article, in a concentration above 0,1% weight by weight (w/w), and meeting the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 and that were identified in accordance with Article 59(1) of that Regulation for a period of at least 18 months, except if it is assessed and documented by the operators that no other suitable alternative substances or technologies are available on the market, and that they are used under controlled conditions 36

    In addition, the activity does not lead to the manufacture, presence in the final product or output, or placing on the market, of other substances, whether on their own, or in mixtures or in an article, in a concentration above 0,1% weight by weight (w/w), that meet the criteria of Regulation (EC) No 1272/2008 for one of the hazard classes or hazard categories mentioned in Article 57 of Regulation (EC) No 1907/2006, except if it is assessed and documented by the operators that no other suitable alternative substances or technologies are available on the market, and that they are used under controlled conditions 37 .



    Appendix D: Generic criteria for DNSH to protection and restoration of biodiversity and ecosystems

    An Environmental Impact Assessment (EIA) or screening 38 has been completed in accordance with Directive 2011/92/EU 39 .

    Where an EIA has been carried out, the required mitigation and compensation measures for protecting the environment are implemented.

    For sites/operations located in or near biodiversity-sensitive areas (including the Natura 2000 network of protected areas, UNESCO World Heritage sites and Key Biodiversity Areas, as well as other protected areas), an appropriate assessment 40 , where applicable, has been conducted and based on its conclusions the necessary mitigation measures 41 are implemented.

    (1)    For activities in third countries, in accordance with applicable national law or international standards which pursue equivalent objectives of good water status and good ecological potential, through equivalent procedural and substantive rules, i.e. a water use and protection management plan developed in consultation with relevant stakeholders which ensures that 1) the impact of the activities on the identified status or ecological potential of potentially affected water body or bodies is assessed and 2) deterioration or prevention of good status/ecological potential is avoided.
    (2)    Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1).
    (3)    Commission Implementing Decision (EU) 2022/679 of 19 January 2022 establishing a watch list of substances and compounds of concern for water intended for human consumption as provided for in Directive (EU) 2020/2184 of the European Parliament and of the Council (OJ L 124, 27.4.2022, p. 41).
    (4)    The Infrastructure Leakage Index (ILI) is calculated as current annual real losses (CARL)/unavoidable annual real losses (UARL). The current annual real losses (CARL) represent the amount of water that is actually lost from the distribution network (i.e., not delivered to final users). The unavoidable annual real losses (UARL) take into consideration that there will always be some leakage in a water distribution network. The UARL is calculated based on factors such as the length of the network, the number of service connections and the pressure at which the network is operating.
    (5)    For activities in third countries, in accordance with applicable national law or international standards which pursue equivalent objectives of good water status and good ecological potential, through equivalent procedural and substantive rules, i.e. a water use and protection management plan developed in consultation with relevant stakeholders which ensures that 1) the impact of the activities on the identified status or ecological potential of potentially affected water body or bodies is assessed and 2) deterioration or prevention of good status/ecological potential is avoided.
    (6)    For activities in third countries, in accordance with applicable national law or international standards which pursue equivalent objectives of good water status and good ecological potential, through equivalent procedural and substantive rules, i.e. a water use and protection management plan developed in consultation with relevant stakeholders which ensures that 1) the impact of the activities on the identified status or ecological potential of potentially affected water body or bodies is assessed and 2) deterioration or prevention of good status/ecological potential is avoided.
    (7)    Population equivalent (p.e.) means the organic biodegradable load having a five-day biochemical oxygen demand (BOD5) of 60 g of oxygen per day.
    (8)    For example, in line with IPCC guidelines for national GHG inventories for waste water treatment,  version of [adoption date] available at https://www.ipcc-nggip.iges.or.jp/public/2019rf/pdf/5_Volume5/19R_V5_6_Ch06_Wastewater.pdf.
    (9)    Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.1986, p. 6).
    (10)    As defined in the document JRC Publications Repository - Best Environmental Management Practice for the Public Administration Sector (europa.eu).
    (11)    For activities in third countries, in accordance with applicable national law or international standards which pursue equivalent objectives of good water status and good ecological potential, through equivalent procedural and substantive rules, i.e. a water use and protection management plan, developed in consultation with relevant stakeholders which ensures that 1) the impact of the activities on the identified status or ecological potential of potentially affected water body or bodies is assessed and 2) deterioration or prevention of good status/ecological potential is avoided.
    (12)    Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35).
    (13)    Managed Aquifer Recharge is ‘the process of intentionally recharging an aquifer with water from a different place for subsequent recovery or for environmental benefits’.
    (14)    Directive 2007/60/EC of the European Parliament and of the Council of 23 October 2007 on the assessment and management of flood risks (OJ L 288, 6.11.2007, p. 27–34).
    (15)    Communication from the Commission of 20 May 2020 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions EU Biodiversity Strategy for 2030 Bringing nature back into our lives, COM/2020/380 final.
    (16)    Land with high-carbon stock means wetlands, including peatland, and continuously forested areas within the meaning of Article 29(4)(a), (b) and (c) of Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82-209).
    (17)    EU Construction & Demolition Waste Management Protocol, September 2016: https://ec.europa.eu/docsroom/documents/20509/.
    (18)    Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).
    (19)    Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
    (20)    Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7).
    (21)    ‘IT or OT data-driven solutions’ include connectable products, sensors, analytics and other software, and information and communication technologies (ICT) for the transmission, storage and display of data and system management.
    (22)    For activities in third countries, in accordance with applicable national law or international standards which pursue equivalent objectives of good water status and good ecological potential, through equivalent procedural and substantive rules, i.e. a water use and protection management plan developed in consultation with relevant stakeholders which ensures that 1) the impact of the activities on the identified status or ecological potential of potentially affected water body or bodies is assessed and 2) deterioration or prevention of good status/ecological potential is avoided.
    (23)    Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) (recast) (OJ L 197, 24.7.2012, p. 38).
    (24)    Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (recast) (OJ L 285, 31.10.2009, p. 10).
    (25)    Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. (OJ L 174, 1.7.2011, p. 88).
    (26)    Future scenarios include Intergovernmental Panel on Climate Change representative concentration pathways RCP2.6, RCP4.5, RCP6.0 and RCP8.5.
    (27)    Assessments Reports on Climate Change: Impacts, Adaptation and Vulnerability, published periodically by the Intergovernmental Panel on Climate Change (IPCC), the United Nations body for assessing the science related to climate change produces, https://www.ipcc.ch/reports/.
    (28)    Such as Copernicus services managed by the European Commission.
    (29)    Nature-based solutions are defined as ‘solutions that are inspired and supported by nature, which are cost-effective, simultaneously provide environmental, social and economic benefits and help build resilience. Such solutions bring more, and more diverse, nature and natural features and processes into cities, landscapes and seascapes, through locally adapted, resource-efficient and systemic interventions’. Therefore, nature-based solutions benefit biodiversity and support the delivery of a range of ecosystem services. (version of [adoption date]: https://ec.europa.eu/research/environment/index.cfm?pg=nbs ).
    (30)    See Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Green Infrastructure (GI) — Enhancing Europe’s Natural Capital (COM/2013/0249 final).
    (31)    The list of climate-related hazards in this table is non-exhaustive, and constitutes only an indicative list of most widespread hazards that are to be taken into account as a minimum in the climate risk and vulnerability assessment.
    (32)    Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45).
    (33)    Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1).
    (34)    Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1).
    (35)    Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. (OJ L 396, 30.12.2006, p. 1).
    (36)    The Commission will review the exceptions from the prohibition from manufacturing, placing on the market or use of the substances referred to in point (f) once it will have published horizontal principles on essential use of chemicals.
    (37)    The Commission will review the exceptions from the prohibition from manufacture, presence in the final product or output, or placing on the market of the substances referred to in this paragraph once it will have published horizontal principles on essential use of chemicals.
    (38)    The procedure through which the competent authority determines whether projects listed in Annex II to Directive 2011/92/EU is to be made subject to an environmental impact assessment (as referred to in Article 4(2) of that Directive).
    (39)    For activities in third countries, in accordance with equivalent applicable national law or international standards requiring the completion of an EIA or screening, for example, IFC Performance Standard 1: Assessment and Management of Environmental and Social Risks.
    (40)    In accordance with Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7) and Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). For activities located in third countries, in accordance with equivalent applicable national law or international standards, that aim at the conservation of natural habitats, wild fauna and wild flora, and that require to carry out (1) a screening procedure to determine whether, for a given activity, an appropriate assessment of the possible impacts on protected habitats and species is needed; (2) such an appropriate assessment where the screening determines that it is needed, for example IFC Performance Standard 6: Biodiversity Conservation and Sustainable Management of Living Natural Resources.
    (41)    Those measures have been identified to ensure that the project, plan or activity will not have any significant effects on the conservation objectives of the protected area.
    Top

    TABLE OF CONTENTS

    ANNEX II    2

    1.Manufacturing2

    1.1.Manufacture of plastic packaging goods 2

    1.2.Manufacture of electrical and electronic equipment7

    2.Water supply, sewerage, waste management and remediation activities 16

    2.1.Phosphorus recovery from waste water16

    2.2.Production of alternative water resources for purposes other than human consumption17

    2.3.Collection and transport of non-hazardous and hazardous waste 19

    2.4.Treatment of hazardous waste 22

    2.5.Recovery of bio-waste by anaerobic digestion or composting 25

    2.6.Depollution and dismantling of end-of-life products27

    2.7.Sorting and material recovery of non-hazardous waste30

    3.Construction and real estate activities 32

    3.1.Construction of new buildings 32

    3.2.Renovation of existing buildings37

    3.3.Demolition and wrecking of buildings and other structures41

    3.4.Maintenance of roads and motorways44

    3.5.Use of concrete in civil engineering 46

    4.Information and communication50

    4.1.Provision of IT/OT data-driven solutions 50

    5.Services 55

    5.1.Repair, refurbishment and remanufacturing55

    5.2.Sale of spare parts58

    5.3.Preparation for re-use of end-of-life products and product components60

    5.4.Sale of second-hand goods63

    5.5.Product-as-a-service and other circular use- and result-oriented service models67

    5.6.Marketplace for the trade of second-hand goods for reuse69

    ANNEX II

    Technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the transition to a circular economy and for determining whether that economic activity causes no significant harm to any of the other environmental objectives

    1.Manufacturing

    1.1.Manufacture of plastic packaging goods 

    Description of the activity

    Manufacture of plastic packaging goods.

    The economic activities in this category could be associated with NACE code C22.22 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The activity complies with one of the following criteria:

    (a)use of circular feedstock: until 2028, at least 35% of the packaging product by weight consists of recycled post-consumer material for non-contact sensitive packaging and at least 10% for contact sensitive packaging 1 . From 2028, at least 65% of the packaging product by weight consists of recycled post-consumer material for non-contact sensitive packaging and at least 50% for contact sensitive packaging;

    (b)design for reuse: the packaging product has been designed to be reusable within a reuse system 2  and fulfils the requirements for the use of circular feedstock, as set in point 1.a with 35% and 10% targets for recycled feedstock applying as of 2028 and 65% and 50% targets applying as of 2032. The system for reuse is established in a way that ensures the possibility of reuse in a closed-loop or open-loop system which:

    (i)provides a defined governance structure and keeps records on the number of fillings, re-uses, rejects, collection rate, amount of reusable packaging placed on the market and units of sales or equivalent units;

    (ii)provides rules on the product scope and packaging formats, as well as on the collection of reusable packaging, including incentives for consumers;

    (iii)ensures open and equal access and conditions for all economic operators wishing to become part of it, including proporitionate distribution of costs and benefits for all system participants 3 ;

    (a)use of bio-waste feedstock: at least 65% of the packaging product by weight consists of sustainable bio-waste feedstock 4 . Agricultural based bio-waste used for the manufacture of plastic packaging complies with the criteria laid down in Article 29, paragraphs 2 to 5, of Directive (EU) 2018/2001. Forest based bio-waste used for the manufacture of plastic packaging complies with the criteria laid down in Article 29, paragraphs 6 and 7, of that Directive.

    2. The packaging product is recyclable in practice and at scale. The packaging product demonstrates recyclability in practice and at scale by complying with all of the criteria specified below 5 .

    2.1. The unit of packaging 6 is designed to be recyclable, so that it can be sorted and recycled at the end of life and that the resulting recycled material is of such quality that it can be used again in packaging applications. Colours, additives or design elements of the packaging that contaminate the recycling stream once packaging becomes waste and substantially reduce the quality of the resulting recyclates are not used. At best, the unit of packaging is made from the same material (mono-material solution) or, as a minimum, the materials present in the packaging are compatible with the existing recycling streams and sorting processes. Where all packaging components are not compatible with the existing recycling streams and processes, the packaging must allow for separation of its non-recyclable components, either manually by consumers or within the existing sorting and recycling processes.

    2.2. In addition, the packaging is evaluated as recyclable at scale where it complies with one of the following criteria:

    (a)collection, sorting, and recycling is proven to work in practice and at scale: the plastic packaging material of the unit of packaging achieves the minimum recycling rate 7  target for plastic packaging waste set by the Directive 94/62/EC, either in the national jurisdiction where the packaging is put on the market, regardless of the jurisdiction’s size, or in Member States that collectively represent at least 100 million inhabitants;

    (b)collection, sorting, and recycling is proven to be on track to work in practice and at scale: sorting and recycling processes are available at the Technology Readiness of Level 9 as defined by ISO 16290:2013 8 .

    3. When the packaging material is produced, the following substances presenting hazardous properties specified below are not added to the feedstock:

    (a)substances meeting the criteria laid down in Article 57 and identified in accordance with Article 59(1) of Regulation (EC) No 1907/2006;

    (b)substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and the Council 9 ;

    (c)substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Regulation (EC) No 1272/2008;

    (d)substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in accordance with Regulation (EC) No 1272/2008;

    (e)substances meeting the criteria for classification as endocrine disruption for human health category 1 or as endocrine disruption for environment category 1 in accordance with Regulation (EC) No 1272/2008;

    (f)substances meeting the criteria for classification as persistent, bioaccumulative and toxic in accordance with Regulation (EC) No 1272/2008;

    (g)substances meeting the criteria for classification as very persistent and very bioacumulative in accordance with Regulation (EC) No 1272/2008;

    (h)substances meeting the criteria for classification as persistent, mobile and toxic in accordance with Regulation (EC) No 1272/2008;

    (i)substances meeting the criteria for classification as very persistent and very mobile in accordance with Regulation (EC) No 1272/2008;

    (j)substances meeting the criteria for classification as respiratory sensitiser category 1 in accordance with Regulation (EC) No 1272/2008, except enzymes;

    (k)substances meeting the criteria for classification as skin sensitiser category 1 in accordance with Regulation (EC) No 1272/2008;

    (a)substances meeting the criteria for classification as having chronic hazard to the aquatic environment category 1, 2, 3 or 4 in accordance with Regulation (EC) No 1272/2008;

    (m)substances meeting the criteria for classification as hazardous to the ozone layer in accordance with Regulation (EC) No 1272/2008;

    (n)substances meeting the criteria for classification as having specific target organ toxicity – repeated exposure category 1 or 2 in accordance with Regulation (EC) No 1272/2008;

    (o)substances meeting the criteria for classification as having specific target organ toxicity – single exposure category 1 or 2 in accordance with Regulation (EC) No 1272/2008.

    4. Compostable plastic materials in packaging applications are used only for very lightweight plastic carrier bags; tea, coffee or other beverage bags; tea, coffee or other beverage pads and sticky labels attached to fruit and vegetables.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    For plastic manufactured from chemical recycled feedstock, life-cycle GHG emissions of the manufactured plastic, excluding any calculated credits from the production of fuels, are lower than the life-cycle GHG emissions of the equivalent plastic in primary form manufactured from fossil fuel feedstock. Life-cycle GHG emissions are calculated using Commission Recommendation 2021/2279/EU 10 or, alternatively, using ISO 14067:2018 11 or ISO 14064-1:2018 12 . Quantified life-cycle GHG emissions are verified by an independent third party.

    Life-cycle GHG emissions of plastic manufactured from sustainable bio-waste feedstock are lower than the life-cycle GHG emissions of the equivalent plastics in primary form manufactured from fossil fuel feedstock. Life-cycle GHG emissions are calculated using Recommendation 2013/179/EU or, alternatively, using ISO 14067:2018 or ISO 14064-1:2018. Quantified life-cycle GHG emissions are verified by an independent third party.

    (2) Climate change adaptation

    The activity complies with criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The activity complies with criteria set out in Appendix C to this Annex.

    For the products manufactured from plastic materials in primary form, emissions from the manufacturing of those plastic materials are within or lower than the emission levels associated with the best available techniques (BAT-AEL) ranges set out in the relevant best available techniques (BAT) conclusions, including:

    (a)the best available techniques (BAT) conclusions for common waste water and waste gas treatment/management systems in the chemical sector 13 , for emissions to water where relevant emission thresholds apply;

    (a)the best available techniques (BAT) conclusions for common waste gas management and treatment systems in the chemical sector 14  for emissions to air of new installations (or for existing installations within 4 years of the BATC publication) where relevant conditions apply;

    (c)the Best Available Techniques Reference Document (BREF) for the Production of Polymers 15  for the production processes under conditions not covered by the BATC mentioned above;

    (d)the Best Available Techniques Reference Document (BREF) for the Large Volume Inorganic Chemicals – Solids and Others industry 16 ;

    (e)the Best Available Techniques Reference Document (BREF) for the manufacture of Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers 17 ;

    (f)the Best Available Techniques Reference Document (BREF) for Manufacture of Organic Fine Chemicals 18 ;

    (g)the Best Available Techniques Reference Document (BREF) for the production of speciality inorganic chemicals (SIC) 19 .

    No significant cross-media effects occur.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with criteria set out in Appendix D to this Annex.

    1.2.Manufacture of electrical and electronic equipment

    Description of the activity

    Manufacturing of electrical and electronic equipment for industrial, professional and consumer use.

    This activity includes manufacturing of rechargeable and non-rechargeable portable batteries 20 . The activity does not include manufacturing of other battery categories.

    The economic activities in this category could be associated with several NACE codes, in particular C26 and C27 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. Where the economic activity manufactures electrical and electronic equipment complying with all EU Ecolabel criteria applicable to that specific product category, in accordance with Regulation (EC) 66/2010 of the European Parliament and of the Council 21 , the operator of the activity provides the proof of compliance with all requirements listed, in accordance with the verification criteria foreseen by the EU Ecolabel criteria. 

    2. Where no product specific EU Ecolabel criteria exist, or the operator of the activity has not used them, the economic activity manufacturing electrical and electronic equipment complies with all of the following criteria applicable to a relevant product:

    2.1. Design for long lifetime

    2.1.1. Where the product contains software that requires updates, all versions of software components, software support and software/firmware, including updates, are made available to users for the lifetime of an item as defined under Directive 2009/125/EC and implementing acts adopted under that Directive. Where the availability of software updates is not regulated, the availability is at least eight years. Functionality and lifetime of the product are not reduced through software updates or lack of software updates.

    2.1.2. Products incorporating portable batteries ensure that those batteries are readily removable and replaceable by the end-user at any time during the lifetime of the product, without requiring the use of specialised tools (unless the tools are provided free of charge with the product), proprietary tools, thermal energy, or solvents to disassemble, except when batteries are designed in such way to make battery removable and replaceable only by independent professionals in the following case:

    (a)appliances specifically designed to operate primarily in an environment that is regularly subject to splashing water, water streams or water immersion and that are intended to be washable or rinseable and where it is required to ensure the safety of the user and the appliance;

    (b)professional medical imaging and radiotherapy devices, as defined in Article 2(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council 22 , and in-vitro diagnostic medical devices, as defined in Article 2(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council 23 ;

    (c)where continuity of power supply is necessary and a permanent connection between the product and the respective portable battery is required to ensure the safety of the user and of the appliance or, for products that collect and supply data as their main function, for data integrity reasons.

    2.1.3. Software is not used in order to negatively affect the circularity of the product, including replacement of a portable battery, and correct battery replacement does not degrade the functioning of the product.

    2.2. Design for repair and guarantee

    2.2.1 Where a product specific repair scoring systems is established in accordance with the Union Law, the operator of the activity ensures that products have the highest populated reparability class 24 .

    2.2.2.  The operator of the activity provides access to information to professional repairers 25  throughout the lifetime of the product. The information includes the following elements, where applicable:

    (a)the unequivocal appliance identification;

    (b)a disassembly map or exploded view;

    (c)list of necessary repair and test equipment;

    (d)technical details of the components and diagnosis information, such as minimum and maximum theoretical values for measurements;

    (e)wiring and connection diagrams;

    (f)diagnostic fault and error codes, including manufacturer-specific codes;

    (g)data records of reported failure incidents stored on the product;

    (h)technical manual of instructions for repair of the product, including simple electronic board diagrams, that includes marking of the individual steps;

    (i)instructions for software and firmware, including reset software;

    (j)information on how to access data records of reported failure incidents stored on the device, where applicable, with the exception of personal identifiable information such as related to user behaviour and location information.

    2.2.3. Key spare parts 26 , whether new or used, such as motors, batteries, circuit boards and any part or component essential to the good functioning of the product, are available to professional repairers and end-users, after placing the last unit of the model on the market, for one additional year compared to the requirements on the availability of spare parts under Directive 2009/125/EC and implementing acts adopted under that Directive. Where the availability of spare parts for the relevant products is not regulated, key spare parts are available for at least eight years after placing the last unit of the model on the market.

    2.2.4. Where there are no significant health and safety risks presented by the product repair, the operator of the activity provides clear disassembly and repair instructions, including through hard or soft copy or a video, and make them publicly available for the lifetime of the product, to enable a non-destructive disassembly of products for the purpose of replacing key components or parts for upgrades or repairs. Where significant safety concerns connected to the repair of the product exist, the operator ensures access to independent certified professional repairers. The operator’s website indicates the process for professional repairers to register for access to relevant information or share the information on a publicly available free access website.

    2.2.5. For electrical and electronic equipment designed for consumer use, the operator of the activity provides commercial guarantee for minimum of 3 years and in line with requirements under Article 17 of Directive 2019/771/EU of the European Parliament and of the Council 27  at no extra cost.

    2.3. Design for reuse and remanufacturing

    2.3.1. Where the products are able to store data, and the data is encrypted, a software function that resets the device to its factory settings and erases by default the encryption key is required.

    2.3.2. Where products can transfer stored data, the stored data can be easily and fully transferred to another product, securing data privacy and confidentiality of the data.

    2.4. Design for dismantling

    2.4.1. Information on product’s end of life management is publicly available for the lifetime of the product, including all information required under Directive 2012/19/EU. For each type of new product placed for the first time on the Union market, the operator of the activity shares, free of charge, relevant information with centres which prepare for re-use and treatment and recycling facilities through Information for Recyclers Platform 28 or through another relevant channel in accordance with Article 15(1) of Directive 2012/19/EU. Dismantling information includes the sequence of dismantling steps, tools or technologies needed to access the targeted component.

    2.4.2. For electrical and electronic equipment containing printed circuit boards, hard disc drives (HDDs), electric motors, permanent magnets, batteries, fluorescent powders, or any other components identified in Union legislation to be of high critical raw materials recovery potential, the information on product’s end of life management referred to under point 2.4.1 includes an indication of the critical raw materials 29 typically contained in the components, information on the location of those components, and on the steps required for their separate removal.

    2.4.3. The activity provides tracking information on substances identified as substance of very high concern (SVHC) and for substances meeting the criteria for substance of very high concern (SVHC), by complying with at least one of the two disclosure frameworks listed below:

    (a)product information on substances is available publicly, in SCIP database 30 for products that contain > 0.1% (w/w) of an identified substance of very high concern or in a specific public tool provided by company;

    (b)product information on substances is available publicly, following IEC62474 31 (for electrical and electronic equipment) and future IEC82474-1 32 (dual logo project).

    2.5. Design for recyclability

    The economic activity manufactures products with demonstrated superior recyclability. Assessment of recyclability relies on EN 45555:2019 33 or on any product-specific EN standard relying on EN 45555:2019. The economic activity complies with the following requirements:

    (a)single polymer or recyclable polymer blends are used;

    (b)plastic enclosures do not contain moulded-in or glue-on metal;

    (c)materials which cannot be recycled together are easy to access and have the ability to be separated;

    (d)improving recyclability does not harm the durability of the system itself;

    (e)parts of the product containing substances, mixtures and components that are to be removed during depollution are easy to identify, such as through marking for sorting provided by the manufacturer, and visible on the product;

    (f)printed circuit boards, hard disc drives (HDDs), electric motors, permanent magnets, batteries, fluorescent powders, or any other components identified in Union legislation to be of high critical raw materials recovery potential are easy to access and to remove from the product;

    (g)parts that reduce the recyclability according to the reference scenario for the end-of-life treatment of products, such as plastic using certain fillers or certain flame retardants, are easy to access and remove;

    (h)joining, fastening or sealing techniques do not prevent the safe and readily achievable removal of the components specified in Directive 2012/19/EU or in [OP: please insert reference to Regulation 2023/XXXX on batteries and waste batteries (based on Commission proposal COM/2020/798 34 )], where present.

    2.6. Proactive substitution of hazardous substances

    2.6.1. The economic activity manufactures products which demonstrate proactive substitution of hazardous substances.

    2.6.2. The product does not contain substances of very high concern included in Annex XIV to Regulation 1907/2006/EC.

    2.6.3. Exemptions to Restrictions of Hazardous Substances are limited to the following cases:

    (a)lead in high melting temperature type solders covered by the exemption entry 7(a) in Annex III to Directive 2011/65/EU;

    (b)electrical and electronic components containing lead in a glass or ceramic covered by the exemption entries under 7(c) in Annex III to Directive 2011/65/EU. 

    2.6.4. The hazardous substances specified in table below are not introduced to or formed in the specified sub-assemblies and component parts at or above the specified concentration limit.

    Substance group

    Scope of restriction

    Concentration limits (where applicable)

    i) Polymer stabilisers, colourants and contaminant

    The following organotin stabiliser compounds are not present in external cables:

    Dibutyltin oxide

    Dibutyltin diacetate

    Dibutyltin dilaurate

    Dibutyltin maleate

    Dioctyl tin oxide

    Dioctyl tin dilaurate

    External housing do not contain the following colourants: Azo dyes that may cleave to the carcinogenic aryl amines listed in Appendix 8 of the Regulation (EC) No 1907/2006, or Colourant compounds included in the IEC 62474 declarable substances list.

    N/A

    ii) Polymer stabilisers, colourants and contaminant

    Polycyclic Aromatic Hydrocarbons (PAHs) are not present at concentrations greater than or equal to individual and sum total concentration limits in any external plastic or man-made rubber surfaces.

    The presence and concentration of the following PAHs is verified:

    PAHs restricted by the Regulation (EC) No 1907/2006:

    Benzo[a]pyrene Benzo[e]pyrene

    Benzo[a]anthracene

    Chrysen

    Benzo[b]fluoranthene

    Benzo[j]fluoranthene

    Benzo[k]fluoranthene

    Dibenzo[a,h]anthracene

    Additional PAHs subject to restriction:

    Acenaphthene

    Acenaphthylene

    Anthracene

    Benzo[ghi]perylene

    Fluoranthene

    Fluorene

    Indeno[1,2,3-cd]pyrene

    Naphthalene

    Phenanthrene

    Pyrene

    The individual concentration limits for PAHs restricted under Regulation (EC) No 1907/2006 is 1 mg/kg

    The sum total concentration limit for the 18 listed PAHs is not greater than 10 mg/kg

    iii) Biocidal products

    Biocidal products intended to provide an anti-bacterial function

    Derogation for materials sold in hospitals and for healthcare applications

    N/A

    v) Glass fining agents

    Arsenic and its compounds is not used in the manufacturing of LCD display unit glass and screen cover glass.

    0,0050% w/w

    vi) Chlorine based plastics

    Plastic parts >25g do not contain chlorinated polymers.

    Note: For this specific sub-requirement, plastic cable housing is not considered as a ’plastic part’.

    N/A

    2.6.5. The products do not contain halogen beyond the limits which can be detected in line with the measurement specified in existing standards for all its components: cables (EN IEC 60754-3), plastic parts (EN50642), electronic components (EN IEC 61249-2-21 or JS709C), consumables (EN IEC 61249-2-21 and IPC J-STD-004B).

    2.6.6. The products do not contain fluor gas.

    2.6.7. Use of Tetrabromobisphenol A (TBBPA) is allowed as reactive component for Printed Circuit Boards only.

    2.7. Information to customers:

    2.7.1. The operator of the activity provides information to customers regarding options to use the product considering the environmental benefits, in particular the lifetime extension of the products associated with the different modes of the product.

    2.7.2. The operator of the activity provides information to customers regarding the buy-back, sell-back and take-back options for the product, information on separate collection and collection points for waste electrical and electronic equipment (WEEE), as well as information on re-use options. For portable batteries, information is provided on separate collection and collection points for waste batteries.

    2.7.3. For electrical and electronic equipment, the operator of the activity appropriately marks the product with the symbol indicating separate collection for waste electrical and electronic equipment as set out in Annex IX to the Directive 2012/19/EU. The operator of the activity provides the consumer with relevant information on costs of collection, treatment and disposal of the product in an environmentally sound way as set out in Article 14(1) of that Directive.

    2.8. Producer responsibility:

    2.8.1. The operator of the activity, when placing electrical and electronic equipment on the market of the Member States, establishes an individual extended producer responsibility scheme or participates in collective extended producer responsibility schemes in all the Member States in which the product is placed on the market, in line with Directive 2012/19/EU. The financial contributions to the collective schemes are based on eco modulation and cover the costs of separate collection and treatment of WEEE.

    2.8.2. For portable batteries, the producer establishes waste portable battery take-back and collection systems, which include collection points, in all Member States in which the product is placed on the market.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the manufactured product contains refrigerants, it complies with the GWP performance laid down in the Regulation (EU) No 517/2014 of the European Parliament and of the Council 35 . The activity does not manufacture products containing Sulfur hexafluoride (SF6).

    Where applicable, the manufactured product does not score lower than the third significantly populated class 36 of energy efficiency in accordance with Regulation (EU) 2017/1369 of the European Parliament and of the Council and delegated acts adopted under that Regulation 37 .

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The activity complies with criteria set out in Appendix C to this Annex.

    For manufacturing of portable batteries, batteries comply with the applicable sustainability rules on the placing on the market of batteries in the Union, including restrictions on the use of hazardous substances in batteries, including Regulation (EC) No 1907/2006 and Directive 2006/66/EC of the European Parliament and of the Council 38 .

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.Water supply, sewerage, waste management and remediation activities 

    2.1.Phosphorus recovery from waste water

    Description of the activity

    Construction, upgrade, operation and renewal of facilities for recovery of phosphorus from urban waste water treatment plants (WWTP) (aqueous phase and sludge) and from materials (i.e. ashes) after thermal oxidation (i.e. incineration) of sewage sludge.

    The economic activity only includes the facilities and processes that make phosphorus recovery possible, not the previous steps, such as waste water treatment or incineration facilities.

    The economic activities in this category could be associated with several NACE codes, in particular E37.00, E38.32 and F42.99 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. For the process integrated at the waste water treatment plant, covering typically phosphorus salts such as struvite–magnesium ammonium phosphate (NH4MgPO4∙6H2O), the phosphorus recovery process recovers at least 15% of the incoming phosphorus load. Only the harvested material, such as struvite, is counted for the calculation of this threshold.

    2. For down-stream recovery after sewage sludge thermal oxidation with chemical phosphorus recovery or after sewage sludge thermal oxidation with thermo chemical phosphorus recovery, the process recovers at least 80% of the incoming phosphorus load from the respective input material, such as sewage sludge ash.

    3. The phosphorus extracted out of the system is used either as a component material in a fertilising product compliant with Regulation (EU) 2019/1009 of the European Parliament and of the Council 39 or national fertiliser legislation where it is more stringent, or in another field of application where the recovered phosphorus fulfils specified functions in accordance with the respective regulations.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    Key performance parameters, including a mass balance for phosphorus pentoxide (P2O5) and key environmental parameters in relation to the identity and quantity of emissions and waste streams generated, are monitored.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.2.Production of alternative water resources for purposes other than human consumption

    Description of the activity

    Construction, extension, operation and renewal of facilities for producing reclaimed water 40 , facilities for harvesting rain and storm water and facilities for collection and treatment of grey water 41 .

    These alternative water resources are used to replace water from abstraction or from the drinking water supply systems and can be used for aquifer recharge, irrigation, industrial reuse, recreation and any other municipal use.

    The economic activity only includes the facilities and processes that make it possible for the water to be reused, such as facilities for recharging aquifers or surface water storages, and does not include the previous steps, such as primary and secondary steps in the waste water treatment plant or the subsequent steps, necessary for the final reuse of these alternative water resources, such as irrigation systems.

    The economic activity does not include desalination (see Section 5.13. of Annex II to Delegated Regulation (EU) 2021/2139).

    This economic activity does not include supply of water for the purpose of human consumption (see Section 2.1. of Annex I).

    The economic activities in this category could be associated with several NACE codes, in particular E37.00 and F42.9 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. For production of reclaimed water, the activity complies with the following criteria:

    (a)the reclaimed water is suitable for reuse. For use in agriculture, the reclaimed water complies with EU requirements, such as those set out in Regulation (EU) 2020/741 of the European Parliament and of the Council 42 and national legislation. For uses other than agricultural irrigation, the final quality of reclaimed water is fit for purpose and compliant with existing national legislation and standards;

    (b)the water reuse project has been authorised by the competent authority, in the framework of integrated water management, having as a priority taken into account viable water demand management and efficiency measures, in consultation with the water management authorities. This may be proven by its inclusion in a water management plan or drought management plan. For reuse in agriculture, the assessments of the environmental risks, including those related to the quantitative status of water bodies, are fully taken into account in the risk management plans, required by Regulation (EU) 2020/741.

    2. For facilities for harvesting rain and storm water, the activity complies with the following criteria:

    (a)the resource (rain or storm water) is segregated at source and does not include waste water;

    (b)the water is suitable for use after proper treatment depending on the level of contamination and subsequent use;

    (c)the facility is included in an instrument of urban planning or permitting, such as Master Plan or municipal planning.

    3. For facilities for collection and treatment of grey waters, the activity complies with the following criteria:

    (a)the resource (grey water) is segregated at source;

    (b)the water is suitable for reuse after proper treatment depending on the level of contamination and subsequent reuse;

    (c)the performance is attested by a building certification or is available in the technical design documents.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    For the production of reclaimed water, an assessment of the direct GHG emissions from the reuse treatment, has been performed 43 . The results are disclosed to investors and clients on demand.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    For the uses prescribed in the EU Regulation (EU) 2020/741, the activity complies with that Regulation or with applicable national legislation where it is stricter. Aquifer recharge and infiltration of surface runoff waters comply with the Directive 2006/118/EC or with applicable national legislation where it is stricter.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.3.Collection and transport of non-hazardous and hazardous waste

    Description of the activity

    Separate collection and transport of non-hazardous and hazardous 44 waste aimed at preparing for re-use 45 or recycling 46 , including the construction, operation and upgrade of facilities involved in the collection and transport of such waste, such as civic amenity centres and waste transfer stations, as a means for material recovery.

    The economic activities in this category could be associated with several NACE codes, in particular E38.11, E38.12 and F42.9 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. All separately collected and transported waste that is segregated at source is intended for preparation for reuse or recycling operations.

    2. Source segregated waste consisting of (i) paper and cardboard, (ii) textiles 47 , (iii) biowaste, (iv) wood, (v) glass, (vi) waste from electrical and electronic equipment (WEEE) or (vii) any type of hazardous waste is collected separately (i.e. in single fractions) and not commingled with other waste streams.

    For source segregated non-hazardous waste other than the fractions mentioned above, collection in co-mingled fractions takes place only where it meets one of the conditions laid down in Article 10, paragraph 3, indents (a), (b) or (c) of Directive 2008/98/EC of the European Parliament and of the Council 48 .

    Different types of hazardous waste may be placed together in a hazardous waste box, cabinet or similar solution under the condition that each waste type is properly packaged to keep the waste separate in the box or cabinet and that hazardous waste is sorted in waste types after collection from households.

    3. For municipal waste streams, the activity complies with one of the following criteria:

    (a)the activity carries out municipal solid waste collection mainly via door-to-door collection schemes or supervised collection points to ensure a high level of separate collection and low rates of contamination;

    (b)the activity carries out separate waste collection within publicly organised waste management systems where waste producers are charged based on a pay-as-you-throw (PAYT) mechanism, at least for the residual waste stream or there are other types of economic instruments in place that incentivize waste segregation at source 49 ;

    (c)the activity carries out separate waste collection outside of publicly organised waste management systems that apply deposit and refund systems or other types of economic instruments that directly incentivize waste segregation at source.

    4. The activity continuously monitors and assesses the quantity and quality of wastes collected based on predefined Key Performance Indicators (KPIs) to comply with all of the following criteria:

    (a)fulfilling reporting obligations vis-a-vis relevant stakeholders, such as public authorities, Extended Producer Responsibility (EPR) schemes;

    (b)periodically communicating relevant information to waste producers and the public in general, in cooperation with relevant stakeholders, such as public authorities, EPR schemes;

    (c)identifying needs for and undertaking corrective action where the KPIs deviate from applicable targets or benchmarks, in cooperation with relevant stakeholders, such as public authorities, EPR schemes, value chain partners.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    1. The activity utilises waste collection vehicles which conform to at least EURO V standards 50 .

    2. Hazardous waste is collected separately from non-hazardous waste to prevent cross-contamination. Appropriate measures are taken to ensure that during separate collection and transport, hazardous waste is not mixed either with other categories of hazardous waste or with other waste, substances or materials. Mixing includes the dilution of hazardous substances.

    3. Proper collection and handling prevent leakage of hazardous waste during collection, transport, storage and delivery to the treatment facility permitted to treat hazardous waste.

    4. Hazardous waste is packaged and labelled in accordance with the international and Union standards in force in the course of collection, transport and temporary storage.

    5. The operator collecting hazardous waste complies with record-keeping obligations,  including as regards quantity, nature, origin,  destination, frequency of collection, mode of transport and treatment method, set out in applicable Union and national legislation

    6. For waste from electrical and electronic equipment (WEEE):

    (a)the main categories of end-of-life Electrical and Electronic Equipment (EEE) set out in Annex III to Directive 2012/19/EU are collected separately;

    (b)collection and transport preserve the integrity of WEEE and prevent the leakage of hazardous substances, such as ozone-depleting substances, fluorinated greenhouse gases or mercury contained in fluorescent lamps.

    7. A management system is set up by the collection and logistics operator to manage environmental, health and safety risks.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A

    2.4.Treatment of hazardous waste

    Description of the activity

    Construction, upgrade, and operation of dedicated facilities for the treatment of hazardous waste as a means for material recovery operations.

    This economic activity covers both in-situ and ex-situ material recovery operations of waste classified as hazardous waste in accordance with the European List of Waste established by Commission Decision 2000/532/EC 51  and in accordance with Annex III to Directive 2008/98/EC. This includes the following streams:

    (a)solvent reclamation or regeneration;

    (b)regeneration of acids and bases;

    (c)recycling or reclamation of inorganic materials other than metals or metal compounds;

    (d)recovery of components used for pollution abatement;

    (e)recovery of components from catalysts;

    (f)re-refining of oil lubricants and other industrial waste oils (excluding for use as fuel or incineration).

    The economic activity does not include the reuse of substances that do not qualify as waste, such as by-products or residues from production activities, in accordance with Article 5 of Directive 2008/98/EC.

    The economic activity does not include recovery of materials from batteries, Waste from Electrical and Electronic Equipment (WEEE), End-of-Life Vehicles (ELV), inorganic materials from incineration processes, such as ashes, slags or dust. The economic activity does not include the treatment and recovery of nuclear waste.

    The economic activities in this category could be associated with several NACE codes, in particular E38.22, E38.32, F42.9 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The activities consist of the material recovery of secondary raw materials (including chemical substances and critical raw materials) from source segregated hazardous waste.

    2. The recovered materials are substituting primary raw materials, including critical raw materials, or chemicals in production processes 52 .

    3. The recovered materials comply with the applicable industry specifications, harmonized standards, or end-of-waste criteria, as well as relevant applicable Union and national legislation.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    The activity, on a life-cycle basis, does not increase GHG emissions as compared to the production based on the equivalent primary raw material(s).

    Life-cycle greenhouse gas emissions are calculated using Commission Recommendation 2013/179/EU 53 or, alternatively, using ISO 14067:2018 54 or ISO 14064-1:2018 55 . Quantified life-cycle GHG emissions are verified by an independent third party.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    Relevant techniques are deployed for the protection of water and marine resources, as set out in the best available techniques (BAT) conclusions for waste treatment 56 .

    (5) Pollution prevention and control

    All substances, and mixtures recovered comply with the applicable relevant legislation, such as Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021, Regulation (EC) No 1272/2008 and Directive 2008/98/EC.

    The activity deploys relevant techniques for pollution prevention and control, as set out in the best available techniques (BAT) conclusions for waste treatment 57 . The activity meets the relevant associated emission limits (BAT-AELs).

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.5.Recovery of bio-waste by anaerobic digestion or composting

    Description of the activity

    Construction and operation of facilities for the treatment of separately collected bio-waste through anaerobic digestion or composting with the resulting production and utilisation of biogas, biomethane, digestate, compost or chemicals.

    The economic activities in this category could be associated with several NACE codes, in particular E38.21 and F42.9 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to circular economy

    1. The bio-waste that is used for anaerobic digestion or composting is source segregated and collected separately. Where bio-waste is collected in biodegradable bags, the bags have the appropriate compostable certification standard EN 13432:2000 58 .

    2. In these anaerobic digestion plants, source segregated bio-waste from separate collection constitutes at least 70% of the input feedstock, measured in weight, as an annual average. Co-digestion may cover up to 30% of the input feedstock of advanced bioenergy feedstock listed in Annex IX to Directive (EU) 2018/2001, which may not include contaminated feedstock coming from biomass fraction of mixed municipal and industrial waste. The input does not include feedstock excluded in Part II of Annex II to Regulation (EU) 2019/1009, for Component Material Category (CMC) 3 (Compost) in accordance with point (c) of that category and for Component Material Category (CMC) 5 (Digestate other than fresh crop digestate) in accordance with point (c) of that category.

    3. The activity produces one of the following:

    (a)compost or digestate complying with Regulation (EU) 2019/1009, in particular with requirements of Annex II on the Component Material Categories (CMC), referring specifically to CMC 3 (Compost) and CMC 5 (Digestate other than fresh crop digestate) or with national rules on fertilisers or soil improvers, with equal or stricter requirements compared to those of Regulation 2019/1009;

    (b)chemicals through the conversion of organic waste to carboxylates, carboxylic acids or polymers by fermentation with mixed cultures.

    4. Quality assurance of the production process is performed using Module D1 set out in Regulation (EU) 2019/1009.

    5. Compost and digestate complying with Regulation (EU) 2019/1009 or equivalent national rules is not landfilled.

    The digestate is preferably composted after anaerobic digestion to maximise benefits to the soil it is applied to afterwards, and minimises some potential agro-environmental issues such as release of ammonia and nitrates.

    6. Where anaerobic digestion is installed, the produced biogas is used directly for the generation of electricity or heat, upgraded to bio-methane for use as a fuel, directly injected in the gas grid and further used for energy purposes by replacing natural gas, used as industry feedstock to produce other chemicals or converted into hydrogen for use as a fuel.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    A monitoring and contingency plan is in place to minimise methane leakage at the facility.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    For anaerobic digestion plants treating over 100 tonnes per day and for composting plants treating over 75 tonnes per day, the activity complies with best available techniques (BAT) conclusions for waste treatment 59  or equal or stricter national regulation, in order to reduce emissions to air and to improve the overall environmental performance as well as to select the waste input and to monitor or control the key waste and process parameters.

    Emissions to air and water are within or lower than the emission levels associated with the best available techniques (BAT-AEL) ranges set for, respectively, anaerobic and aerobic treatment of waste in the latest relevant best available techniques (BAT) conclusions, including the best available techniques (BAT) conclusions for waste treatment 60 .

    For anaerobic digestion, the nitrogen content of the digestate used as fertilisers or soil improver is communicated to the buyer or the entity in charge of taking off the digestate, either in compliance with Regulation (EU) 2019/1009, or with tolerance level ± 25%. .

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.6.Depollution and dismantling of end-of-life products

    Description of the activity

    Construction, operation and upgrade of facilities dismantling and depolluting complex end-of-life products, movable assets and their components for materials recovery or preparation for re-use of components.

    The economic activity includes the dismantling of end-of-life products and movable assets and their components of any type, such as automobiles, ships and electrical and electronic equipment (EEE) for material recovery.

    The economic activity does not include the treatment of batteries stemming from separate collection or removed during dismantling and depollution activities, and the demolition and wrecking of buildings and other structures (see Section 3.3. of this Annex).

    The economic activities in this category could be associated with several NACE codes, in particular E38.31, E38.32 and E42.99 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The economic activity dismantles and depollutes separately collected waste, in state-of-the-art facilities, from complex end-of-life products, such as automobiles, electrical and electronic equipment (EEE) or ships, in order to:

    (a)harvest parts and components that are suited for re-use;

    (b)separate non-hazardous and hazardous waste fractions suited for material recovery including recovery of critical raw materials;

    (c)remove hazardous substances, mixtures and components, so that these are contained in an identifiable 61 stream or that are an identifiable part of a stream within the treatment process, and send them to facilities permitted for proper treatment including disposal of hazardous waste; 

    (d)enclose documentation of the materials that are sent for further treatment or reuse.

    2. The economic activity dismantling and depolluting waste electrical and electronic equipment (WEEE) complies with the requirements set out in Article 8 of Directive 2012/19/EU and in Annexes VII and VIII to that Directive. The economic activity dismantling and depolluting end-of-life vehicles (ELVs) complies with the requirements set out in Article 6 and 7 of Directive 2000/53/EC and in Annex I to that Directive.

    3. For the dismantling and depollution of scrap ships, the facility is included in the European List of ship recycling facilities as laid down in Commission Implementing Decision (EU) 2016/2323 62 . For the construction of a new facility or the upgrade of an existing facility which is not yet included in the European List of ship recycling facilities, the facility fulfils all requirements set out in Article 13 of Regulation (EU) No 1257/2013 of the European Parliament and of the Council 63  and has applied to be included in the European List of ship recycling facilities.

    4. For the dismantling and depollution of Waste from Electrical and Electronic Equipment (WEEE) and End-of-Life vehicles (ELVs), waste originates from collection points meeting the applicable requirements set by Union 64 and national legislation.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    1. The facility is equipped to manage and store safely and in an environmentally sound manner hazardous substances, mixtures and components removed during the depollution operations.

    2. For end-of-life vehicles (ELVs), the facility complies with the requirements for sites for storage and treatment, depollution and treatment operations set in Annex I to Directive 2000/53/EC.

    3. For waste from electrical and electronic equipment (WEEE), the facility complies with the requirements for proper treatment set out in Article 8 of Directive 2012/19/EU, in particular with the requirements for selective treatment for materials and components of WEEE set out in Annex VII to Directive 2012/19/EU and for storage and treatment operations set out in Annex VIII to Directive 2012/19/EU.

    The facility complies with normative requirements relevant to its activities for de-pollution set out in the standards EN 50625-1:2014 65 , EN 50625-2-1:2014 66 , EN 50625-2-2:2015 67 , EN 50625-2-3:2017 68 and EN 50625-2-4:2017 69 .

    Implementation of such measures can also be demonstrated through compliance with regulatory requirements that are equivalent to those set out in the EN standards mentioned above.

    For the treatment of WEEE containing volatile fluorocarbons (VFCs) and volatile hydrocarbons (VHCs) and WEEE containing mercury, emissions are within or lower than the emission levels associated with the best available techniques (BAT-AEL) ranges as set out in the best available techniques (BAT) conclusions for waste treatment 70 .

    4. For ship recycling, the facility complies with the requirements set out in Article 13 of Regulation (EU) No 1257/2013 and is included in the European List of ship recycling facilities established under that Regulation. The facility complies with the requirements set out in Article 7 of that Regulation with regards to the preparation of a ship-specific recycling plan prior to any recycling of a ship.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.7.Sorting and material recovery of non-hazardous waste

    Description of the activity

    Construction, upgrade, and operation of facilities for the sorting or recovery of non-hazardous waste streams into high quality secondary raw materials using a mechanical transformation process.

    The economic activity does not include sorting and recovery of combustible fractions from mixed residual waste for the production of refuse derived fuel, such as in mechanical and biological treatment plants.

    The economic activities in this category could be associated with several NACE codes, in particular E38.32 and F42.9 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. Origin of the feedstock material

    The non-hazardous waste feedstock originates from one or multiple of the following sources:

    (a)separately collected and transported waste, including in commingled fractions 71 ;

    (b)non-hazardous waste fractions originating from dismantling and depollution activities from end-of-life products;

    (c)construction and demolition waste from selective demolition or otherwise segregated at source;

    (d)non-hazardous waste fractions originating from sorting of mixed waste intended for recycling where the facility meets a defined quality criteria of performance and the waste is coming from areas complying with separate collection obligations laid out in Directive 2008/98/EC.

    2. Material recovery

    The activity attains or exceeds existing plant-specific material recovery rates by competent authorities set in applicable waste management plans, permits or contracts or by Extended Producer Responsibility (EPR) schemes. The facility implements internally defined Key Performance Indicators (KPIs) to track performance or attainment of applicable recovery rates.

    For materials for which separate collection is mandatory, the activity converts at least 50 %, in terms of weight, of the processed separately collected non-hazardous waste into secondary raw materials that are suitable for the substitution of primary raw materials in production processes.

    3. Proper management of waste

    The facility recovering non-hazardous waste has implemented Best Available Techniques (BAT) based on BAT 2 on improving overall environmental performance of the plant set out in the best available techniques (BAT) conclusions for waste treatment 72 including:

    (a)a waste characterisation procedure and a strict waste acceptance procedure regarding the quality of incoming waste;

    (b)a tracking system and inventory aiming to track the location and quantity of waste in the plant;

    (c)an output quality management system to ensure that the output of the waste treatment is in line with applicable quality requirements or standards, using for example existing EN or ISO standards;

    (d)the relevant waste segregation measures or procedures to ensure that waste, after separation, is kept separated depending on its properties in order to enable easier and environmentally safer storage and treatment;

    (e)the relevant measures to ensure waste compatibility prior to mixing or blending of waste;

    (f)the facility has installed the sorting and material recovery technology and processes to meet relevant technical specifications, quality standards or end-of-waste criteria. The activity uses state-of-the-art technologies suited to the waste fractions processed including optical separation by near-infrared spectroscopy or X-ray systems, density separation, magnetic separation or size separation.

    4. Quality of secondary raw materials

    The activity converts or allows the conversion of waste into secondary raw materials, including critical raw materials, that are suitable for the substitution of primary raw materials in production processes.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    For activities falling under the scope of the best available techniques (BAT) conclusions for waste treatment 73 , the activity implements the relevant techniques for pollution prevention and control and meets the relevant associated emission limits (BAT-AELs).

    Plastics recycling facilities have filtration installed prior to wash discharge that is capable of removing at least 75% of microplastics >5µm.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    3.Construction and real estate activities 

    3.1.Construction of new buildings

    Description of the activity

    The development of construction projects for residential and non-residential buildings by combining financial, technical, and physical means with a view to sell the building upon delivery or at a later date, as well as the construction of complete residential or non-residential buildings, on own account for sale or on a fee or contract basis.

    The economic activities in this category could be associated with several NACE codes, in particular F41.1, F41.2 and F43, in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. All generated construction and demolition waste is treated in accordance with Union waste legislation and with the full checklist of the EU Construction and Demolition Waste Management Protocol, in particular by setting sorting systems and pre-demolition audits 74 . The preparing for re-use 75 or recycling 76 of the non-hazardous construction and demolition waste generated on the construction site is at least 90% (by mass in kilogrammes), excluding backfilling 77 . This excludes naturally occurring material referred to in category 17 05 04 in the European List of Waste established by Decision 2000/532/EC. The operator of the activity demonstrates compliance with the 90% threshold by reporting on the Level(s) indicator 2.2 78  using the Level 2 reporting format for different waste streams.

    2. The life-cycle Global Warming Potential (GWP) of the building resulting from the construction has been calculated for each stage in the life cycle and is disclosed to investors and clients on demand 79 .

    3. Construction designs and techniques support circularity via the incorporation of concepts for design for adaptability and deconstruction as outlined in Level(s) indicators 2.3 and 2.4 respectively. Compliance with this requirement is demonstrated by reporting on the Level(s) indicators 2.3 80 and 2.4 81 at Level 2.

    4. The use of primary raw material in the construction of the building is minimised through the use of secondary raw materials 82 . The operator of the activity ensures that the three heaviest material categories used to construct the building, measured by mass in kilogrammes, comply with the following maximum total amounts of primary raw material used:

    (a)for the combined total of concrete 83 , natural or agglomerated stone, a maximum of 70% of the material come from primary raw material;

    (b)for the combined total of brick, tile, ceramic, a maximum of 70% of the material come from primary raw material;

    (c)for bio-based materials 84 , a maximum of 80% of the total material come from primary raw material;

    (d)for the combined total of glass, mineral insulation, a maximum of 70% of the total material come from primary raw material;

    (e)for non-biobased plastic, a maximum of 50% of the total material come from primary raw material;

    (f)for metals, a maximum of 30% of the total material come from primary raw material;

    (g)for gypsum, a maximum of 65% of the material come from primary raw material.

    The thresholds are calculated by subtracting the secondary raw material from the total amount of each material category used in the works measured by mass in kilogrammes. Where the information on the recycled content of a construction product is not available, it is to be counted as comprising 100% primary raw material. In order to respect the Waste Hierarchy and thereby favour re-use over recycling, re-used construction products, including those containing non-waste materials reprocessed on site, are to be counted as comprising zero primary raw material. Compliance with this criterion is demonstrated by reporting in accordance with the Level(s) indicator 2.1 85 .

    5. The operator of the activity uses electronic tools to describe the characteristics of the building as built, including the materials and components used, for the purpose of future maintenance, recovery, and reuse, for example using EN ISO 22057:2022 to provide Environmental Product Declarations 86 . The information is stored in a digital format and is made available to investors and clients on demand. In addition, the operator ensures the long-term preservation of this information beyond the useful life of the building by using the information managing systems provided by national tools, such as cadastre or public register.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    The building is not dedicated to extraction, storage, transport or manufacture of fossil fuels.

    The Primary Energy Demand (PED) 87 setting out the energy performance of the building resulting from the construction does not exceed the threshold set for the nearly zero-energy building (NZEB) requirements in national regulation implementing Directive 2010/31/EU of the European Parliament and of the Council 88 . The energy performance is certified using an as built Energy Performance Certificate (EPC).

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    Where installed, except for installations in residential building units, the specified water use for the following water appliances are attested by product datasheets, a building certification or an existing product label in the Union, in accordance with the technical specifications laid down in Appendix E to Annex I to Delegated Regulation (EU) 2021/2139:

    (a)wash hand basin taps and kitchen taps have a maximum water flow of 6 litres/min;

    (b)showers have a maximum water flow of 8 litres/min;

    (c)WCs, including suites, bowls and flushing cisterns, have a full flush volume of a maximum of 6 litres and a maximum average flush volume of 3,5 litres;

    (d)urinals use a maximum of 2 litres/bowl/hour. Flushing urinals have a maximum full flush volume of 1 litre.

    To avoid impact from the construction site, the activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    Building components and materials used in the construction comply with the criteria set out in Appendix C to this Annex.

    Building components and materials used in the construction that may come into contact with occupiers 89 emit less than 0,06 mg of formaldehyde per m³ of test chamber air upon testing in accordance with the conditions specified in Annex XVII to Regulation (EC) No 1907/2006 and less than 0,001 mg of other categories 1A and 1B carcinogenic volatile organic compounds per m³ of test chamber air, upon testing in accordance with CEN/EN 16516 90 or ISO 16000-3:2011 91 or other equivalent standardised test conditions and determination methods. 92  

    Where the new construction is located on a potentially contaminated site (brownfield site), the site has been subject to an investigation for potential contaminants, for example using standard ISO 18400 93

    Measures are taken to reduce noise, dust and pollutant emissions during construction or maintenance works.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    The new construction is not built on one of the following:

    (a)arable land and crop land with a moderate to high level of soil fertility and below ground biodiversity as referred to the EU LUCAS survey 94 ;

    (b)greenfield land of recognised high biodiversity value and land that serves as habitat of endangered species (flora and fauna) listed on the European Red List 95 or the IUCN Red List 96 ;

    (c)land matching the definition of forest as set out in national law used in the national greenhouse gas inventory, or where not available, is in accordance with the FAO definition of forest 97 .

    3.2.Renovation of existing buildings

    Description of the activity

    Construction and civil engineering works or preparation thereof.

    The economic activities in this category could be associated with several NACE codes, in particular F41 and F43 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. All generated construction and demolition waste is treated in accordance with Union waste legislation and the full checklist of the EU Construction and Demolition Waste Management Protocol, in particular by setting sorting systems and pre-demolition audits 98 . The preparing for re-use 99 or recycling 100  of the non-hazardous construction and demolition waste generated on the construction site is at least 70% (by mass in kilogrammes), excluding backfilling 101 . This excludes naturally occurring material referred to in category 17 05 04 in the European List of Waste established by Commission Decision 2000/532/EC. The operator of the activity demonstrates compliance with the 70% threshold by reporting on the Level(s) indicator 2.2 102  using the Level 2 reporting format for different waste streams.

    2. The life cycle Global Warming Potential (GWP) 103 of the building’s renovation works has been calculated for each stage in the life cycle, from the point of renovation, and is disclosed to investors and clients on demand. 

    3. Construction designs and techniques support circularity via the incorporation of concepts for design for adaptability and deconstruction as outlined in Level(s) indicators 2.3 and 2.4 respectively. The operator of the activity demonstrates compliance with this requirement by reporting on the Level(s) indicators 2.3 104 and 2.4 105 at Level 2.

    4. At least 50% of the original building is retained. This is to be calculated based on the gross external floor area retained from the original building using the applicable national or regional measurement methodology, alternatively using the definition of ‘IPMS 1’ contained in the International Property Measurement Standards 106 .

    5. The use of primary raw material in the renovation of the building is minimised through the use of secondary raw materials 107 . The operator of the activity ensures that the three heaviest material categories that have been newly added to the building in the renovation of the building, measured by mass in kilogrammes, comply with the following thresholds regarding the maximum amount of primary raw material used:

    (a)for the combined total of concrete 108 , natural or agglomerated stone, a maximum of 85% of the material come from primary raw material;

    (b)for the combined total of brick, tile, ceramic, a maximum of 85% of the material come from primary raw material;

    (c)for bio-based materials 109 , a maximum of 90% of the material come from primary raw material;

    (d)for the combined total of glass, mineral insulation, a maximum of 85% of the material come from primary raw material;

    (e)for non-biobased plastic, a maximum of 75% of the material come from primary raw material;

    (f)for metals, a maximum of 65% of the material come from primary raw material;

    (g)for gypsum, a maximum of 83% of the material come from primary raw material.

    The thresholds are calculated by subtracting the secondary raw material from the total amount of each material category used in the works measured by mass in kilogrammes. Where the information on the recycled content of the construction product is not available, it is to be counted as comprising 100% primary raw material. In order to respect the Waste Hierarchy and thereby favour re-use over recycling, re-used construction products, including those containing non-waste materials reprocessed on site, are to be counted as comprising zero primary raw material. Compliance with this criterion is demonstrated by reporting in accordance with the Level(s) indicator 2.1 110 .

    6. The operator of the activity uses electronic tools to describe the characteristics of the building as built, including the materials and components used, for the purpose of future maintenance, recovery, and reuse, for example using EN ISO22057:2022 to provide Environmental Product Declarations 111 . The information is stored in a digital format and is made available to investors and clients on demand. In addition, the operator of the activity ensures the long-term preservation of this information beyond the useful life of the building by using the information managing systems provided by national tools, such as cadastre or public register.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    The building is not dedicated to extraction, storage, transport or manufacture of fossil fuels.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    Where installed as part of the renovation works, except for renovation works in residential building units, the specified water use for the following water appliances are attested by product datasheets, a building certification or an existing product label in the Union, in accordance with the technical specifications laid down in Appendix E to Annex I to Delegated Regulation (EU) 2021/2139:

    (a)wash hand basin taps and kitchen taps have a maximum water flow of 6 litres/min;

    (b)showers have a maximum water flow of 8 litres/min;

    (c)WCs, including suites, bowls and flushing cisterns, have a full flush volume of a maximum of 6 litres and a maximum average flush volume of 3,5 litres;

    (d)urinals use a maximum of 2 litres/bowl/hour. Flushing urinals have a maximum full flush volume of 1 litre.

    (5) Pollution prevention and control

    Building components and materials used in the construction comply with the criteria set out in Appendix C to this Annex.

    Building components and materials used in the construction that may come into contact with occupiers 112 emit less than 0,06 mg of formaldehyde per m³ of test chamber air upon testing in accordance with the conditions specified in Annex XVII to Regulation (EC) No 1907/2006 and less than 0,001 mg of other categories 1A and 1B carcinogenic volatile organic compounds per m³ of test chamber air, upon testing in accordance with EN 16516 or ISO 16000-3:2011 113 or other equivalent standardised test conditions and determination methods.

    Measures are taken to reduce noise, dust and pollutant emissions during construction or maintenance works.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A

    3.3.Demolition and wrecking of buildings and other structures

    Description of the activity

    The demolition and wrecking of buildings, roads and runways, railways, bridges, tunnels, waste water treatment works, water treatment works, pipelines, wells and boreholes, power-generating plants, chemical plants, dams and reservoirs, mines and quarries, offshore structures, near shore works, ports, waterway works or land formation and reclamation 114 .

    For projects associated with the activities ‘Construction of New Buildings’ or ‘Renovation of existing buildings’ (see Sections 3.1. and 3.2. of this Annex), where the demolition works and the construction or renovation works are procured under the same contract, the technical screening criteria for the construction or renovation activities apply.

    The economic activity does not include the demolition and wrecking of buildings and other structures carried out as part of the activity ‘Remediation of contaminated sites and areas’ (see Section 2.4. of Annex III).

    The economic activities in this category could be associated with NACE code F43.1 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. Prior to the start of the demolition or wrecking activity, at least the following aspects from the Level 1 design concept checklist of the Level(s) indicator 2.2 115 checklist are discussed and agreed upon with the client:

    (a)definition of key performance indicators and target ambition level;

    (b)identification of project-specific constraints that may compromise the target ambition level (such as time, labour and space) and how to minimise these constraints;

    (c)details of the pre-demolition auditing procedure;

    (d)an outline waste management plan that prioritises selective deconstruction, decontamination and source separation of waste streams. Where these actions are not prioritised, an explanation is provided to justify why selective deconstruction, decontamination or source separation of waste streams are not technologically feasible in the project. Cost or financial considerations are not an acceptable reason to avoid complying with this requirement.

    2. The operator of the activity conducts a pre-demolition audit in line with the EU Construction and Demolition Waste Management Protocol 116

    3. All demolition waste generated during the demolition or wrecking activity is treated in accordance with Union waste legislation and the full checklist of the EU Construction and Demolition Waste Management Protocol 117 .

    4. The preparing for re-use 118 or recycling 119  of the non-hazardous construction and demolition waste generated on the construction site is at least 90% (by mass in kilogrammes), excluding backfilling 120 . This excludes naturally occurring material referred to in category 17 05 04 in the European List of Waste established by Commission Decision 2000/532/EC. The operator of the activity demonstrates compliance with the 90% threshold by reporting on the Level(s) indicator 2.2 121 using the Level 3 reporting format for different waste streams. Alternatively, at least 95% of the mineral 122 fraction and 70% of the non-mineral fraction of the non-hazardous demolition waste is separately collected and prepared for reuse or recycled.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    The building owner or contractor ensures that during renovation, refurbishing or demolition activities implying the removal of foam panels, or laminated boards installed in cavities or built up structures, that contain foams with Fluorinated greenhouse gases, saturated and unsaturated Hydrofluorocarbons, and Ozone Depleting Substances, as defined in Regulation (EU) No 517/2014 and in Regulation (EU) No 1005/2009, the emissions are avoided to the extent possible by handling the foams or the gases contained therein in a way that ensures the reuse or destruction of the foam panels or the gases contained in the foams. The recovery of the gases contained in the foams is carried out by appropriately trained personnel.

    Where recovery of these foams is not technically feasible, the operator draws up documentation providing evidence for the infeasibility of the recovery in the specific case. Such documentation is retained for five years and is made available, on demand.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    Measures are taken to reduce noise, dust and pollutant emissions during demolition and wrecking works.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    3.4.Maintenance of roads and motorways

    Description of the activity

    Maintenance of streets, roads and motorways, other vehicular and pedestrian ways, surface work on streets, roads, highways, bridges, tunnels, aerodrome runways, taxiways and aprons, defined as all actions undertaken to maintain and restore the serviceability 123 and level of service of roads 124 . For bridges and tunnels, the economic activity only includes the maintenance of the road that runs on the bridge or through the tunnel. It does not include the maintenance of the bridge or tunnel itself.

    The economic activity includes routine maintenance, which can be scheduled on a periodical basis. The economic activity also includes preventive maintenance and rehabilitation which are defined as works undertaken to preserve or restore serviceability and to extend the service life 125 of an existing road. The maintenance operation is mainly dedicated to pavement management and concerns only the following main elements of the road: binder course, surface course and concrete slabs. The roads in the scope of this economic activity are made of asphalt, concrete or a combination of the two.

    The economic activities in this category could be associated with NACE code F42.11 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. Where main road elements (binder course, surface course or concrete slabs) are demolished or removed, the preparing for re-use 126 or recycling 127  of the non-hazardous waste generated onsite is 100% (by mass in kilogrammes), excluding backfilling 128 . This excludes naturally occurring material referred to in category 17 05 04 in the European List of Waste established by Commission Decision 2000/532/EC.

    2. Where the road elements (binder course, surface course and concrete slabs) are newly installed after demolition or removal, including any roads which are built on a temporary basis for the purpose of carrying out the maintenance works, at least 50% (by mass in kilogrammes) of the structural road elements used are re-used or recycled materials or non-hazardous industrial by-products.

    3. The re-used or recycled materials are not moved over distances greater than 2.5 times the distance between the construction site and the nearest production facility for equivalent primary raw materials, to avoid that the use of re-used or recycled materials leads to higher CO2 emissions than the use of primary raw materials.

    4. Where newly installed, the binder course has a service lifetime no shorter than 20 years 129 .

    5. The use of primary raw material for road furniture is minimised through the use of secondary raw materials 130 . The operator of the activity ensures that for metals, such as steel restraint systems, a maximum of 30% of the material come from primary raw material. The threshold is calculated by subtracting the secondary raw material from the total amount of each material category used in the works measured by mass in kilogrammes. Where the information on the recycled content of the construction product is not available, it is to be counted as comprising 100% primary raw material. In order to respect the Waste Hierarchy and thereby favour re-use over recycling, re-used construction products, including those containing non-waste materials reprocessed on site, are to be counted as comprising zero primary raw material.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    A traffic congestion mitigation plan to be implemented during the maintenance works is presented.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    Measures are taken to reduce noise, vibrations, dust and pollutant emissions during construction or maintenance works. When choosing road surface types, low noise road surfaces are preferred, in accordance with the comprehensive criterion B7 ‘minimum requirements for low-noise pavement design’ of the EU Green Public Procurement Criteria for Road Design, Construction and Maintenance 131 , and considering low-noise road surfaces a priority for all roads under the scope of Directive 2002/49/EC.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    3.5.Use of concrete in civil engineering

    Description of the activity

    Use of concrete for new construction, reconstruction, or maintenance 132 of civil engineering objects, except concrete road surfaces on the following elements: streets, motorways, highways, other vehicular and pedestrian ways, bridges, tunnels and aerodrome runways, taxiways and aprons that are covered under the economic activity ‘Maintenance of roads and motorways’ (See Section 3.4. of this Annex).

    An economic activity in this category could be associated with several NACE codes, in particular F42.12, F42.13, F42.2, F42.9, in accordance with the statistical classification for economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. All generated construction and demolition waste is treated in accordance with Union waste legislation and the full checklist of the EU Construction and Demolition Waste Management Protocol, in particular by setting sorting systems 133 . The preparing for re-use 134 or recycling 135  of the non-hazardous construction and demolition waste generated on the construction site is at least 90% (by mass in kilogrammes), excluding backfilling 136 . This excludes naturally occurring material referred to in category 17 05 04 in the European List of Waste established by Commission Decision 2000/532/EC. The operator of the activity demonstrates compliance with the 90% threshold by reporting on the Level(s) indicator 2.2 using the Level 2 reporting format for different waste streams.  

    2. Construction designs and techniques support circularity via the incorporation of concepts for design for adaptability and deconstruction as outlined in Level(s) indicators 2.3 and 2.4 respectively. Compliance with this requirement is demonstrated by reporting on the Level(s) indicators 2.3 137 and 2.4 138 at Level 2.

    3. The use of primary raw material is minimised through the use of secondary raw materials 139 . For concrete, a maximum of 70% of the material comes from primary raw material. This criterion applies to in-situ poured concrete, pre-cast products, and all constituent materials, including any reinforcement. The threshold is calculated by subtracting the secondary raw material from the total amount of material used measured by mass in kilogrammes. Where the information on the recycled content of the construction product is not available, it is to be counted as comprising 100% primary raw material. In order to respect the Waste Hierarchy and thereby favour re-use over recycling, re-used construction products, including those containing non-waste materials reprocessed on site, are to be counted as comprising zero primary raw material.  

    4. The secondary raw materials are not moved over distances greater than 2.5 times the distance between the construction site and the nearest production facility for equivalent primary raw materials, to avoid that the use of re-used or recycled materials leads to higher CO2 emissions than the use of primary raw materials.

    5. The operator of the activity uses electronic tools to describe the characteristics of the building as built, including the materials and components used, for the purpose of future maintenance, recovery, and reuse, for example using EN ISO 22057:2022 to provide Environmental Product Declarations 140 . The information is stored in a digital format and is made available to investors and clients on demand. In addition, the operator ensures the long-term preservation of this information beyond the useful life of the building by using the information managing systems provided by national tools, such as cadastre or public register.

    6. Bridges, tunnels, dikes and sluices are inspected regularly by a nationally approved inspector and the data is used to predict maintenance needs.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    The built asset is not dedicated to the extraction, storage, transport or manufacture of fossil fuels.

    For the cement used in this activity, the greenhouse gas emissions 141 from the production processes are:

    (a)for grey cement clinker, lower than 0,816 142 tCO2e per tonne of grey cement clinker;

    (b)for cement from grey clinker or alternative hydraulic binder, lower than 0,530 143 tCO2e per tonne of cement or alternative binder manufactured.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    Components and materials used in the construction comply with the criteria set out in Appendix C to this Annex.

    Components and materials used in the construction that may come into contact with occupiers 144 emit less than 0,06 mg of formaldehyde per m³ of test chamber air upon testing in accordance with the conditions specified in Annex XVII to Regulation (EC) No 1907/2006 and less than 0,001 mg of other categories 1A and 1B carcinogenic volatile organic compounds per m³ of test chamber air, upon testing in accordance with CEN/EN 16516 145 or ISO 16000-3:2011 146 or other equivalent standardised test conditions and determination methods. 147  

    Where the new construction is located on a potentially contaminated site (brownfield site), the site has been subject to an investigation for potential contaminants, for example by using standard ISO 18400.

    Measures are taken to reduce noise, vibrations, dust and pollutant emissions during construction or maintenance works.

    Where appropriate, given the sensitivity of the area affected, in particular in terms of the size of population and fauna affected, noise and vibrations from construction, use and maintenance of infrastructure are mitigated by acoustical planning introducing open trenches, wall barriers or other appropriate measures in compliance with Directive 2002/49/EC of the European Parliament and of the Council 148 .

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    In addition, the following is to be ensured:

    (a)in the EU, in relation with Natura 2000 sites: the activity does not have significant effects on Natura 2000 sites in view of their conservation objectives on the basis of an appropriate assessment carried out in accordance with Article 6(3) of Council Directive 92/43/EEC;

    (b)in the EU, in any area: the activity is not detrimental to the recovery or maintenance of the populations of species protected under Directive 92/43/EEC and Directive 2009/147/EC at a favourable conservation status. The activity is also not detrimental to the recovery or maintenance of the habitat types concerned and protected under Directive 92/43/EEC at a favourable conservation status;

    (c)outside of the EU, activities are conducted in accordance with applicable law related to the conservation of habitats and species.

    4.Information and communication

    4.1.Provision of IT/OT data-driven solutions

    Description of the activity

    The activity manufactures, develops, installs, deploys, maintains, repairs or provides professional services, including technical consulting for design or monitoring of:

    (a)software 149 and information technology (IT) or operational technology (OT) systems 150 , including artificial intelligence (AI) based solutions, such as for automated machine learning, built for the purpose of remote monitoring and predictive maintenance, including systems for:

    (i)remotely collecting, processing, transferring, and storing data from equipment, products or infrastructure during their use or operation;

    (ii)analysing the data and generating insights about the operational performance and condition of the equipment, product or infrastructure;

    (iii)providing remote maintenance and recommendations about measures required to avoid operational failure and maintain the equipment, product or infrastructure in an optimal operating condition and prolong their useful life and reduce resource use and waste;

    (b)tracking and tracing software and IT or OT systems built for the purpose of providing identification, tracking and tracing of materials, products and assets through their respective value chains (including digital material and product passports) with the predominant objective to support the circularity of material flows and products or other objectives set out in Regulation (EU) 2020/852;

    (c)lifecycle assessment software supporting the lifecycle assessment and related reporting for products, equipment or infrastructures;

    (d)design and engineering software supporting the eco-design of products, equipment, and infrastructure, including waste management and resource efficiency;

    (e)supplier management software supporting green procurement of materials, products and services with low environmental impact, but excluding the operation of market places supporting the trading of such goods;

    (f)lifecycle performance management software supporting the monitoring and assessment of the circularity performance of products, equipment, or infrastructures during their lifecycle.

    The economic activities in this category could be associated with several NACE codes, in particular C26, C27, J58.29, J61, J62 and J63.1 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    An economic activity in this category is an enabling activity in accordance with Article 13(1), point (l), of Regulation (EU) 2020/852 where it complies with the technical screening criteria set out in this Section.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The economic activity manufactures, develops, installs, deploys, maintains, repairs or provides professional services, including technical consulting for design or monitoring, to one or more of the following IT/OT data-driven solutions that provide the capabilities listed below. Such IT/OT data-driven solutions include sensors (such as power, temperature, vibration, video, sound, viscosity), data collection and communication equipment, data repository (edge or cloud), and software. Where these capabilities are part of a broader software or IT/OT offering, only specific software add-ons implementing these capabilities qualify.

    2. For remote monitoring and predictive maintenance systems, at least two of the following capabilities specified in points (a) to (d) are met in their full scope:

    (a)alerting the user to abnormal sensor values, and assessing the status of the product, equipment, or infrastructure, detecting wear and tear or electrical issues, and drawing conclusions about the exact nature of abnormal operating conditions by means of advanced analytical methods;

    (b)predicting the expected remaining lifetime of a product, equipment, or infrastructure, and recommending measures to extend the remaining lifetime;

    (c)predicting an upcoming product, equipment or infrastructure failure and recommending measures to prevent such failure;

    (d)providing recommendations about the highest value next use cycle, such as reuse, recovering components through parts harvesting for remanufacture, or recycling, taking into consideration a combination of factors regarding the product’s condition.

    IT/OT systems aimed at (i) monitoring for the replacement of consumables 151 , such as printer ink, (ii) remote monitoring and remote maintenance of power generation plants that are more greenhouse gas intensive than 100 gCO2e/kWh, or (iii) monitoring and remote management of any type of fossil fuel engine do not qualify.

    3. For tracking and tracing software and IT/OT systems, at least one of the following capabilities specified in points (a) to (d) is met in its full scope:

    (a)providing identification, tracking and tracing of materials, products and assets through value chains in order to make accessible structured data (such as material content, substances, environmental information) required for lifecycle assessments or material declarations according to relevant standards, such as Commission Recommendation 2021/2279, ISO 14067:2018 152 or ISO 14040:2006 153 , and sharing of such data with value chain partners, consumers, and other economic actors in compliance with relevant standards regarding data modelling, interoperability, data privacy and data security;

    (b)provisioning and sharing of documents and data directly supporting the repair and maintenance of products and equipment, such as repair instruction, test equipment, wiring and connection diagrams, diagnostic fault and error codes, disassembly instructions;

    (c)supporting reverse logistics, including the take-back of products for remanufacturing, refurbishment or recycling, by managing steps and transactions in the take-back process, such as pick-up order placement, tracking of sales transaction data, decomposition of product into materials to be re-injected into circular material flows, and by optimising decisions to prevent downcycling and maximise resource recovery. Digital product passports meeting the minimum requirements in Union law are not considered as taxonomy aligned;

    (d)supporting optimisation and intensification of the use of products, through circular business models such as providing products as a service or peer-to-peer sharing.

    4. For lifecycle assessment software, at least one of the following capabilities specified in points (a) to (c) is met in its full scope:

    (a)supporting the life cycle assessment of products, equipment or infrastructure with software-implemented methods and algorithms according to relevant standards such as Commission Recommendation (EU) 2021/2279, ISO 14067:2018 154 or ISO 14040:2006 155 ;

    (b)providing data required for lifecycle analysis, such as standard carbon emission values and other environmental impacts for frequently used products and materials or production steps;

    (c)providing recommendations for improving the design of a product, equipment, or infrastructure so as to minimize their material and carbon footprint.

    5. For design and engineering software, at least one of the following capabilities specified in points (a) to (e) is met in its full scope:

    (a)supporting users to formulate, document and manage product-specific circularity and other environmental design goals and requirements, such as design-for-remanufacturability, design-for-serviceability, minimal environmental impact from using or operating the product, minimal waste during production or construction and tailored production to eliminate over-specification and reduce material inputs;

    (b)supporting users to explore product designs for the purpose of assessing and optimising product designs against specified circular or other environmental objectives, or finding the best trade-off between conflicting design goals, such as robustness vs. material use, greener material vs. costing or installing schedule or cost of downstream reuse and recycling systems;

    (c)validating a design through analysis and simulation against specified circularity and other environmental design goals and requirements;

    (d)supporting the computer-aided product design process – including mechanical, electrical, electronic or recipe design – with data and information about the impact of design and construction decisions on circularity and environmental performance;

    (e)supporting the selection of materials and components with a low environmental impact through the provision of data about market-available materials and components and their cost.

    6. For supplier management software, at least one of the following capabilities specified in points (a) to (e) is met in its full scope:

    (a)providing the user with information about suppliers and supplies of circular products, immediate products, components and materials that are designed for closed loop systems, reuse, remanufacturing or repurposing. The information provided exceeds the minimum information requirements in existing Union law 156 ;

    (b)supporting the management and tracking suppliers’ compliance with standards and certifications related to the provision of such materials, products, and components;

    (c)supporting the exchange with suppliers of data required to verify the environmental performance of supplied materials, products, and components;

    (d)supporting the trading and matchmaking between suppliers and purchasers of circular, eco-designed or otherwise eco-friendly products, materials, and components;

    (e)supporting reverse logistics.

    7. For lifecycle performance management software, at least one of the following capabilities specified in points (a) to (e) is met in its full scope:

    (a)supporting the monitoring and assessment of the circularity performance 157 of a product, equipment or infrastructure during its lifecycle over time;

    (b)comparing circularity performance against original circularity design goals, analysing deviations and their root causes;

    (c)supporting the planning and documentation of measures required to prolong the useful life of the product, equipment or infrastructure, such as maintenance, retrofit, or other services;

    (d)supporting the impact assessment of such measures on circularity performance;

    (e)providing the user with data required to take decisions on the future use of the product, equipment, or infrastructure, such as retrofit, change of use, decommissioning and recycling.

    8. All IT/OT data-driven solutions should meet the following criteria:

    (a)techniques are adopted that support the reuse and use of secondary raw materials and reused components, and the solutions are designed for high durability, recyclability, easy disassembly, adaptability and upgradability;

    (b)measures are in place to manage and recycle waste at the end-of life, including through decommissioning contractual agreements with recycling service providers, reflection in financial projections or official project documentation. These measures ensure that components and materials are segregated and treated to maximise recycling and reuse in accordance with the waste hierarchy, EU waste regulation principles and applicable regulations, in particular through the reuse and recycling of batteries and electronics and the critical raw materials therein. These measures also include the control and management of hazardous materials;

    (c)preparation for re-use, recovery or recycling operations, or proper treatment, including the removal of all fluids and a selective treatment are performed in accordance with Annex VII to Directive 2012/19/EU.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The equipment used to operate the software meets the requirements laid down in Directive 2009/125/EC for servers and data storage products.

    The equipment used does not contain the restricted substances listed in Annex II to Directive 2011/65/EU, except where the concentration values by weight in homogeneous materials do not exceed the maximum values listed in that Annex.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A

    5.Services 

    5.1.Repair, refurbishment and remanufacturing

    Description of the activity

    Repair 158 , refurbishment 159 and remanufacturing 160 of goods that have been used for their intended purpose before by a customer (physical person or legal person).

    The economic activity does not include replacement of consumables 161 , such as printer ink, toner cartridges, lubricants for moving parts or batteries.

    The economic activity relates to products that are manufactured by economic activities classified under the NACE codes C13 Manufacture of textiles, C14 Manufacture of wearing apparel, C15 Manufacture of leather and related products, C16 Manufacture of wood and of products of wood and cork, except furniture; manufacture of articles of straw and plaiting materials, C22 Manufacture of rubber and plastic products, C23.3 Manufacture of clay building materials, C23.4 Manufacture of other porcelain and ceramic products, C25.1 Manufacture of structural metal products, C25.2 Manufacture of tanks, reservoirs and containers of metal, C25.7 Manufacture of cutlery, tools and general hardware, C25.9 Manufacture of other fabricated metal products, C26 Manufacture of computer, electronic and optical products, C27 Manufacture of electrical equipment, C28.22 Manufacture of lifting and handling equipment, C28.23 Manufacture of office machinery and equipment (except computers and peripheral equipment), C28.24 Manufacture of power-driven hand tools, C28.25 Manufacture of non-domestic cooling and ventilation equipment, C28.93 Manufacture of machinery for food, beverage and tobacco processing, excluding machinery for tobacco processing, C28.94 Manufacture of machinery for textile, apparel and leather production, C28.95 Manufacture of machinery for paper and paperboard production, C28.96 Manufacture of plastic and rubber machinery, C31 Manufacture of furniture and C32 Other manufacturing.

    The economic activities in this category have no dedicated NACE codes as referred to in the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The economic activity consists of extending the lifetime of products by repairing, refurbishing or remanufacturing products that have already been used for their intended purpose by a customer (physical person or legal person).

    2. The economic activity complies with the following criteria:

    (a)the replaced parts, the refurbished products or the remanufactured products are covered by a sales contract where relevant and in accordance with provisions as regards conformity of the product, liability of the seller 162 (including the option of a shorter liability or limitation period for second hand products), burden of proof, remedies for lack of conformity, the modalities for the exercise of those remedies, repair or replacement of the goods, and commercial guarantees;

    (b)the economic activity implements a waste management plan that ensures that the product’s materials, particularly critical raw materials, and components that have not been reused in the same product are reused elsewhere, or, where reuse is not possible (due to damage, degradation or hazardous substances), are recycled, or, only where reuse and recycling is not viable, are disposed of in accordance with applicable Union and national legislation. For remanufacturing, the waste management plan is accessible to the public.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the activity involves on-site generation of heat/cool or co-generation including power, the direct GHG emissions of the activity are lower than 270 gCO2e/kWh.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The activity complies with the criteria set out in Appendix C to this Annex.

    Spare parts installed through repair, refurbishment or remanufacturing comply with all relevant Union rules on the restriction of the use of hazardous substances, of generic nature or with specific relevance to that product category, such as Regulation (EC) No 1907/2006, Directive 2011/65/EU, and Directive (EU) 2017/2102 of the European Parliament and of the Council 163 .

    For repair or refurbishment activities, those requirements do not apply to the original components that have been retained in the product.

    For installations falling within the scope of Directive 2010/75/EU, emissions are within or lower than the emission levels associated with the best available techniques (BAT-AEL) ranges set out in the latest relevant best available techniques (BAT) conclusions and ensures at the same time that no significant cross-media effects occur.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A

    5.2.Sale of spare parts

    Description of the activity

    Sale of spare parts 164 .

    The economic activity does not include replacement of consumables, such as printer ink, toner cartridges, lubricants for moving parts or batteries and maintenance.

    The economic activity relates to spare parts that are used in products manufactured by economic activities classified under the NACE codes C26 Manufacture of computer, electronic and optical products, C27 Manufacture of electrical equipment, C28.22 Manufacture of lifting and handling equipment, C28.23 Manufacture of office machinery and equipment (except computers and peripheral equipment), C28.24 Manufacture of power-driven hand tools and C31 Manufacture of furniture.

    The economic activities in this category could be associated with several NACE codes, in particular G46 and G47 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The economic activity consists of the sale of spare parts beyond legal obligations.

    2. The economic activity complies with the following criteria:

    (a)each sold spare part is covered by a sales contract where relevant and in accordance with provisions as regards conformity of the product, liability of the seller 165 (including the option of a shorter liability or limitation period for second hand products), burden of proof, remedies for lack of conformity, the modalities for the exercise of those remedies, repair or replacement of the goods, and commercial guarantees;

    (b)each sold spare part for a product replaces, or intends to replace in the future, an existing part in order to restore or upgrade the product’s functionality, in particular in case where the existing part is broken.

    3. Where the economic activity involves delivery of packaged products to customers (physical person or legal person) including when the activity is operated as an e-commerce 166 , the primary and secondary packaging of the product complies with one of the following criteria:

    (a)the packaging is made of at least 65% recycled material. Where the packaging is made from paper or cardboard, the remaining primary raw material are certified by the Forest Stewardship Council (FSC), the Programme for the Endorsement of Forest Certification Schemes (PEFC International), or equivalent recognised schemes. Coatings with plastics or metals are not used. For plastic packaging only mono-materials without coatings are used, halogen-containing polymers are not used. A declaration of compliance is provided specifying the material composition of the packaging and the shares of recycled and primary raw material;

    (b)the packaging has been designed to be reusable within a reuse system 167 . The system for reuse is established in a way that ensures the possibility of reuse in a closed-loop or open-loop system.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the activity involves on-site generation of heat/cool or co-generation including power, the direct GHG emissions of the activity are lower than 270 gCO2e/kWh.

    The activity develops a strategy to account for and reduce the GHG emissions arising from transport along the value chain, including shipping and returns, to the extent these are traceable.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The activity complies with the criteria set out in Appendix C to this Annex.

    Sold spare parts comply with all relevant EU rules on the restriction of the use of hazardous substances, of generic nature or with specific relevance to that product category, such as Regulation (EC) No 1907/2006, Directive 2011/65/EU, and Directive (EU) 2017/2102.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A

    5.3.Preparation for re-use of end-of-life products and product components

    Description of the activity

    Preparation for re-use of products and components at the end of life 168 .

    The economic activity does not include repair activities, which are performed during the product’s use stage.

    The economic activity relates to products and their components manufactured by economic activities classified under the NACE codes C13 Manufacture of textiles, C14 Manufacture of wearing apparel, C15 Manufacture of leather and related products, C16 Manufacture of wood and of products of wood and cork, except furniture; manufacture of articles of straw and plaiting materials, C18 Printing and reproduction of recorded media, C22 Manufacture of rubber and plastic products, C23.3 Manufacture of clay building materials, C23.4 Manufacture of other porcelain and ceramic products, C25.1 Manufacture of structural metal products, C25.2 Manufacture of tanks, reservoirs and containers of metal, C25.7 Manufacture of cutlery, tools and general hardware, C25.9 Manufacture of other fabricated metal products, C26 Manufacture of computer, electronic and optical products, C27 Manufacture of electrical equipment, C28.22 Manufacture of lifting and handling equipment, C28.23 Manufacture of office machinery and equipment (except computers and peripheral equipment), C28.24 Manufacture of power-driven hand tools, C28.25 Manufacture of non-domestic cooling and ventilation equipment, C28.93 Manufacture of machinery for food, beverage and tobacco processing, excluding machinery for tobacco processing, C28.94 Manufacture of machinery for textile, apparel and leather production , C28.95 Manufacture of machinery for paper and paperboard production, C28.96 Manufacture of plastic and rubber machinery, C29 Manufacture of motor vehicles, trailers and semi-trailers, C30.1 Building of ships and boats, C30.2 Manufacture of railway locomotives and rolling stock, C30.3 Manufacture of air and spacecraft and related machinery, C30.9 Manufacture of transport equipment n.e.c., C31 Manufacture of furniture and C32 Other manufacturing.

    The economic activities in this category have no dedicated NACE code as referred to in the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The activity prepares for re-use products or components of products that have become waste so that they can be re-used without any other pre-processing.

    2. The activity’s waste feedstock originates from separately collected and transported waste in source segregated or comingled fractions 169 .

    3. The activity has implemented acceptance, safety and inspection procedures that comply with the following criteria:

    (a)a procedure is in place to check the suitability for preparing for re-use or recycling, and that the activity implements a publicly available waste management plan, which ensures that discarded end-of-life products not suitable for preparing for re-use (due to damage, degradation or hazardous substances) are sent for recycling or, only where reuse and recycling is not viable, disposed of;

    (b)the procedure which can be based on visual or manual external inspection against pre-determined criteria is suited to the category of discarded end-of-life products, which are prepared for re-use;

    (c)proper training is provided and ensures that the re-use operators are qualified for the preparing for re-use activities of the discarded end-of-life products at stake.

    4. The activity uses the tools and equipment suited for the preparation for re-use of discarded end-of-life products.

    5. The activity has a system to report recovery rate and, where applicable, targets for preparing for re-use or recycling set out by Union or national legislation.

    6. The activity complies with the following criteria:

    (a)the output of the activity are products or components of products which are suitable for re-use without any other processing;

    (b)sold goods are covered by a sales contract where relevant and in accordance with provisions as regards conformity of the product, liability of the seller 170 (including the option of a shorter liability or limitation period for second hand products), burden of proof, remedies for lack of conformity, the modalities for the exercise of those remedies, repair or replacement of the goods, and commercial guarantees.

    7. For the preparation for re-use of Waste from Electrical and Electronic Equipment (WEEE), the economic activity is permitted to treat waste and implements an environmental management system using ISO 14001:2015 171 , the EU Eco-Management and Audit Scheme (EMAS) in accordance with Regulation (EC) 1221/2009 of the European Parliament and of the Council 172 or equivalent and a Quality management system using ISO 9001:2015 173 .

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the activity involves on-site generation of heat/cool or co-generation including power, the direct GHG emissions of the activity are lower than 270 gCO2e/kWh.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The activity complies with the criteria set out in Appendix C to this Annex.

    The activity implements safety procedures required to protect the health and safety of workers carrying out preparing for re-use operations.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A

    5.4.Sale of second-hand goods

    Description of the activity

    Sale of second-hand goods that have been used for their intended purpose before by a customer (physical person or legal person), possibly after repair, refurbishment or remanufacturing.

    The economic activity relates to products manufactured by economic activities classified under the NACE codes C13 Manufacture of textiles, C14 Manufacture of wearing apparel, C15 Manufacture of leather and related products, C16 Manufacture of wood and of products of wood and cork, except furniture; manufacture of articles of straw and plaiting materials, C18 Printing and reproduction of recorded media, C22 Manufacture of rubber and plastic products, C23.3 Manufacture of clay building materials, C23.4 Manufacture of other porcelain and ceramic products, C25.1 Manufacture of structural metal products, C25.2 Manufacture of tanks, reservoirs and containers of metal, C25.7 Manufacture of cutlery, tools and general hardware, C25.9 Manufacture of other fabricated metal products, C26 Manufacture of computer, electronic and optical products, C27 Manufacture of electrical equipment, C28.22 Manufacture of lifting and handling equipment, C28.23 Manufacture of office machinery and equipment (except computers and peripheral equipment), C28.24 Manufacture of power-driven hand tools, C28.25 Manufacture of non-domestic cooling and ventilation equipment, C28.93 Manufacture of machinery for food, beverage and tobacco processing, excluding machinery for tobacco processing, C28.94 Manufacture of machinery for textile, apparel and leather production, C28.95 Manufacture of machinery for paper and paperboard production, C28.96 Manufacture of plastic and rubber machinery, C29 Manufacture of motor vehicles, trailers and semi-trailers, C31 Manufacture of furniture, C32 Other manufacturing.

    The economic activities in this category could be associated with several NACE codes, in particular G46 and G47 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The economic activity consists of selling a second-hand product that had been used for its intended purpose by a customer (physical person or legal person), potentially after its prior cleaning, repair, refurbishment or remanufacturing.

    2. The sold product is covered by a sales contract where relevant and in accordance with provisions as regards conformity of the product, liability of the seller 174 (including the option of a shorter liability or limitation period for second hand products), burden of proof, remedies for lack of conformity, the modalities for the exercise of those remedies, repair or replacement of the goods, and commercial guarantees.

    3. Where the product has been repaired, refurbished or remanufactured before reselling, the activity implements a waste management plan that ensures that the product’s materials and components that have not been reused in the same product, are reused elsewhere, or where reuse is not possible (for example due to damage, degradation or hazardous substances), are recycled, or, only where reuse and recycling are not viable, are disposed of. For remanufacturing, the waste management plan is accessible to the public.

    4. Where the economic activity involves delivery of packaged products to customers (physical person or legal person) including when the activity is operated as an e-commerce 175 , the primary and secondary packaging of the product complies with one of the following criteria:

    (a)the packaging is made of at least 65% recycled material. Where the packaging is made from paper or cardboard, the remaining primary raw material are certified by the Forest Stewardship Council (FSC), the Programme for the Endorsement of Forest Certification Schemes (PEFC International), or equivalent recognised schemes. Coatings with plastics or metals are not used. For plastic packaging only mono-materials without coatings are used, halogen-containing polymers are not used. A declaration of compliance is provided specifying the material composition of the packaging and the shares of recycled and primary raw material;

    (b)the packaging has been designed to be reusable within a reuse system 176 . The system for reuse is established in a way that ensures the possibility of reuse in a closed-loop or open-loop system.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the activity involves on-site generation of heat/cool or co-generation including power, the direct GHG emissions of the activity are lower than 270 gCO2e/kWh.

    The activity develops a strategy to account for and reduce the GHG emissions arising from transport along the value chain, including shipping and returns, to the extent these are traceable.

    Where the sold product is initially produced by the activities classified under NACE codes C29, and is a vehicle, mobility component, system, separate technical unit, part or a spare part as defined in Regulation (EU) 2018/858, when sold in the secondary market after 2025 and before 2030 the following criteria apply:

    (a)vehicles of category M1 and N1 classified as light-duty vehicles comply with specific emissions limits of CO2, as defined in Article 3(1), point (h), of Regulation (EU) 2019/631 of the European Parliament and of the Council 177 , lower than 50gCO2/km (low- and zero-emission light-duty vehicles);

    (b)vehicles of category L 178 with tailpipe CO2 emissions equal to 0g CO2e/km calculated in accordance with the emission test laid down in Regulation (EU) 168/2013 of the European Parliament and of the Council 179 ;

    (c)vehicles of categories N2 and N3, and N1 classified as heavy-duty vehicles, not dedicated to transporting fossil fuels with a technically permissible maximum laden mass not exceeding 7,5 tonnes that are ‘zero-emission heavy-duty vehicles’ as defined in Article 3, point (11), of Regulation (EU) 2019/1242;

    (d)vehicles of categories N2 and N3 not dedicated to transporting fossil fuels with a technically permissible maximum laden mass exceeding 7,5 tonnes that are zero-emission heavy-duty vehicles’, as defined in Article 3, point (11), of Regulation (EU) 2019/1242 or ‘low-emission heavy-duty vehicles’ as defined in Article 3, point (12) of that Regulation.

    Where the product, initially produced by the activities classified under NACE codes C29, and being a vehicle, mobility component, system, separate technical unit, part or a spare part as defined in Regulation (EU) 2018/858, is sold in the secondary market after 2030 specific emissions of CO2, as defined in Article 3(1), point (h), of Regulation (EU) 2019/631 are zero.

    Where product sold is initially produced by the activities classified under NACE codes C26 or C27, the product complies with Directive 2009/125/EC and the implementing regulations adopted under that Directive.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The activity complies with the criteria set out in Appendix C to this Annex.

    Where the sold product is initially produced by the activities classified under NACE codes C29, and is a vehicle, mobility component, system, separate technical unit, part or a spare part as defined in Regulation (EU) 2018/858, it complies with the requirements of the most recent applicable stage of the Euro VI heavy duty emission type approval set out in accordance with Regulation (EC) No 595/2009 or with the requirements of the most recent applicable stage of the Euro 6 light-duty emission type-approval set out in accordance with Regulation (EC) No. 715/2007 or their successors. For road vehicles of categories M and N, tyres, except retreated tyres, comply with external rolling noise requirements in the highest populated class and with Rolling Resistance Coefficient (influencing the vehicle energy efficiency) in the two highest populated classes as set out in Regulation (EU) 2020/740 of the European Parliament and of the Council and as can be verified from the European Product Registry for Energy Labelling (EPREL), where applicable. Tyres comply with successors of Regulation (EC) No. 715/2007 and Regulation (EC) No 595/2009.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A

    5.5.Product-as-a-service and other circular use- and result-oriented service models

    Description of the activity

    Providing customers (physical person or legal person) with access to products through service models, which are either use-oriented services, where the product is still central, but its ownership remains with the provider and the product is leased, shared, rented or pooled; or result-oriented, where the payment is pre-defined and the agreed result (i.e. pay per service unit) is delivered.

    The economic activity covers products that are manufactured by economic activities classified under the NACE codes C13 Manufacture of textiles, C14 Manufacture of wearing apparel, C15 Manufacture of leather and related products, C16 Manufacture of wood and of products of wood and cork, except furniture; manufacture of articles of straw and plaiting materials, C22 Manufacture of rubber and plastic products, C23.3 Manufacture of clay building materials, C23.4 Manufacture of other porcelain and ceramic products, C25.1 Manufacture of structural metal products, C25.2 Manufacture of tanks, reservoirs and containers of metal, C25.7 Manufacture of cutlery, tools and general hardware, C25.9 Manufacture of other fabricated metal products, C26 Manufacture of computer, electronic and optical products, C27 Manufacture of electrical equipment, C28.22 Manufacture of lifting and handling equipment, C28.23 Manufacture of office machinery and equipment (except computers and peripheral equipment), C28.24 Manufacture of power-driven hand tools, C28.25 Manufacture of non-domestic cooling and ventilation equipment, C28.93 Manufacture of machinery for food, beverage and tobacco processing, excluding machinery for tobacco processing, C28.94 Manufacture of machinery for textile, apparel and leather production, C28.95 Manufacture of machinery for paper and paperboard production, C28.96 Manufacture of plastic and rubber machinery, C31 Manufacture of furniture and C32 Other manufacturing.

    The economic activities in this category could be associated with several NACE codes, in particular G46, G47, and N.77 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The activity provides the customer (physical or legal persons) with access to, and use of product(s), while ensuring that the ownership remains with the company providing this service, such as a manufacturer, specialist or retailer. The contractual terms and conditions ensure that all the following sub-criteria are met:

    (a)there is an obligation for the provider of the service to take back the used product at the end of the contractual agreement;

    (b)there is an obligation for the customer to give back the used product at the end of the contractual agreement;

    (c)the provider of the service remains owner of the product;

    (d)the customer pays for access to and use of the product, or the result of access to and use of this product.

    2. The activity leads to an extended lifespan or increased use intensity of the product in practice.

    4. Where the economic activity involves delivery of packaged products to customers (physical person or legal person) including when the activity is operated as an e-commerce 180 , the primary and secondary packaging of the product complies with one of the following criteria:

    (a)the packaging is made of at least 65% recycled material. Where the packaging is made from paper or cardboard, the remaining primary raw material are certified by the Forest Stewardship Council (FSC), the Programme for the Endorsement of Forest Certification Schemes (PEFC International), or equivalent recognised schemes. Coatings with plastics or metals are not used. For plastic packaging only monomaterials without coatings are used, halogen-containing polymers are not used. A declaration of compliance is provided specifying the material composition of the packaging and the shares of recycled and primary raw material;

    (b)the packaging has been designed to be reusable within a reuse system 181 . The system for reuse is established in a way that ensures the possibility of reuse in a closed-loop or open-loop system.

    4. For wearing apparel, where the economic activity involves laundry and dry-cleaning of used wearing apparel, the activity complies with an ISO type 1 ecolabel or equivalent.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the activity involves on-site generation of heat/cool or co-generation including power, the direct GHG emissions of the activity are lower than 270 gCO2e/kWh.

    The activity develops a strategy to account for and reduce the GHG emissions arising from the services upstream and downstream of the value chain, including:

    (a)intermediate products and raw materials;

    (b)transport along the value chain, including shipping and returns;

    (c)maintenance and operations, including laundry and cleaning;

    (d)end of life, including waste management.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The activity complies with the criteria set out in Appendix C to this Annex.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A

    5.6.Marketplace for the trade of second-hand goods for reuse

    Description of the activity

    Development and operation of marketplaces 182 and classifieds 183 for the trade (sale or exchange) of second-hand products, materials or components for reuse, where the marketplaces and classifieds act as an intermediary to match buyers seeking a service or product with sellers or providers of those products or services.

    The economic activity covers marketplaces and classifieds supporting B2B, B2C and Customer to Customer (C2C) sales. The activity covers services such as buyer-seller linking, payment or delivery service.

    The economic activity does not include the wholesale or retail trade of second-hand goods.

    The economic activity relates to products that are manufactured by economic activities classified under the NACE codes C10 Manufacture of food products, C11 Manufacture of beverages, C13 Manufacture of textiles, C14 Manufacture of wearing apparel, C15 Manufacture of leather and related products, C16 Manufacture of wood and of products of wood and cork, except furniture; manufacture of articles of straw and plaiting materials, C17 Manufacture of paper and paper products, C18 Printing and reproduction of recorded media, C22 Manufacture of rubber and plastic products, C23.3 Manufacture of clay building materials, C23.4 Manufacture of other porcelain and ceramic products, C24 Manufacture of basic metals, C25.1 Manufacture of structural metal products, C25.2 Manufacture of tanks, reservoirs and containers of metal, C25.7 Manufacture of cutlery, tools and general hardware, C25.9 Manufacture of other fabricated metal products, C26 Manufacture of computer, electronic and optical products, C27 Manufacture of electrical equipment, C28.22 Manufacture of lifting and handling equipment, C28.23 Manufacture of office machinery and equipment (except computers and peripheral equipment), C28.24 Manufacture of power-driven hand tools, C28.25 Manufacture of non-domestic cooling and ventilation equipment, C28.93 Manufacture of machinery for food, beverage and tobacco processing, excluding machinery for tobacco processing, C28.94 Manufacture of machinery for textile, apparel and leather production, C28.95 Manufacture of machinery for paper and paperboard production, C28.96 Manufacture of plastic and rubber machinery, C31 Manufacture of furniture and C32 Other manufacturing.

    The economic activities in this category could be associated with several NACE codes, in particular J58.29, J61, J62 and J63.1 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    An economic activity in this category is an enabling activity in accordance with Article 13(1), point (l), of Regulation (EU) 2020/852 where it complies with the technical screening criteria set out in this Section.

    Technical screening criteria

    Substantial contribution to the transition to a circular economy

    1. The economic activity consists of developing and operating marketplaces or classifieds to support the sale or reuse of second-hand products, components or materials.

    The activity enables the trade (sale or exchange) for reuse of second-hand goods as specified in the activity description that have already been used for their intended purpose before by a consumer or an organisation, with or without repair.

    2. Where servers and data storage products are being used:

    (a)the equipment used comply with the requirements for servers and data storage products set out in accordance with Directive 2009/125/EC; 

    (b)the equipment used does not contain the restricted substances listed in Annex II to Directive 2011/65/EU, except where the concentration values by weight in homogeneous materials do not exceed those listed in that Annex;

    (c)a waste management plan is in place to favour reuse as a priority and recycling at the end of life of electrical and electronic equipment, such as contractual agreements with recycling partners; 

    (d)at its end of life, equipment undergoes preparation for reuse, recovery or recycling operations, or proper treatment, including the removal of all fluids and a selective treatment in accordance with Annex VII to Directive 2012/19/EU.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where data centres are being used and operated, the activity has demonstrated best efforts to implement the relevant practices listed as ‘expected practices’ in the most recent version of the European Code of Conduct on Data Centre Energy Efficiency, or in CEN-CENELEC document CLC TR50600-99-1 ‘Data centre facilities and infrastructures - Part 99-1: Recommended practices for energy management’ 184 and has implemented all expected practices that have been assigned the maximum value of 5 according to the most recent version of the European Code of Conduct on Data Centre Energy Efficiency.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (5) Pollution prevention and control

    The activity complies with the criteria set out in Appendix C to this Annex.

    (6) Protection and restoration of biodiversity and ecosystems

    N/A



    Appendix A: Generic criteria for DNSH to climate change adaptation

    I. Criteria

    The physical climate risks that are material to the activity have been identified from those listed in the table in Section II of this Appendix by performing a robust climate risk and vulnerability assessment with the following steps:

    (a)    screening of the activity to identify which physical climate risks from the list in Section II of this Appendix may affect the performance of the economic activity during its expected lifetime;

    (b)    where the activity is assessed to be at risk from one or more of the physical climate risks listed in Section II of this Appendix, a climate risk and vulnerability assessment to assess the materiality of the physical climate risks on the economic activity;

    (c)    an assessment of adaptation solutions that can reduce the identified physical climate risk.

    The climate risk and vulnerability assessment is proportionate to the scale of the activity and its expected lifespan, such that:

    (a)    for activities with an expected lifespan of less than 10 years, the assessment is performed, at least by using climate projections at the smallest appropriate scale;

    (b)    for all other activities, the assessment is performed using the highest available resolution, state-of-the-art climate projections across the existing range of future scenarios 185 consistent with the expected lifetime of the activity, including, at least, 10 to 30 year climate projections scenarios for major investments.

    The climate projections and assessment of impacts are based on best practice and available guidance and take into account the state-of-the-art science for vulnerability and risk analysis and related methodologies in line with the most recent Intergovernmental Panel on Climate Change reports 186 , scientific peer-reviewed publications, and open source 187 or paying models.

    For existing activities and new activities using existing physical assets, the economic operator implements physical and non-physical solutions (‘adaptation solutions’), over a period of time of up to five years, that reduce the most important identified physical climate risks that are material to that activity. An adaptation plan for the implementation of those solutions is drawn up accordingly.

    For new activities and existing activities using newly-built physical assets, the economic operator integrates the adaptation solutions that reduce the most important identified physical climate risks that are material to that activity at the time of design and construction and has implemented them before the start of operations.

    The adaptation solutions implemented do not adversely affect the adaptation efforts or the level of resilience to physical climate risks of other people, of nature, of cultural heritage, of assets and of other economic activities; are consistent with local, sectoral, regional or national adaptation strategies and plans; and consider the use of nature-based solutions 188 or rely on blue or green infrastructure 189 to the extent possible.

    II. Classification of climate-related hazards 190

    Temperature-related

    Wind-related

    Water-related

    Solid mass-related

    Chronic

    Changing temperature (air, freshwater, marine water)

    Changing wind patterns

    Changing precipitation patterns and types (rain, hail, snow/ice)

    Coastal erosion

    Heat stress

    Precipitation or hydrological variability

    Soil degradation

    Temperature variability

    Ocean acidification

    Soil erosion

    Permafrost thawing

    Saline intrusion

    Solifluction

    Sea level rise

    Water stress

    Acute

    Heat wave

    Cyclone, hurricane, typhoon

    Drought

    Avalanche

    Cold wave/frost

    Storm (including blizzards, dust and sandstorms)

    Heavy precipitation (rain, hail, snow/ice)

    Landslide

    Wildfire

    Tornado

    Flood (coastal, fluvial, pluvial, ground water)

    Subsidence

    Glacial lake outburst



    Appendix B: Generic criteria for DNSH to sustainable use and protection of water and marine resources

    Environmental degradation risks related to preserving water quality and avoiding water stress are identified and addressed with the aim of achieving good water status and good ecological potential as defined in Article 2, points (22) and (23), of Regulation (EU) 2020/852, in accordance with Directive 2000/60/EC 191 and a water use and protection management plan, developed thereunder for the potentially affected water body or bodies, in consultation with relevant stakeholders.

    Where an Environmental Impact Assessment is carried out in accordance with Directive 2011/92/EU and includes an assessment of the impact on water in accordance with Directive 2000/60/EC, no additional assessment of impact on water is required, provided the risks identified have been addressed.

    The activity does not hamper the achievement of good environmental status of marine waters or does not deteriorate marine waters that are already in good environmental status as defined in point 5 of Article 3 of Directive 2008/56/EC 192 , taking into account the Commission Decision (EU) 2017/848 in relation to the relevant criteria and methodological standards for those descriptors.



    Appendix C: Generic criteria for DNSH to pollution prevention and control regarding use and presence of chemicals

    The activity does not lead to the manufacture, placing on the market or use of:

    (a) substances, whether on their own, in mixtures or in articles, listed in Annexes I or II to Regulation (EU) 2019/1021, except in the case of substances present as an unintentional trace contaminant;

    (b) mercury and mercury compounds, their mixtures and mercury-added products as defined in Article 2 of Regulation (EU) 2017/852;

    (c) substances, whether on their own, in mixture or in articles, listed in Annexes I or II to Regulation (EC) No 1005/2009;

    (d) substances, whether on their own, in mixtures or in an articles, listed in Annex II to Directive 2011/65/EU, except where there is full compliance with Article 4(1) of that Directive;

    (e) substances, whether on their own, in mixtures or in an article, listed in Annex XVII to Regulation (EC) 1907/2006, except where there is full compliance with the conditions specified in that Annex;

    (f) substances, whether on their own, or in mixtures or in an article, in a concentration above 0,1% weight by weight (w/w), and meeting the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 and that were identified in accordance with Article 59(1) of that Regulation for a period of at least 18 months, except if it is assessed and documented by the operators that no other suitable alternative substances or technologies are available on the market, and that they are used under controlled conditions 193

    In addition, the activity does not lead to the manufacture, presence in the final product or output, or placing on the market, of other substances, whether on their own, or in mixtures or in an article, in a concentration above 0,1% weight by weight (w/w), that meet the criteria of Regulation (EC) No 1272/2008 for one of the hazard classes or hazard categories mentioned in Article 57 of Regulation (EC) No 1907/2006, except if it is assessed and documented by the operators that no other suitable alternative substances or technologies are available on the market, and that they are used under controlled conditions 194 .

    Appendix D: Generic criteria for DNSH to protection and restoration of biodiversity and ecosystems

    An Environmental Impact Assessment (EIA) or screening 195 has been completed in accordance with Directive 2011/92/EU 196 .

    Where an EIA has been carried out, the required mitigation and compensation measures for protecting the environment are implemented.

    For sites/operations located in or near biodiversity-sensitive areas (including the Natura 2000 network of protected areas, UNESCO World Heritage sites and Key Biodiversity Areas, as well as other protected areas), an appropriate assessment 197 , where applicable, has been conducted and based on its conclusions the necessary mitigation measures 198 are implemented.

    (1)    Contact sensitive packaging’ means packaging that is intended to be used in any packaging applications in the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003 p. 29), Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4), Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1), Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1), Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176), Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1), Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67), or Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).
    (2)    ‘Reusable’ and ‘reuse system’ are defined and implemented in accordance with the requirements on packaging reuse systems in the Union legislation on packaging and packaging waste, including any standards related to the number of rotations in a system for reuse.
    (3)    The Commission will review these conditions once the revision of Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10) will be adopted.
    (4)    Sustainable bio-waste feedstock refers to industrial bio-waste and municipal bio-waste, it excludes primary biomass in the absence of legally agreed sustainability criteria.
    (5)    The Commission will review these conditions once the revision of Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10) will be adopted.
    (6)    ‘Unit of packaging’ means a unit as a whole, including any integrated or separate components, which together serve a packaging function such as the containment, protection, handling, delivery, storage, transport and presentation of products, and including independent units of grouped or transport packaging where they are discarded prior to the point of sale.
    (7)    ‘Recycling rate’ is the proportion of waste generated that is recycled.
    (8)    ISO 16290:2013, Space systems — Definition of the Technology Readiness Levels (TRLs) and their criteria of assessment (version of [adoption date]: https://www.iso.org/obp/ui/#iso:std:iso:16290:ed-1:v1:en) .  
    (9)    Regulation (EC) No 1272/2008 of the European Parliament and the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
    (10)    Commission Recommendation (EU) 2021/2279 of 15 December 2021 on the use of the Environmental Footprint methods to measure and communicate the life cycle environmental performance of products and organisations (OJ L 471, 30.12.2021, p. 1).
    (11)    ISO Standard 14067:2018, Greenhouse gases – carbon footprint of products – requirements and guidelines for quantification (version of [adoption date]: https://www.iso.org/standard/71206.html).
    (12)    ISO standard 14064-1:2018, Greenhouse gases — Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals (version of [adoption date]: https://www.iso.org/standard/66453.html).
    (13)    Commission Implementing Decision (EU) 2016/902 of 30 May 2016 establishing best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council, for common waste water and waste gas treatment/management systems in the chemical sector (OJ L 152, 9.6.2016, p. 23).
    (14)    Commission Implementing Decision (EU) 2022/2427 of 6 December 2022 establishing the best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions, for common waste gas management and treatment systems in the chemical sector (OJ L 318, 12.12.2022, p. 157).
    (15)    Best Available Techniques (BAT) Reference Document for the Production of Polymers (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/pol_bref_0807.pdf)
    (16)    Best Available Techniques (BAT) Reference Document for the Large Volumes Inorganic Chemicals- Solids and Others industry, (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic-s_bref_0907.pdf).
    (17)    Best Available Techniques (BAT) Reference Document for the manufacture of Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic_aaf.pdf ).  
    (18)    The Best Available Techniques Reference Document (BREF) for Manufacture of Organic Fine Chemicals (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/ofc_bref_0806.pdf).
    (19)    The Best Available Techniques Reference Document (BREF) for the production of speciality inorganic chemicals (SIC), (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/reference/production-speciality-inorganic-chemicals).
    (20)    Portable battery means any battery that is sealed and weighs less than or equal to 5kg and it is not designed for industrial purposes. Portable battery is neither an electric vehicle battery nor an automotive battery.
    (21)    Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L027 30.1.2010, p. 1).
    (22)    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (OJ L 117, 5.5.2017, p. 1).
    (23)    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (OJ L 117, 5.5.2017, p. 176).
    (24)    Reparability class’ means a class expressing the capacity of a good to be repaired, based on a method established in accordance with Union law [placeholder: Article XX of the Energy Labelling act].
    (25)    ‘Professional repairer’ means an operator or undertaking which provides services of repair and professional maintenance of products under this activity.
    (26)    Key spare parts are parts that are used for the repair or refurbishment of a defective product. For products covered by requirements on the availability of spare parts under Directive 2009/125/EC and implementing acts adopted under that Directive, key spare parts are considered to be those listed in Annex to the most recent implementing act for each product group.
    (27)    Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, p. 28).
    (28)    I4R Platform (version of [adoption date]: available at https://i4r-platform.eu/about/).
    (29)    Critical raw materials are defined as the elements listed in the EU Critical Raw Materials List (established through Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and The Committee of The Regions Critical Raw Materials Resilience: Charting a Path towards greater Security and Sustainability (COM/2020/474 final)) or other relevant Union legislation.
    (30)    Version of 16 June 2023; available at https://echa.europa.eu/scip-database.
    (31)    IEC 62474 - Material Declaration for Products of and for the Electrotechnical Industry.
    (32)    IEC 82474- Material declaration — Part 1: General requirements
    (33)    EN 45555:2019 General methods for assessing the recyclability and recoverability of energy-related products.
    (34)    Regulation (EU 2023/XX) of the European Parliament and of the Council concerning batteries and waste batteries, repealing Directive 2006/66/EC and amending Regulation (EU) No 2019/1020.
    (35)    Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, p. 195).
    (36)    The requirement targets the three highest classes of energy efficiency that are populated, in which at least some products are on the market. To understand which classes are the highest populated in which at least some products are on the market, an overview of the available products on the market (based on official data) is provided by European Product Database for Energy Labelling.
    (37)    Regulation (EU) 2017/1369 of the European Parliament and of the Council 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p.1).
    (38)    Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1).
    (39)    Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1)
    (40)    ‘Reclaimed Water’ means urban waste water that has been treated in compliance with the requirements set out in Directive 91/271/EEC and which results from further treatment in a reclamation plant.
    (41)    ‘Grey water’ means untreated waste water that has not been contaminated by any toilet discharge. Grey water includes waste water from bathtubs, showers, bathroom sinks, clothes washing machines and laundry sinks.
    (42)    Regulation (EU) 2020/741 of the European Parliament and of the Council of 25 May 2020 on minimum requirements for water reuse (OJ L 177, 5.6.2020, p. 32).
    (43)    For example, following IPCC guidelines for national GHG inventories for waste water treatment (version of [adoption date]: https://www.ipccnggip.iges.or.jp/public/2019rf/pdf/5_Volume5/19R_V5_6_Ch06_Wastewater.pdf)
    (44)    ‘Hazardous waste’ is waste which displays one or more of the hazardous properties listed in Annex III of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). It includes streams such as hazardous waste fractions produced by households, waste oils, batteries, non-depolluted waste from electrical and electronic equipment (WEEE), non-depolluted end-of-life vehicle, medical waste, etc. A comprehensive classification of hazardous waste can be found in the European List of Waste (Commission Decision 2000/532/EC).
    (45)    ‘Preparing for re-use’ means checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing.
    (46)    ‘Recycling’ means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.
    (47)    This includes textiles, clothes/wearing apparel, footwear, and accessories, such as belts or hats.
    (48)    Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
    (49)    See European Commission ‘Guidance for separate collection of municipal waste’, section 3.1 (Economic incentives), available at: https://op.europa.eu/en/publication-detail/-/publication/bb444830-94bf-11ea-aac4-01aa75ed71a1 .
    (50)    In accordance with Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).
    (51)    Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).
    (52)    Production processes refer to any kind of economic activity that produces a material, product or asset; recovered materials refer to the output of the recovery process.
    (53)    Commission Recommendation of 9 April 2013 on the use of common methods to measure and communicate the life cycle environmental performance of products and organisations (OJ L 124, 4.5.2013, p. 1).
    (54)    ISO 14067:2018(en), Greenhouse gases — Carbon footprint of products — Requirements and guidelines for quantification (version of [adoption date]: https://www.iso.org/obp/ui#iso:std:iso:14067:ed-1:v1:en).
    (55)    ISO 14064-1:2018(en), Greenhouse gases — Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals (version of [adoption date]: https://www.iso.org/obp/ui/#iso:std:iso:14064:-1:en).
    (56)    Commission Implementing Decision (EU) 2018/1147 of 10 August 2018 establishing best available techniques (BAT) conclusions for waste treatment, under Directive 2010/75/EU of the European Parliament and of the Council (OJ L 208, 17.8.2018, p. 38-90).
    (57)    Implementing Decision (EU) 2018/1147.
    (58)    EN 13432:2000 Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging.
    (59)    Implementing Decision (EU) 2018/1147.
    (60)    Implementing Decision (EU) 2018/1147.
    (61)    A substance, mixture or component is identifiable if it can be monitored to verify environmentally safe treatment.
    (62)    Commission Implementing Decision 2016/2323 establishing the European List of ship recycling facilities pursuant to Regulation (EU) No 1257/2013 of the European Parliament and of the Council on ship recycling (OJ L 345, 20.12.2016, p. 119).
    (63)    Regulation (EU) No 1257/2013 of the European Parliament and of the Council of 20 November 2013 on ship recycling and amending Regulation (EC) No 1013/2006 and Directive 2009/16/EC (OJ L 330, 10.12.2013, p. 1).
    (64)    At Union level, applicable requirements are set for WEEE by Directive 2012/19/EU and for ELVs by Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34).
    (65)    EN 50625-1:2014 Collection, logistics & Treatment requirements for WEEE - Part 1: General treatment requirements.
    (66)    EN 50625-2-1:2014 Collection, logistics and treatment requirements for WEEE - Part 2-1: Treatment requirements for lamps.
    (67)    EN 50625-2-2:2015 Collection, logistics & Treatment requirements for WEEE - Part 2-2: Treatment requirements for WEEE containing CRTs and flat panel displays.
    (68)    EN 50625-2-3:2017 Collection, logistics & treatment requirements for WEEE - Part 2-3: Treatment requirements for temperature exchange equipment and other WEEE containing VFC and/or VHC.
    (69)    EN 50625-2-4:2017 Collection, logistics & treatment requirements for WEEE - Part 2-4: Treatment requirements for photovoltaic panels.
    (70)    Implementing Decision (EU) 2018/1147.
    (71)    In accordance with Article 10(3) of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3) and with the national legislation and waste management plans.
    (72)    Implementing Decision (EU) 2018/1147.
    (73)    Implementing Decision (EU) 2018/1147.
    (74)    EU Construction and Demolition Waste Management Protocol, Annex F (version of [adoption date]: https://ec.europa.eu/docsroom/documents/20509/).
    (75)    ‘Preparing for re-use’ means checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing. This includes, for instance, the preparation for re-use of certain parts of buildings like roof elements, windows, doors, bricks, stones or concrete elements. A pre-requisite for the preparation for re-use of building elements is usually the selective deconstruction of buildings or other structures.
    (76)    ‘Recycling’ means any recovery operation, by which waste materials are reprocessed into products, materials or substances whether for the original or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.
    (77)    ‘Backfilling’ means any recovery operation where suitable non-hazardous waste is used for purposes of reclamation in excavated areas or for engineering purposes in landscaping. Waste used for backfilling must substitute non-waste materials, be suitable for the aforementioned purposes, and be limited to the amount strictly necessary to achieve those purposes.
    (78)    See Level(s) indicator 2.2: Construction and demolition waste and materials, User Manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.2_v1.1_40pp.pdf . For reporting, the Excel spreadsheet available on the Commission website is to be used: Construction and Demolition Waste (CDW) and materials excel template: for estimating (Level 2) and recording (Level 3) amounts and types of CDW and their final destinations (version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/product-groups/412/documents. 
    (79)    The GWP is communicated as a numeric indicator for each life cycle stage expressed as kgCO2e/m2 (of useful internal floor area) averaged for one year of a reference study period of 50 years. The data selection, scenario definition and calculations are carried out in accordance with EN 15978 (BS EN 15978:2011). The scope of building elements and technical equipment is as defined in the Level(s) common EU framework for indicator 1.2. Following the Level(s) indicator 1.2 reporting format, the indicator is communicated as GWP fossil, GWP biogenic, GWP land use and land use change, as well as the sum of these (GWP overall). Where a national calculation tool exists or is required for making disclosures or for obtaining building permits, the respective tool may be used to provide the required disclosure. Other calculation tools may be used if they fulfil the minimum criteria laid down by the Level(s) common EU framework, see Level(s) indicator 1.2: Lifecycle Global Warming Potential (GWP), User manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/sites/default/files/2021-01/UM3_Indicator_1.2_v1.1_37pp.pdf.
    (80)    See Level(s) indicator 2.3: Design for adaptability and renovation, User manual: introductory briefing, instruction and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.3_v1.1_23pp.pdf.
    (81)    See Level(s) indicator 2.4: Design for deconstruction user manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/sites/default/files/2021-01/UM3_Indicator_2.4_v1.1_18pp.pdf.
    (82)    For the purposes of the Delegated Act, ’secondary raw materials’ means materials that have been prepared for re-use or recycled in accordance with Article 3 of the Waste Framework Directive and have ceased to be waste under Article 6 of that Directive.
    (83)    This concerns the material concrete, including its constituent ingredients (for example, aggregates). Any steel reinforcement is excluded since this is a different material which can be accounted for under metals.
    (84)    Bio-based materials are made using biological resources (animals, plants, micro-organisms and derived biomass, including organic waste), as defined in COM(2018) 673. They include conventional bio-based materials made traditionally from biomass (such as wood, cork, natural rubber, paper, textiles, wooden construction materials) and more recently developed materials such as bio-based chemicals or bio-based plastics.
    (85)    See Level(s) indicator 2.1: Bill of Quantities, materials and lifespans, User manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.1_v1.1_34pp.pdf. For reporting, the Excel spreadsheet available on the Commission website is to be used: Bill of Quantities, materials and lifespans excel template: for estimating (Level 2) and recording (Level 3) purchases of material quantities and costs (version 1.2), https://susproc.jrc.ec.europa.eu/product-bureau/product-groups/412/documents.
    (86)    ISO standard 22057:2022, Sustainability in buildings and civil engineering works — Data templates for the use of environmental product declarations (EPDs) for construction products in building information modelling (BIM) (version of [adoption date]: https://www.iso.org/standard/72463.html). 
    (87)    The calculated amount of energy needed to meet the energy demand associated with the typical uses of a building expressed by a numeric indicator of total primary energy use in kWh/m2 per year and based on the relevant national calculation methodology and as displayed on the Energy Performance Certificate (EPC).
    (88)    Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13).
    (89)    Applying to paints and varnishes, ceiling tiles, floor coverings, including associated adhesives and sealants, internal insulation and interior surface treatments, such as those to treat damp and mold.
    (90)    CEN/TS 16516: 2013, Construction products - Assessment of release of dangerous substances -Determination of emissions into indoor air.
    (91)    ISO 16000-3:2011, Indoor air — Part 3: Determination of formaldehyde and other carbonyl compounds in indoor air and test chamber air — Active sampling method.
    (92)    The emissions thresholds for carcinogenic volatile organic compounds relate to a 28-day test period.
    (93)    ISO 18400 series on Soil quality — Sampling.
    (94)    JRC ESDCA, LUCAS: Land Use and Coverage Area frame Survey (version of [adoption date]: https://esdac.jrc.ec.europa.eu/projects/lucas).
    (95)    IUCN, The IUCN European Red List of Threatened Species (version of [adoption date]: https://www.iucn.org/regions/europe/our-work/biodiversity-conservation/european-red-list-threatened-species).
    (96)    IUCN, The IUCN Red List of Threatened Species (version of [adoption date]: https://www.iucnredlist.org).
    (97)    Land spanning more than 0,5 hectares with trees higher than five meters and a canopy cover of more than 10 %, or trees able to reach those thresholds in situ. It does not include land that is predominantly under agricultural or urban land use, FAO Global Resources Assessment 2020. Terms and definitions. (version of [adoption date]: http://www.fao.org/3/I8661EN/i8661en.pdf).
    (98)    EU Construction and Demolition Waste Management Protocol, Annex F (version of [adoption date]: https://ec.europa.eu/docsroom/documents/20509/).
    (99)    ‘Preparing for re-use’ means checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing. This includes, for instance, the preparation for re-use of certain parts of buildings like roof elements, windows, doors, bricks, stones or concrete elements. A pre-requisite for the preparation for re-use of building elements is usually the selective deconstruction of buildings or other structures.
    (100)    ‘Recycling’ means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.
    (101)    ‘Backfilling’ means any recovery operation where suitable non-hazardous waste is used for purposes of reclamation in excavated areas or for engineering purposes in landscaping. Waste used for backfilling must substitute non-waste materials, be suitable for the aforementioned purposes, and be limited to the amount strictly necessary to achieve those purposes.
    (102)    See Level(s) indicator 2.2: Construction and demolition waste and materials, User Manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.2_v1.1_40pp.pdf .  For reporting, the Excel spreadsheet available on the Commission website is to be used: Construction and Demolition Waste (CDW) and materials excel template: for estimating (Level 2) and recording (Level 3) amounts and types of CDW and their final destinations (version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/product-groups/412/documents .
    (103)    The GWP is communicated as a numeric indicator for each life cycle stage expressed as kgCO2e/m2 (of useful internal floor area) averaged for one year of a reference study period of 50 years. The data selection, scenario definition and calculations are carried out in accordance with EN 15978 (BS EN 15978:2011. Sustainability of construction works. Assessment of environmental performance of buildings. Calculation method). The scope of building elements and technical equipment is as defined in the Level(s) common EU framework for indicator 1.2. Where a national calculation tool exists, or is required for making disclosures or for obtaining building permits, the respective tool may be used to provide the required disclosure. Other calculation tools may be used if they fulfil the minimum criteria laid down by the Level(s) common EU framework, see Level(s) indicator 1.2: Lifecycle Global Warming Potential (GWP), User manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/sites/default/files/2021-01/UM3_Indicator_1.2_v1.1_37pp.pdf .
    (104)    See Level(s) indicator 2.3: Design for adaptability and renovation, User manual: introductory briefing, instruction and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.3_v1.1_23pp.pdf .
    (105)    See Level(s) indicator 2.4: Design for deconstruction user manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/sites/default/files/2021-01/UM3_Indicator_2.4_v1.1_18pp.pdf.
    (106)    International Property Measurement Standards: All Buildings. Published by the International Property Measurement Standards Coalition (IPMSC), https://ipmsc.org/.
    (107)    For the purposes of the Delegated Act, ’secondary raw materials’ means materials that have been prepared for re-use or recycled in accordance with Article 3 of the Waste Framework Directive and have ceased to be waste under Article 6 of that Directive.
    (108)    This concerns the material concrete, including its constituent ingredients (for example, aggregates). Any steel reinforcement is excluded since this is a different material which can be accounted for under metals.
    (109)    Bio-based materials are made using biological resources (animals, plants, micro-organisms and derived biomass, including organic waste), as defined in COM(2018) 673. They include conventional bio-based materials made traditionally from biomass (such as wood, cork, natural rubber, paper, textiles, wooden construction materials) and more recently developed materials such as bio-based chemicals or bio-based plastics.
    (110)    See Level(s) indicator 2.1: Bill of Quantities, materials and lifespans, User manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.1_v1.1_34pp.pdf. For reporting, the Excel spreadsheet available on the Commission website is to be used: Bill of Quantities, materials and lifespans excel template: for estimating (Level 2) and recording (Level 3) purchases of material quantities and costs (version 1.2), https://susproc.jrc.ec.europa.eu/product-bureau/product-groups/412/documents.
    (111)    ISO standard 22057:2022, Sustainability in buildings and civil engineering works — Data templates for the use of environmental product declarations (EPDs) for construction products in building information modelling (BIM) (version of April 2022), https://www.iso.org/standard/72463.html .  
    (112)    Applying to paints and varnishes, ceiling tiles, floor coverings (including associated adhesives and sealants), internal insulation and interior surface treatments, such as to treat damp and mould.
    (113)    ISO 16000-3:2011, Indoor air — Part 3: Determination of formaldehyde and other carbonyl compounds in indoor air and test chamber air — Active sampling method (version of [adoption date]: https://www.iso.org/standard/51812.html).
    (114)    See activities listed by the International Cost Management Standard in the ‘ICMS: Global Consistency in Presenting Construction Life Cycle Costs and Carbon Emissions 3rd edition, Table 1: ICMS Projects with their corresponding codes’, https://icmscblog.files.wordpress.com/2021/11/icms_3rd_edition_final.pdf.
    (115)    See Level(s) indicator 2.2: Construction and Demolition waste and materials, User manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.2_v1.1_40pp.pdf
    (116)    Guidelines for the waste audits before demolition and renovation works of buildings. EU Construction and Demolition Waste Management, May 2018: https://ec.europa.eu/docsroom/documents/31521/attachments/1/translations/en/renditions/native. For reporting the estimates of Level 2 Demolition Waste, the Excel spreadsheet available on the Commission website is to be used: Construction and Demolition Waste (CDW) and materials excel template: for estimating (Level 2) and recording (Level 3) amounts and types of CDW and their final destinations (version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/product-groups/412/documents.
    (117)     Guidelines for the waste audits before demolition and renovation works of buildings. EU Construction and Demolition Waste Management, May 2018: https://ec.europa.eu/docsroom/documents/31521/attachments/1/translations/en/renditions/native. For reporting the estimates of Level 3 Construction and Demolition Waste, the Excel spreadsheet available on the Commission website is to be used: Construction and Demolition Waste (CDW) and materials excel template: for estimating (Level 2) and recording (Level 3) amounts and types of CDW and their final destinations (version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/product-groups/412/documents. For this, each type of demolition waste is tagged with the appropriate six-digit code from the European List of Waste established by Commission Decision 2000/532/EC. When including the type of waste treatment in the Excel spreadsheet (i.e. preparation for reuse, for recycling, material recovery, energy recovery or disposal), evidence is included that the economic operators receiving the waste have the technical capability to carry out this treatment. Such evidence may consist in a link to the company’s webpages where this is documented or a signed statement from a representative of the company. Where the treatment takes place on the demolition site, such as onsite reuse or recycling, acceptable evidence may consist in a signed statement from a representative of the company.
    (118)    ‘Preparing for re-use’ means checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing. This includes, for instance, the preparation for re-use of certain parts of buildings like roof elements, windows, doors, bricks, stones or concrete elements. A pre-requisite for the preparation for re-use of building elements is usually the selective deconstruction of buildings or other structures.
    (119)    ‘Recycling’ means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.
    (120)    ‘Backfilling’ means any recovery operation where suitable non-hazardous waste is used for purposes of reclamation in excavated areas or for engineering purposes in landscaping. Waste used for backfilling must substitute non-waste materials, be suitable for the aforementioned purposes, and be limited to the amount strictly necessary to achieve those purposes.
    (121)    See Level(s) indicator 2.2: Construction and demolition waste and materials, User Manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.2_v1.1_40pp.pdf
    (122)    See Annex III to Commission Regulation 849/2010 for a categorisation of mineral non-hazardous construction and demolition waste, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010R0849&from=EN
    (123)    Serviceability’ refers to the conditions under which a built asset is still considered safe to use.
    (124)    Level of service’ refers to a qualitative or quantitative measure to assess the infrastructure’s ability to cater to the traffic demands placed on it.
    (125)    Service life’ refers to the period of use in service, i.e. from the date of construction until the date of reconstruction or demolition.
    (126)    ‘Preparing for re-use’ means checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing. This includes, for instance, the preparation for re-use of certain parts of buildings like roof elements, windows, doors, bricks, stones or concrete elements. A pre-requisite for the preparation for re-use of building elements is usually the selective deconstruction of buildings or other structures.
    (127)    ‘Recycling’ means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.
    (128)    ‘Backfilling’ means any recovery operation where suitable non-hazardous waste is used for purposes of reclamation in excavated areas or for engineering purposes in landscaping. Waste used for backfilling must substitute non-waste materials, be suitable for the aforementioned purposes, and be limited to the amount strictly necessary to achieve those purposes.
    (129)    Commission Staff Working Document. EU Green Public Procurement Criteria for Road Design, Construction and Maintenance (SWD(2016) 203), 2016, p.17, column ‘comprehensive criteria’, (version of [adoption date]: https://ec.europa.eu/environment/gpp/pdf/toolkit/roads/EN.pdf).
    (130)    For the purposes of the Delegated Act, ’secondary raw materials’ means materials that have been prepared for re-use or recycled in accordance with Article 3 of the Waste Framework Directive and have ceased to be waste under Article 6 of that Directive.
    (131)    Commission Staff Working Document. EU Green Public Procurement Criteria for Road Design, Construction and Maintenance (SWD(2016) 203), 2016, p.15, column ‘comprehensive criteria’, (version of [adoption date]: https://ec.europa.eu/environment/gpp/pdf/toolkit/roads/EN.pdf).
    (132)    Maintenance of civil engineering objects’ is defined as all actions undertaken to maintain and restore the serviceability and level of service of roads.
    (133)    EU Construction and Demolition Waste Management Protocol, Annex F (version of [adoption date]: https://ec.europa.eu/docsroom/documents/20509/).
    (134)    ‘Preparing for re-use’ means checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing. This includes, for instance, the preparation for re-use of certain parts of buildings like roof elements, windows, doors, bricks, stones or concrete elements. A pre-requisite for the preparation for re-use of building elements is usually the selective deconstruction of buildings or other structures.
    (135)    ‘Recycling’ means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.
    (136)    ‘Backfilling’ means any recovery operation where suitable non-hazardous waste is used for purposes of reclamation in excavated areas or for engineering purposes in landscaping. Waste used for backfilling must substitute non-waste materials, be suitable for the aforementioned purposes, and be limited to the amount strictly necessary to achieve those purposes.
    (137)    See Level(s) indicator 2.3: Design for adaptability and renovation, User manual: introductory briefing, instruction and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau//sites/default/files/2021-01/UM3_Indicator_2.3_v1.1_23pp.pdf .
    (138)    See Level(s) indicator 2.4: Design for deconstruction user manual: introductory briefing, instructions and guidance (Publication version 1.1), https://susproc.jrc.ec.europa.eu/product-bureau/sites/default/files/2021-01/UM3_Indicator_2.4_v1.1_18pp.pdf .
    (139)    For the purposes of the Delegated Act, ’secondary raw materials’ means materials that have been prepared for re-use or recycled in accordance with Article 3 of the Waste Framework Directive and have ceased to be waste under Article 6 of that Directive.
    (140)    ISO standard 22057:2022, Sustainability in buildings and civil engineering works — Data templates for the use of environmental product declarations (EPDs) for construction products in building information modelling (BIM) (version of April 2022), https://www.iso.org/standard/72463.html .  
    (141)    Calculated in accordance with Regulation (EU) 2019/331.
    (142)    Reflecting the median value of the installations in 2016 and 2017 (t CO2 equivalents/t) of the data collected in the context of establishing the Commission Implementing Regulation (EU) 2021/447, determined on the basis of verified information on the greenhouse gas efficiency of installations reported pursuant to Article 11 of Directive 2003/87/EC.
    (143)    Reflecting the median value of the installations in 2016 and 2017 (t CO2 equivalents/t) of the data collected for grey cement clinker in the context of establishing the Commission Implementing Regulation (EU) 2021/447, multiplied by the clinker to cement ratio (0.65), determined on the basis of verified information on the greenhouse gas efficiency of installations reported pursuant to Article 11 of Directive 2003/87/EC.
    (144)    Applying to paints and varnishes, ceiling tiles, floor coverings, including associated adhesives and sealants, internal insulation and interior surface treatments, such as those to treat damp and mold.
    (145)    CEN/TS 16516: 2013, Construction products - Assessment of release of dangerous substances -Determination of emissions into indoor air.
    (146)    ISO 16000-3:2011, Indoor air — Part 3: Determination of formaldehyde and other carbonyl compounds in indoor air and test chamber air — Active sampling method.
    (147)    The emissions thresholds for carcinogenic volatile organic compounds relate to a 28-day test period.
    (148)    Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise - Declaration by the Commission in the Conciliation Committee on the Directive relating to the assessment and management of environmental noise (OJ L 189, 18.7.2002, p. 12).
    (149)    Software’ includes on-premise and cloud-based software.
    (150)    IT or OT systems’ include connectable products, sensors, analytics and other software, and information and communication technologies (ICT) for the transmission, storage and display of data and system management.
    (151)    ‘Consumables’ are non-durable commodities that are intended to be used, depleted or replaced. They may be required for the functioning of a consumer product, or be used in fabrication, without being incorporated into the finished product.
    (152)    ISO standard 14067:2018, Greenhouse gases — Carbon footprint of products — Requirements and guidelines for quantification (version of [adoption date]: https://www.iso.org/standard/71206.html).
    (153)    ISO standard 14040:2006, Environmental management — Life cycle assessment — Principles and framework (version of [adoption date]: https://www.iso.org/standard/37456.html).
    (154)    ISO standard 14067:2018, Greenhouse gases — Carbon footprint of products — Requirements and guidelines for quantification (version of [adoption date]: https://www.iso.org/standard/71206.html).
    (155)    ISO standard 14040:2006, Environmental management — Life cycle assessment — Principles and framework (version of [adoption date]: https://www.iso.org/standard/37456.html).
    (156)    Minimum information include energy labelling requirements under Union’s energy labelling framework regulation, information under the scope of Regulation (EC) No 1272/2008, information on the Substances of Very High Concern in articles as such or in complex objects (Products) established under Directive 2008/98/EC or information on safety or warranty.
    (157)    ‘Circularity performance’ is to be assessed on the basis of: i) product durability, reliability, reusability, upgradability, reparability, ease of maintenance and refurbishment; ii) presence of substances that inhibit the circularity of products and materials; iii) energy use or energy efficiency of products; iv) resource use or resource efficiency of products; v) recycled content in products; vi) ease of disassembly, remanufacturing and recycling of products and materials; vii) life-cycle environmental impact of products, including their carbon and environmental footprints; viii) preventing and reducing waste, including packaging waste.
    (158)    ‘Repair’ means the process of returning a faulty product to a condition where it can fulfil its intended use, either as a service or with a view to the subsequent resale of the repaired product.
    (159)    ‘Refurbishment’ means testing and where necessary repairing, cleaning or modifying a used product to increase or restore its performance or functionality or to meet applicable technical standards or regulatory requirements, with the result of making a fully functional product to be used for a purpose that is at least the one that was originally intended and to maintain its compliance with applicable technical standards or regulatory requirements originally conceived at the design stage.
    (160)    ‘Remanufacturing’ means a standardised industrial process that takes place within industrial or factory settings, in which products are restored to original as-new condition and performance or better, typically placed on the market with a commercial guarantee.
    (161)    Goods, components or materials that must be replaced regularly because they either wear out or are used up.
    (162)    The conformity of the product and the period of liability of the seller are set in accordance with the relevant provisions of Directive (EU) 2019/771.
    (163)    Directive (EU) 2017/2102 of the European Parliament and of the Council of 15 November 2017 amending Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 305, 21.11.2017, p. 8).
    (164)    ‘Spare part’ means a separate part of a product that can replace a part of a product with the same or similar function. The product cannot function as intended without that part of the product. The functionality of a product is restored or is upgraded when the part is replaced by a spare part in line with Directive 2011/65/EU. Spare parts may be used parts.
    (165)    The conformity of the product and the period of liability of the seller are set in accordance with the relevant provisions of Directive (EU) 2019/771.
    (166)    ‘E-commerce’ can be defined generally as the sale or purchase of goods or services, whether between businesses, households, individuals or private organizations, through electronic transactions conducted via the internet or other computer-mediated (online communication) networks, see Eurostat Statistics Explained Glossary, available at https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Category:Glossary.
    (167)    ‘Reusable’ and ‘reuse system’ are defined and implemented in accordance with the requirements on packaging reuse systems in the Union legislation on packaging and packaging waste, including any standards related to the number of rotations in a system for reuse.
    (168)    Preparing for re-use is an operation or set of operations by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing. It is the highest waste treatment option on the waste hierarchy (after waste prevention).
    (169)    In the Union, the activity is in line with Article 10(3) of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3), or sectoral Union legislation related to waste and the national legislation and waste management plans.
    (170)    The conformity of the product and the period of liability of the seller are set in accordance with the relevant provisions of Directive (EU) 2019/771.
    (171)    ISO 14001:2015, Environmental management systems — Requirements with guidance for use, (version of [adoption date]: https://www.iso.org/standard/60857.html).
    (172)    Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission Decisions 2001/681/EC and 2006/193/EC (OJ L 342, 22.12.2009, p. 1).
    (173)    ISO 9001:2015, Quality management systems — Requirements (version of [adoption date]: https://www.iso.org/standard/62085.html).
    (174)    The conformity of the product and the period of liability of the seller are set in accordance with the relevant provisions of Directive (EU) 2019/771.
    (175)    ‘E-commerce’ can be defined generally as the sale or purchase of goods or services, whether between businesses, households, individuals or private organizations, through electronic transactions conducted via the internet or other computer-mediated (online communication) networks, see Eurostat Statistics Explained Glossary, available at https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Category:Glossary.
    (176)    ‘Reusable’ and ‘reuse system’ are defined and implemented in accordance with the requirements on packaging reuse systems in the Union legislation on packaging and packaging waste, including any standards related to the number of rotations in a system for reuse.
    (177)    Regulation (EU) 2019/631 of the European Parliament and of the Council of 17 April 2019 setting CO2 emission performance standards for new passenger cars and for new light commercial vehicles, and repealing Regulations (EC) No 443/2009 and (EU) No 510/2011 (recast) (OJ L 111, 25.4.2019, p. 13).
    (178)    As defined in Article 4 of Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
    (179)    Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
    (180)    ‘E-commerce’ can be defined generally as the sale or purchase of goods or services, whether between businesses, households, individuals or private organizations, through electronic transactions conducted via the internet or other computer-mediated (online communication) networks, see Eurostat Statistics Explained Glossary, available at https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Category:Glossary.
    (181)    ‘Reusable’ and ‘reuse system’ are defined and implemented in accordance with the requirements on packaging reuse systems in the Union legislation on packaging and packaging waste, including any standards related to the number of rotations in a system for reuse.
    (182)    Marketplaces’ are platforms that connect buyers and sellers and facilitate transaction via technology enablement or services, such as payment gateway or logistics services.
    (183)    ‘Classifieds’ are platforms that connect buyers and sellers.
    (184)    Issued on 1 July 2019 by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), (version of [adoption date]: https://www.cenelec.eu/dyn/www/f?p=104:110:508227404055501::::FSP_ORG_ID,FSP_PROJECT,FSP_LANG_ID:1258297,65095,25).
    (185)    Future scenarios include Intergovernmental Panel on Climate Change representative concentration pathways RCP2.6, RCP4.5, RCP6.0 and RCP8.5.
    (186)    Assessments Reports on Climate Change: Impacts, Adaptation and Vulnerability, published periodically by the Intergovernmental Panel on Climate Change (IPCC), the United Nations body for assessing the science related to climate change produces, https://www.ipcc.ch/reports/.
    (187)    Such as Copernicus services managed by the European Commission.
    (188)    Nature-based solutions are defined as ‘solutions that are inspired and supported by nature, which are cost-effective, simultaneously provide environmental, social and economic benefits and help build resilience. Such solutions bring more, and more diverse, nature and natural features and processes into cities, landscapes and seascapes, through locally adapted, resource-efficient and systemic interventions’. Therefore, nature-based solutions benefit biodiversity and support the delivery of a range of ecosystem services (version of [adoption date]: https://ec.europa.eu/research/environment/index.cfm?pg=nbs ).
    (189)    See Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Green Infrastructure (GI) — Enhancing Europe’s Natural Capital (COM/2013/0249 final).
    (190)    The list of climate-related hazards in this table is non-exhaustive, and constitutes only an indicative list of most widespread hazards that are to be taken into account as a minimum in the climate risk and vulnerability assessment.
    (191)    For activities in third countries, in accordance with applicable national law or international standards which pursue equivalent objectives of good water status and good ecological potential, through equivalent procedural and substantive rules, i.e. a water use and protection management plan developed in consultation with relevant stakeholders which ensures that 1) the impact of the activities on the identified status or ecological potential of potentially affected water body or bodies is assessed and 2) deterioration or prevention of good status/ecological potential is avoided or, where this is not possible, 3) justified by the lack of better environmental alternatives which are not disproportionately costly/technically unfeasible, and all practicable steps are taken to mitigate the adverse impact on the status of the body of water.
    (192)    The definition laid down in point 5 of Article 3 of Directive 2008/56/EC provides in particular that good environmental status is to be determined on the basis of the qualitative descriptors laid down in Annex I to that Directive.
    (193)    The Commission will review the exceptions from the prohibition from manufacturing, placing on the market or use of the substances referred to in point (f) once it will have published horizontal principles on essential use of chemicals.
    (194)    The Commission will review the exceptions from the prohibition from manufacture, presence in the final product or output, or placing on the market of the substances referred to in this paragraph once it will have published horizontal principles on essential use of chemicals.
    (195)    The procedure through which the competent authority determines whether projects listed in Annex II to Directive 2011/92/EU is to be made subject to an environmental impact assessment (as referred to in Article 4(2) of that Directive).
    (196)    For activities in third countries, in accordance with equivalent applicable national law or international standards requiring the completion of an EIA or screening, for example, IFC Performance Standard 1: Assessment and Management of Environmental and Social Risks.
    (197)    In accordance with Directives 2009/147/EC and 92/43/EEC. For activities located in third countries, in accordance with equivalent applicable national law or international standards, that aim at the conservation of natural habitats, wild fauna and wild flora, and that require to carry out (1) a screening procedure to determine whether, for a given activity, an appropriate assessment of the possible impacts on protected habitats and species is needed; (2) such an appropriate assessment where the screening determines that it is needed, for example IFC Performance Standard 6: Biodiversity Conservation and Sustainable Management of Living Natural Resources.
    (198)    Those measures have been identified to ensure that the project, plan or activity will not have any significant effects on the conservation objectives of the protected area.
    Top

    TABLE OF CONTENTS

    ANNEX III    2

    1.Manufacturing2

    1.1.Manufacture of active pharmaceutical ingredients (API) or active substances2

    1.2.Manufacture of medicinal products8

    2.Water supply, sewerage, waste management and remediation activities 14

    2.1.Collection and transport of hazardous waste14

    2.2.Treatment of hazardous waste 16

    2.3.Remediation of legally non-conforming landfills and abandoned or illegal waste dumps20

    2.4.Remediation of contaminated sites and areas25

    ANNEX III

    Technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to pollution prevention and control and for determining whether that economic activity causes no significant harm to any of the other environmental objectives

    1.Manufacturing

    1.1.Manufacture of active pharmaceutical ingredients (API) or active substances

    Description of the activity

    Manufacture of active pharmaceutical ingredients (API) or active substances.

    The economic activities in this category could be associated with NACE code C21.1 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to pollution prevention and control

    1. The activity complies with all of the requirements specified below relating to product substitution.

    1.1. The API complies with one of the following requirements:

    (a)the API is a naturally occurring substance, such as vitamins, electrolytes, amino acids, peptides, proteins, nucleotides, carbohydrates and lipids a and, in line with the European Medicines Agency Guideline on the environmental risk assessment of medicinal products for human use (EMA ERA guideline) 1 , is generally considered to be degradable in the environment 2 ;

    (b)where the API does not comply with the requirements specified in point (a), the API, its key human metabolites and its key transformation products in the environment comply with one of the following:

    (i)are classified as readily biodegradable based on at least one of the test methods from the OECD Guidelines for the Testing of Chemicals, Test 301 (A-F), Ready Biodegradability 3 , in accordance with the pass value for ready biodegradability as defined in that guideline;

    (ii)can be concluded to be mineralised based on a specific Test No. 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems (OECD 308) 4 of the OECD Guidelines for the Testing of Chemicals 5 compared to persistence criteria as defined in the EMA ERA guideline.

    1.2. The API qualifies as an appropriate substitute to another API, within the same therapeutic area or the substance class, that is available in the market or was available during last 5 years and that does not comply with the requirements described in point 1.1.

    Compliance with this requirement is demonstrated through a publicly available analysis verified by an independent third party.

    1.3. The manufacturing process of the API does not involve the use of substances, whether on their own or in mixtures, that meet the criteria set out in Article 57 of Regulation (EC) 1907/2006 except where it is assessed and documented by the operator that no other suitable alternative substances or technologies are available on the market, and that they are used under controlled conditions 6 .

    2. The activity complies with the following requirements regarding the emission of pollutants:

    2.1. Where the activity falls within its scope, the emission limit values are lower than the mid-point of the BAT-AEL ranges 7 set out in:

    (a)the best available techniques (BAT) conclusions for common waste gas management and treatment systems in the chemical sector for emissions to air of new installations (or for existing installations within 4 years of the BATC publication) where relevant conditions apply 8 ;

    (b)the Best Available Techniques Reference Document (BREF) for Manufacture of Organic Fine Chemicals (OFC) 9  for the manufacturing activity under conditions not covered by the BATC mentioned above;

    (c)the best available techniques (BAT) conclusions for common waste water and waste gas treatment/management systems in the chemical sector 10 ;

    (d)the Best Available Techniques Reference Document (BREF) for the Large Volume Inorganic Chemicals – Solids and Others industry 11 ;

    (e)the Best Available Techniques Reference Document (BREF) for the manufacture of Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers 12 ;

    (f)the Best Available Techniques Reference Document (BREF) for the production of speciality inorganic chemicals (SIC) 13 ; for the manufacturing activity under conditions not covered by the BATC mentioned above.

    Plants within the BAT-AEL range(s) moving to the mid-point ambition do not trigger any significant cross-media impact. Installations that have been granted a derogation in accordance with the procedure set out in Article 15(4) of Directive 2010/75/EU are not considered as fulfilling the technical screening criteria for the period of the derogation.

    2.2. Where a continuous measurement methodology for a certain pollutant is available, the operator applies Continuous Emission Monitoring Systems (CEMS), Continuous Effluent Quality Monitoring Systems (CEQMS) and other measures ensuring the regular verification of non-deterioration of environment.

    2.3. The operator applies solvent waste segregation for solvent recovery from concentrated waste streams, where technically applicable.

    Solvents included in Table 1 of the European Medicines Agency ICH guideline Q3C (R8) on impurities: guideline for residual solvents 14 are avoided.

    The maximum solvents loss from total inputs does not exceed a 3% loss. Total volatile organic compound (VOC) recovery efficiency is at least 99%.

    The operator verifies that no fugitive VOC emission occurs beyond the criteria specified below as to the parts per million volumetric (ppmv) thresholds by carrying out Leak detection and repair (LDAR) campaigns, at least every 3 years. Investments for the use of high integrity equipment are recommended, provided that these are installed in existing plants for cases mentioned under BAT 23 point b of the best available techniques (BAT) conclusions for common waste gas management and treatment systems in the chemical sector (WGC), whereas the pressure threshold is brought to 200 bar. The minimal verification schedule may be reduced in cases where quantification of total VOC emissions from the plant is periodically qualified with tracer correlation (TC) or with optical absorption-based techniques, such as differential absorption light detection and ranging (DIAL) or solar occultation flux (SOX) or other measures of equivalent performance.

    Diffuse emissions of substances or mixtures classified as CMR1A or 1B from leaky equipment do not exceed a concentration of 100 ppmv 15 .

    The LDAR campaigns have the features described in BAT19 of the best available techniques (BAT) conclusions for common waste gas management and treatment systems in the chemical sector, which include detecting, repairing and maintaining leaks within 30 days of detection and a leak threshold that is lower than or equal to 5000 ppmv for substances or mixtures other than those classified as CMR 1A or 1B, which are reviewed and updated for the continuous improvement of the installation. Solvent losses and recovery efficiency of VOC are monitored based on a solvent management plan using a mass balance for verification of compliance, in accordance with Chapter V of Directive 2010/75/EU.

    2.4. Sewage, refuse, and other waste (including solids, liquids, or gaseous by-products from manufacturing) are disposed of in a safe, timely, and sanitary manner. Containers or pipes for waste material are clearly identified. Analytical data demonstrating the conversion of these substances and their residues to non-hazardous waste materials are available at the facility and kept up to date.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the activity involves on-site generation of heat/cool or co-generation including power, the direct GHG emissions of the activity are lower than 270 gCO2e/kWh.

    For the refrigerant threshold, the Global Warming Potential does not exceed 150 in cooling of the substance.

    Where active pharmaceutical ingredients (API) or active substances are made from substances listed in Sections 3.10 to 3.16 of Annex II to Commission Delegated Regulation (EU) 2021/2139, the GHG emissions do not exceed the limits set out in their respective criteria for DNSH to climate change mitigation.

    The substitution does not lead to an increment of lifecycle GHG emissions. Lifecycle GHG emissions are calculated using Recommendation 2013/179/EU or, alternatively, using ISO 14067:2018 16 or ISO 14064-1:2018 17 . Quantified life-cycle GHG emissions are verified by an independent third party.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    1. Waste water treatment:

    The performance of wastewater treatment processes conducted by or on behalf of the manufacturing plant does not lead to any deterioration of water bodies and marine resources.

    When activities fall within their scope, they meet the requirements of Directives 91/271/EEC, 2008/105/EC, 2006/118/EC, 2010/75/EU, 2000/60/EC, (EU) 2020/2184, 76/160/EEC, 2008/56/EC and 2011/92/EU.

    The activity implements best practices specified in the Joint Research Centre Best Environmental Management Practice for the Public Administration Sector 18 .

    Where waste water treatment is conducted by an urban wastewater treatment plant on behalf of the manufacturing plant, it is ensured that:

    (a)the load of pollutants released by the manufacturing plant has no negative effect in the treatment process of the urban waste water treatment plant;

    (b)the load and characteristics of pollutants do not pose any risk or harm to the health of the staff working in waste water treatment plants;

    (c)the urban waste water treatment plant is designed and equipped appropriately to abate the released polluting substances;

    (d)the overall load of the concerned pollutants discharged to the water body is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set for direct releases;

    (e)the usability of the sewage sludge for nutrient (re)cycling is not affected.

    For installations where additional pollutant limits or stricter conditions have been included in their environmental permit compared to the requirements of the legislation mentioned above, these stricter conditions apply.

    2. Soil and groundwater protection:

    Appropriate measures are in place to prevent emissions to soil and regular surveillance is conducted to avoid leaks, spills, incidents or accidents occurring during the use of equipment and during storage.

    3. Water Consumption:

    Operators assess the water footprint of the chemical production processes in line with ISO 14046:2014 19 and ensure that they do not contribute to water scarcity. Based on this assessment, operators provide a declaration that they do not contribute to water scarcity which is verified by an independent third party.

    4. The activity complies with the criteria set out in Appendix B to this Annex.

    (4) Transition to a circular economy

    The activity assesses the availability of and, where feasible, adopts techniques that support:

    (a)reuse and use of secondary raw materials and reused components in products manufactured;

    (b)design for high durability, recyclability, easy disassembly and adaptability of products manufactured;

    (c)waste management that prioritises recycling over disposal, in the manufacturing process;

    (d)information on product ingredients along the supply chain.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    1.2.Manufacture of medicinal products

    Description of the activity

    Manufacture of medicinal products.

    The economic activities in this category could be associated with NACE code C21.2 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to pollution prevention and control

    1. The activity complies with one of the following sets of requirements set out in point 1.1. or 1.2. relating to product substitution. In any case, the activity complies with the requirements set out in point 1.3.

    1.1. The medicinal product complies with the following requirements set out in points 1.1.1. and 1.1.2.:

    1.1.1. The medicinal product complies with one of the following requirements:

    (a)the ingredients that constitute the formulation of the medicinal product are naturally occurring substances such as vitamins, electrolytes, amino acids, peptides, proteins, nucleotides, carbohydrates and lipids and, in line with European Medicines Agency Guideline on the environmental risk assessment of medicinal products for human use (EMA ERA guideline) 20 , are generally considered to be degradable in the environment 21 ;

    (b)where the ingredients that constitute the formulation of the medicinal product do not comply with the requirements specified in point (a), those ingredients, their key human metabolites and their key transformation products in the environment comply with one of the following:

    (i)are classified as readily biodegradable based on at least one of the test methods from the OECD Guidelines for the Testing of Chemicals, Test 301 (A-F), Ready Biodegradability 22 , in accordance with the pass value for ready biodegradability as defined in that guideline;

    (ii)can be concluded to be mineralised based on a specific Test No. 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems (OECD 308) 23 of OECD Guidelines for the Testing of Chemicals 24 compared to persistence criteria as defined in the EMA ERA guideline.

    1.1.2. The medicinal product qualifies as an appropriate substitute to another medicinal product, within the same therapeutic area or the substance class, that is available in the market or was available during last 5 years and that does not comply with the requirements described in point 1.1.1.

    Compliance with this requirement is demonstrated through a publicly available analysis verified by an independent third party.

    1.2. The manufacturer proves that there are no ingredients to produce an alternative medicinal product that qualifies as an appropriate substitute, within the same therapeutic area or the substance class, that comply with the requirements described in point 1.1.1. The activity complies with all the requirements specified in points 1.2.1 to 1.2.6.

    1.2.1. The manufacturer performs an analysis that there is no appropriate substitute to the produced medicinal product, publishes the core results of that analysis and demonstrates that they started initiatives to develop that alternative.

    1.2.2. In line with the EMA ERA guidelines, the PEC/PNEC ratio for the medicinal product obtained in the Environmental Risk Assessment is below 1.

    1.2.3. Packaging and distribution systems allow adjusting the sold amount to the required amount by the treatment/s, taking into account the applicable national legislation.

    1.2.4. Public information, such as leaflets or websites, updated according to the state of the art, is provided about dose and dosing method to minimize the excess of dosed API.

    1.2.5. Packaging and distribution systems allow using the most efficient dosing system available according to the state of the art and considering the kind of administration, such as by health care professionals or domestic. The manufacturer publishes the main results of that analysis.

    1.2.6. The manufacturer contributes to mitigating the environmental impact of incorrect waste disposal of unused medicinal product, including by providing relevant information to the downstream users on appropriate disposal of unused medicinal product.

    1.3. The manufacturing process does not involve the use of substances, whether on their own or in mixtures, that meet the criteria set out in Article 57 of Regulation (EC) 1907/2006 except where it is assessed and documented by the operator that no other suitable alternative substances or technologies are available on the market, and that they are used under controlled conditions 25 .

    2. The activity complies with the following requirements regarding the emission of pollutants:

    2.1. Where the activity falls within its scope, the emission limit values shall be lower than the mid-point of the BAT-AEL ranges 26 set out in:

    (a)the best available techniques (BAT) conclusions for common waste gas management and treatment systems in the chemical sector 27 for emissions to air of new installations (or for existing installations within 4 years of the BATC publication) where relevant conditions apply;

    (b)the Best Available Techniques Reference Document (BREF) for Manufacture of Organic Fine Chemicals (OFC) 28 ; for the manufacturing activity under conditions not covered by the BATC mentioned above;

    (c)the best available techniques (BAT) conclusions for common waste water and waste gas treatment/management systems in the chemical sector 29 ;

    (d)the Best Available Techniques Reference Document (BREF) for the Large Volume Inorganic Chemicals – Solids and Others industry 30 ;

    (e)the Best Available Techniques Reference Document (BREF) for the manufacture of Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers 31 ;

    (f)the Best Available Techniques Reference Document (BREF) for the production of speciality inorganic chemicals (SIC) for the manufacturing activity under conditions not covered by the BATC mentioned above  32 .

    Plants within the BAT-AEL range(s) moving to the mid-point ambition do not trigger any significant cross-media impact.

    Installations that have been granted a derogation in accordance with the procedure set out in Article 15(4) of Directive 2010/75/EU are not considered as fulfilling the technical screening criteria for the period of the derogation.

    2.2. Where a continuous measurement methodology for a certain pollutant is available, the operator applies Continuous Emission Monitoring Systems (CEMS), Continuous Effluent Quality Monitoring Systems (CEQMS) and other measures ensuring the regular verification of non-deterioration of environment.

    2.3. The operator applies solvent waste segregation for solvent recovery from concentrated waste streams, where technically applicable.

    Solvents included in Table 1 of the European Medicines Agency ICH guideline Q3C (R8) on impurities as specified in the guideline for residual solvents 33 are avoided in medicinal products.

    The maximum solvents loss from total inputs does not exceed a 3% loss. Total volatile organic compound (VOC) recovery efficiency is at least 99%.

    The operator verifies that no fugitive VOC emission occurs beyond the criteria specified below as to the parts per million volumetric (ppmv) thresholds by carrying out Leak detection and repair (LDAR) campaigns, at least every 3 years. Investments for the use of high integrity equipment are recommended, provided that these are installed in existing plants for cases mentioned under BAT 23b of the best available techniques (BAT) conclusions for common waste gas management and treatment systems in the chemical sector, whereas the pressure threshold is brought to 200 bar. The minimal verification schedule may be reduced in cases where quantification of total VOC emissions from the plant is periodically qualified with tracer correlation (TC) or with optical absorption-based techniques, such as differential absorption light detection and ranging (DIAL) or solar occultation flux (SOX) or other measures of equivalent performance.

    Diffuse emissions of substances or mixtures classified as CMR1A or 1B from leaky equipment do not exceed a concentration of 100 ppmv 34 .

    The LDAR campaigns have the features described in BAT19 of the best available techniques (BAT) conclusions for common waste gas management and treatment systems in the chemical sector, which include detecting, repairing and maintaining leaks within 30 days of detection and a leak threshold is lower than or equal to 5000 ppmv for substances or mixtures other than those classified as CMR 1A or 1B, which are reviewed and updated for the continuous improvement of the installation. Solvent losses and recovery efficiency of VOC are monitored based on a solvent management plan using a mass balance for verification of compliance, in accordance with Chapter V of Directive 2010/75/EU.

    2.4. Sewage, refuse, and other waste (including solids, liquids, or gaseous by-products from manufacturing) are disposed of in a safe, timely, and sanitary manner. Containers or pipes for waste material are clearly identified. Analytical data demonstrating the conversion of these substances and their residues to non-hazardous waste materials are available at the facility and kept up to date.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the activity involves on-site generation of heat/cool or co-generation including power, the direct GHG emissions of the activity are lower than 270 gCO2e/kWh.

    For the refrigerant threshold, the Global Warming Potential does not exceed 150 in cooling of the substance.

    Where medicinal products are made from substances listed in Sections 3.10 to 3.16 of Annex II to Commission Delegated Regulation (EU) 2021/2139, the GHG emissions do not exceed the limits set out in their respective technical screening criteria for DNSH to climate change mitigation.

    The substitution does not lead to an increment of lifecycle GHG emissions. Lifecycle GHG emissions are calculated using Recommendation 2013/179/EU or, alternatively, using ISO 14067:2018 35 or ISO 14064-1:2018 36 . Quantified life-cycle GHG emissions are verified by an independent third party.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    1. Waste water treatment:

    The performance of wastewater treatment processes conducted by or on behalf of the manufacturing plant does not lead to any deterioration of water bodies and marine resources.

    When activities fall within their scope, they meet the requirements of Directives 91/271/EEC, 2008/105/EC, 2006/118/EC, 2010/75/EU, 2000/60/EC, (EU) 2020/2184, 76/160/EEC, 2008/56/EC and 2011/92/EU.

    The activity implements best practices specified in the Joint Research Centre Best Environmental Management Practice for the Public Administration Sector 37 .

    Where wastewater treatment is conducted by an urban wastewater treatment plant on behalf of the manufacturing plant, it is ensured that:

    (a)the load of pollutants released by the manufacturing plant has no negative effect in the treatment process of the urban waste water treatment plant;

    (b)the load and characteristics of pollutants do not pose any risk or harm to the health of the staff working in waste water treatment plants;

    (c)the urban waste water treatment plant is designed and equipped appropriately to abate the released polluting substances;

    (d)the overall load of the concerned pollutants discharged to the water body is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set for direct releases;

    (e)the usability of the sewage sludge for nutrient (re)cycling is not affected.

    For installations where additional pollutant limits or stricter conditions have been included in their environmental permit compared to the requirements of the legislation mentioned above, these stricter conditions apply.

    2. Soil and groundwater protection:

    Appropriate measures are in place to prevent emissions to soil and regular surveillance is conducted to avoid leaks, spills, incidents or accidents occurring during the use of equipment and during storage.

    3. Water Consumption:

    Operators assess the water footprint of the chemical production processes in line with ISO 14046:2014 38 and ensure that they do not contribute to water scarcity. Based on this assessment, operators provide a declaration that they do not contribute to water scarcity which is verified by an independent third party.

    4. The activity complies with the criteria set out in Appendix B to this Annex.

    (4) Transition to a circular economy

    The activity assesses the availability of and, where feasible, adopts techniques that support:

    (a)reuse and use of secondary raw materials and reused components in products manufactured;

    (b)design for high durability, recyclability, easy disassembly and adaptability of products manufactured;

    (c)waste management that prioritises recycling over disposal, in the manufacturing process;

    (d)information on product ingredients along the supply chain.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.Water supply, sewerage, waste management and remediation activities 

    2.1.Collection and transport of hazardous waste

    Description of the activity

    Separate collection and transport of hazardous waste 39 prior to treatment, material recovery or disposal, including the construction, operation and upgrade of facilities involved in the collection and transport of such waste, such as hazardous waste transfer stations, as a means for appropriate treatment.

    The economic activities in this category could be associated with several NACE codes, in particular E38.12 and F42.9 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to pollution prevention and control

    1. Hazardous waste is source segregated and collected separately from non-hazardous waste to prevent cross-contamination. Appropriate measures are taken to ensure that during separate collection and transport, hazardous waste is not mixed nor diluted either with other categories of hazardous waste or with other waste, substances or materials.

    2. Proper collection and handling prevent leakage of hazardous waste during collection, transport, storage and delivery to the treatment facility, which is permitted to treat hazardous waste, according to national legislation.

    3. Where a given waste classified as hazardous has also a transport status of dangerous goods under the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) 40 , the transport complies with the relevant requirements set by the ADR.

    4. The activity uses waste collection vehicles which conform to at least EURO V standards 41 .

    5. During collection and transport, hazardous waste is packaged and labelled in accordance with the international and Union standards in force.

    6. The operator collecting hazardous waste complies with record-keeping obligations including as regards quantity, nature, origin, destination, frequency of collection, mode of transport and treatment method set out by applicable Union and national legislation.

    7. For waste from electrical and electronic equipment (WEEE):

    (a)the main categories of WEEE set out in Annex III to Directive 2012/19/EU are collected separately;

    (b)collection and transport preserve the integrity of WEEE and prevent the leakage of hazardous substances such as ozone-depleting substances, fluorinated greenhouse gases or mercury contained in fluorescent lamps;

    (c)a management system is set up by the collection and logistics operator to manage environmental, health and safety risks.

    Compliance with normative requirements for collection and logistics set in CLC/EN 50625-1:2014 42 and CLC/TS 50625-4:2017 43 or with regulatory requirements that are equivalent to those set in CLC/EN 50625-1 and CLC/TS 50625-4 is a proof of compliance with the requirement that the collection and transport preserve the integrity of WEEE and batteries and prevents the leakage of hazardous substances.

    8. When the waste is stored, the activity complies with the requirements set out in BAT 4 of the best available techniques (BAT) conclusions for waste treatment 44 .

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (4) Transition to a circular economy

    Separately collected waste is not mixed in waste storage and transfer facilities with other waste or materials with different properties.

    Recyclable 45 waste is not disposed of, incinerated or co-incinerated.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.2.Treatment of hazardous waste

    Description of the activity

    Construction, repurposing, upgrade, and operation of dedicated facilities for the treatment of hazardous waste, including the incineration of non-recyclable hazardous waste 46 (operations D10), biological treatment of hazardous waste (operations D8) and physico-chemical treatment (operations D9) 47 .

    The activity does not include:

    (a)disposal operations (as set out in Annex I to the Directive 2008/98/EC) of hazardous waste such as landfilling or permanent storage.

    (b)incineration of recyclable hazardous waste and incineration of non-hazardous waste;

    (c)treatment and disposal of toxic live or dead animals and other contaminated waste;

    (d)treatment and disposal of radioactive nuclear waste.

    The economic activities in this category could be associated with several NACE codes, in particular E38.22 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to pollution prevention and control

    1. For all waste treatment processes, the activity complies with the following criteria:

    1.1. According to the type of activity, the activity complies with the requirements set out either in the best available techniques (BAT) conclusions for waste treatment 48  or the best available techniques (BAT) conclusions for waste incineration 49 .

    Facilities that have been granted a derogation in accordance with the procedure set out in Article 15(4) of Directive 2010/75/EU are not considered as compliant with the Technical Screening Criteria.

    1.2. During the pre-acceptance procedures, at least the following information is gathered:

    (a)expected date of arrival at the waste treatment plant;

    (b)contact details of the waste producer, the sector which the waste originates from and the nature of process producing the waste, including the variability of the process;

    (c)the estimated quantity expected to be delivered to the operator per delivery and per year;

    (d)description of the waste, including composition, hazardous properties of the waste, waste code and the suitable treatment route.

    1.3. During the acceptance procedures, the following elements are in place:

    (a)a reception facility equipped with a laboratory to analyse samples on site and documented analytical standard operating procedures, with the option to sub-contract analyses to accredited external contract laboratories; 

    (b)documented sampling procedure consistent with relevant standards, such as EN 14899:2005 50 ;

    (c)documented analysis of the relevant physico-chemical parameters for the treatment;

    (d)a dedicated quarantine waste storage area, as well as written procedures to manage non-accepted waste.

    The personnel dealing with the pre-acceptance and acceptance procedures is able, due to their profession or experience, to deal with all necessary questions relevant for the treatment of the wastes in the waste treatment facility. The procedures are intended to pre-accepting and accepting wastes at the waste treatment plant only if a suitable treatment route is available and the disposal or recovery route for the output of the treatment is determined.

    For ‘blending or mixing activities’ (as set out in Annex I, section 5.1(c) of Directive 2010/75/EU), the operator is not using dilution to lower the concentration of one or more hazardous substances present in the waste, with the aim for the resulting waste mix to be declassified and become ‘non-hazardous waste’ and thus be subsequently treated in facilities non-dedicated to the treatment of hazardous waste. Dilution is not used as a ‘substitute’ to the adequate treatment of the waste.

    2. For the physico-chemical treatment of solid or pasty waste, any treatment for the purpose of treating waste prior to final disposal, such as in hazardous waste landfills, is designed to fullfil the following requirements:

    (a)limit at 6% the Total Organic Carbon (TOC) maximum concentration in each single input waste to the landfill;

    (b)limit at 1 000 mg/kg dry matter Dissolved Organic Carbon (DOC) content of the output waste after a leaching test with L/S = 10 l/kg based on EU Standard EN 12457-2:2002 51 .

    3. For the physico-chemical treatment of waste with calorific value, measures are taken in order to avoid dilution and dispersion of hazardous substances, and to avoid any high loads released into the air due to inappropriate final treatment of waste with calorific value. Any treatment installation prior to final thermal treatments (incineration or co-incineration) is to be designed with the purpose of limiting the content of hazardous substances (and meet other related criteria) for each single input waste treated at the physico-chemical treatment installation, so that the acceptance levels at the entrance of the final thermal treatment installations are respected.

    4. For the treatment of aqueous liquid waste, the biological treatability of the waste water resulting from the treatment of the water-based liquid waste in a biological waste water treatment plant is judged based on the following criterion:

    Dissolved Organic Carbon DOC elimination of >70% in 7 days (>80% when adapted inoculum is used) in accordance with EN ISO 9888 52 (Zahn Wellens), or other commonly accepted, equivalent industry standards and methodologies used to assess bio-elimination and related performances.

    5. For the treatment of waste containing Persistent Organic Pollutants (POP), all waste containing POP substances listed in Annex IV to Regulation (EU) 2019/1021 are controlled and traced as hazardous waste in accordance with Article 17 of Directive 2008/98/EC. Specific requirements of Articles 7(4), 17, 18 and 19 of Directive 2008/98/EC apply. In case of transboundary movement, requirements of Chapter I of the Regulation (EC) No 1013/2006 of the European Parliament and of the Council 53 apply.

    The tracking system in place in the installations based on the best practices referred to above allows the monitoring of:

    (a)the effective separation of each part of a product or waste such as waste equipment, containing or contaminated with POP above the levels defined in Annex IV to Regulation (EU) 2019/1021;

    (b)the effective destruction or irreversible transformation of the POP waste in compliance with Articles 7(2) – 7(4) and Annex V to Regulation (EU) 2019/1021.

    6. For the treatment of mercury-containing waste 54 , all installations likely to treat waste consisting of, containing or contaminated with mercury or mercury compounds (as defined in Article 11 of the Minamata Convention), implementthe traceability system set out in Article 14 of Regulation (EU) 2017/852 or a similar traceability system. Based on this tracking system, the installations treating mercury-containing waste monitor the effective safe fate of mercury and mercury compounds in appropriate final destination.

    7. For the (non-combustion) treatment of healthcare waste, the installation implements the best practices set out in the WHO handbook on safe management of wastes from health-care activities 55 .

    A non-combustion healthcare waste installation has specific acceptance procedure, monitors and can prove that the following types of healthcare waste are not accepted for treatment:

    (a)cytotoxic waste;

    (b)pharmaceutical waste;

    (c)chemical waste;

    (d)radioactive waste.

    The technologies used are certified by an independent certification body.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    N/A

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    Relevant techniques are deployed for the protection of water and marine resources, as set out in the best available techniques (BAT) conclusions for waste treatment 56

    (4) Transition to a circular economy

    N/A

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    2.3.Remediation of legally non-conforming landfills and abandoned or illegal waste dumps

    Description of the activity

    Remediation of legally non-conforming landfills 57 and of abandoned or illegal waste dumps 58  that have been closed and are not taking in further waste other than possibly inert or biostabilised waste to be used as landfill cover material (as far as allowed in the environmental permit for the remediation project).

    The activity may include any of the following remediation strategies and sub-activities typically implemented as part of projects aimed at removing, controlling, containing or diminishing polluting emissions 59 from non-conforming landfills and abandoned or illegal dumpsites:

    (a)remediation through environmental isolation of non-conforming or illegal landfills or dumpsites at the present site, including:

    (i)physical isolation, concentration, structural stabilisation and protection of the non-conforming or illegal landfill or dumpsite, including application of hydraulic barriers, sealing, drainage and cover layers;

    (ii)installation, operation and maintenance of drainage and separate collection and treatment systems for leachates and run-off water prior to discharge;

    (iii)installation, operation and maintenance of landfill gas collection, abatement and control systems, including wells, piping and flaring systems;

    (iv)application of top soil and vegetation cover for renaturation purposes;

    (b)remediation through excavation and removal of non-conforming or illegal landfills or dumpsites with subsequent treatment, recovery or disposal of excavated waste, including:

    (i)selective excavation of the waste deposited on the site, loading and transport to existing permitted treatment, recovery or disposal facilities with separate management of non-hazardous and hazardous waste;

    (ii)sorting and recovery of materials and fuels from excavated non-hazardous waste, including the installation, operation and maintenance of dedicated facilities and equipment for the duration of the remediation project;

    (c)remediation through decontamination of soils, surface and groundwater at the place of pollution, including the following:

    (i)selective excavation, loading, transport, temporary storage, backfilling of soil, with separate management of non-contaminated and contaminated soils;

    (ii)treatment of contaminated soil or water, either in situ or ex situ, using in particular physical, chemical or biological methods, including the installation, operation and maintenance of dedicated facilities for the duration of the remediation project;

    (iii)application of hydraulic barriers, active and passive barriers intended to limit/prevent migration of pollutants.

    The activity also includes all of the following sub-activities that are required to prepare, plan, monitor and follow-up on the above remediation measures:

    (a)preparatory investigations, including data collection and surveying activities (in particular geological or hydrological), technical feasibility and environmental impact studies required to define the remediation project;

    (b)site preparation, including earth moving and levelling works, construction or reinforcement of perimeter walls or fences, primary access and internal roads, demolition of buildings or other structures on the landfill site;

    (c)monitoring and control of the remediation measures, including:

    (i)sampling of soil, water, sediment, biota or other materials;

    (ii)laboratory analysis of samples to identify the nature and concentration of pollutants;

    (iii)installation, operation and maintenance of monitoring facilities and equipment such as observation wells in and outside the perimeter of the landfill site;

    (d)implementation of other environmental protection and pollution prevention and control measures to comply with the conditions imposed in the environmental permit for the remediation project, including measures for safeguarding safety of operations on-site and health of workers, such as for fire control, flood protection, hazardous waste management.

    The activity does not include:

    (a)the permanent closure, rehabilitation and after care of existing or new landfills that comply with the Council Directive 1999/31/EC 60 , or for activities located in third countries having equivalent national legislation or otherwise aligned with recognized international industry standards 61 ;

    (b)landfill gas transformation for utilization as energy carrier or industry feedstock;

    (c)redevelopment of the remediated site for other economic use such as recreational, residential or commercial areas, installation of photovoltaic (PV) panels;

    (d)compensatory measures for pollution caused by the landfill or dumpsite such as the development and operation of alternative water supply systems for affected population living in the surrounding area.

    The economic activities in this category could be associated with several NACE codes, in particular E39, E38.2, E38.32 and F42.9 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to pollution prevention and control

    1. The activity complies with all of the following criteria:

    (a)the remediation activity is not undertaken by the operator 62 that caused the pollution or a producer of waste or a person acting on behalf of that operator or producer in order to comply with the Directive 2004/35/CE of the European Parliament and of the Council 63 or, for activities located in third countries, with an equivalent national legislation or international standards that apply the polluter-pays-principle to the remediation of environmental pollution caused by economic activities;

    (b)relevant contaminants are removed, controlled, contained or diminished using physical, chemical, biological or other methods to ensure that the landfill and the contaminated area (land, water body or other), taking into account its use at the time of the damage or approved future use of the area, no longer pose any significant risk of adversely affecting human health and the environment, as specified in national regulatory standards or, where such standards are not available, in an internal risk-assessment taking into account the characteristic and the extent of the impacted area (land, water body or other), the type, properties (persistence, mobility and toxicity) and concentration of the substances, preparations, organisms or micro-organisms, possible migration pathways and the probability of dispersion 64 .

    2. The activity is prepared and conducted in line with best industry practice and includes all of the following elements:

    (a)the non-conforming or illegal landfill or dumpsite to be remediated has been closed and is not taking in further waste other than possibly inert or biostabilized waste to be used as landfill cover material (as far as allowed in the environmental permit for the remediation project);

    (b)preparatory investigations including site-specific surveys and physical, chemical or microbiological data collection are carried out in line with best industry practice and best available techniques to establish:

    (i)the location, characteristics and extent of the landfill and the polluted area;

    (ii)the underlying geological and hydrological conditions;

    (iii)the likely quantity, composition and sources of the landfilled waste;

    (iv)soil and water pollution originating from it as well as the risks to human health and the environment.

    (c)the results of such remedial investigations are inputs for a feasibility study that defines the objectives, targets and scope for the remediation and evaluates alternative remedial options;

    (d)the remedial options are analysed in accordance with the requirements set out in Annex II to Directive 2004/35/CE and in Annexes I and III to Directive 1999/31/EC, or for activities located in third countries in equivalent national law or commonly accepted international standards 65 , and described in a feasibility study produced for the landfill remediation project that convincingly demonstrates how the selected remedial option is the overall best solution to meet the defined remediation objectives and targets;

    (e)the landfill remediation project, including accompanying monitoring and control plan, is approved by the competent authority and consulted on with local stakeholders in accordance with national legal requirements;

    (f)all materials and fuels recovered from landfilled waste meet relevant quality standards or user specifications for the intended recovery operations and do not represent a risk for the environment or human health;

    (g)any hazardous waste extracted or otherwise produced by the remediation activity is subject to appropriate collection, transport, treatment, recovery or disposal by an authorized operator, in accordance with national legal requirements;

    (h)soil and groundwater remediation methods based exclusively on reducing pollutant concentrations through dilution or watering down are not used;

    (i)a control and monitoring plan is implemented, including measures to control the impacts of the remediation activities and to verify the achievement of the remediation objectives and targets, for at least 10 years in case of excavation and removal of the landfill or dumpsite and for at least 30 years in case of environmental isolation of the landfill or dumpsite, unless a different duration sufficient to guarantee long-term risk control is defined in national legislation or by the competent regulatory authority for the specific remediation project.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    Where the landfill body contains significant amounts of biodegradable waste, a system for landfill gas capture and abatement and a monitoring plan for landfill gas leakage is in place in accordance with operational and technical requirements of Directive 1999/31/EC, or for activities located in third countries in accordance with equivalent national law or commonly accepted international industry standards 66 .

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    Remedial measures are protective of water and marine resources and apply best industry practices and technology 67 with the aim of:

    (a)reducing the generation of leachates from the landfill and avoiding outflow or infiltration of leachates into the surrounding soil and any potential hazard to groundwater and surface water;

    (b)separately collecting and appropriately treating run-off water and leachates before discharge;

    (c)tracking and analysing leachate generation rates and leachate concentration and composition in the after-care period through appropriate control and monitoring systems and processes;

    (d)separately collecting and appropriately treating polluted soil in and around the landfill in order to block the pathway from the landfill to waterbodies through heavily soaked soil.

    (4) Transition to a circular economy

    Where the remediation project foresees the excavation and removal of the existing landfill or dumpsite, the excavated waste is managed in accordance with the waste hierarchy principle, prioritizing recycling over other types of material recovery, over incineration and disposal, to the extent that this is technically feasible and does not increase risks for the environmental or human health.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    Where applicable, the introduction of invasive alien species is prevented or their spread is managed in accordance with Regulation (EU) No 1143/2014.

    2.4.Remediation of contaminated sites and areas

    Description of the activity

    The activity includes:

    (a)decontamination or remediation of soils and groundwater in the polluted area, either in situ or ex situ, in particular using physical, chemical or biological methods;

    (b)decontamination or remediation of contaminated industrial plants or sites;

    (c)decontamination or remediation of surface water and its shores following accidental pollution, such as through collection of pollutants or through physical, chemical or biological methods;

    (d)cleaning up oil spills and other types of pollutants on or in:

    (i)surface water including rivers, lakes, coastal waters or transitional waters;

    (ii)groundwater as defined in Directive 2000/60/EC;

    (iii)marine water as defined in Directive 2008/56/EC;

    (iv)sediments (for all surface water types);

    (v)aquatic ecosystems;

    (vi)buildings;

    (vii)soil;

    (viii)terrestrial ecosystems ;

    (e)material abatement of hazardous substances, mixtures or products, such as asbestos or lead-based paint;

    (f)other specialised pollution-control activities;

    (g)clean-up after disasters from natural hazards, such as flooding, or earthquake;

    (h)remediation of disused mining sites or legacies not associated with extraction revenues;

    (i)containment operations, hydraulic barriers, active and passive barriers intended to limit or prevent migration of pollutants.

    The activity also includes all activities that are required to prepare, plan, monitor and follow-up the decontamination or remediation activity itself, such as:

    (a)preparatory investigations, including data collection and surveying activities (in particular geological or hydrological), technical feasibility and environmental impact studies required to define the remediation project;

    (b)monitoring and control of the remediation measures, including:

    (i)sampling of soil, water, sediment, biota or other materials;

    (ii)laboratory analysis of samples to identify the nature and concentration of pollutants;

    (iii)installation, operation and maintenance of monitoring facilities and equipment such as observation wells in and outside the perimeter of the remediation site;

    (c)demolition of contaminated buildings or other structures, dismantling large-scale machinery and equipment (i.e., decommissioning) and removal of surface sealing and concreting;

    (d)earth moving or dredging, including excavation, landfilling, levelling, construction or reinforcement of perimeter walls or fences, primary access and internal roads and any other activities necessary to operate the decontamination;

    (e)implementation of other environmental protection and pollution prevention and control measures to comply with the conditions imposed in the environmental permit for the remediation project, including measures for safeguarding safety of operations on-site and health of workers (such as for fire control, flood protection, hazardous waste management), protection of workers, site access control, management of invasive species before or during decontamination or remediation, reinforcement operations carried out prior to or during decontamination.

    This economic activity does not include:

    (a)pest control in agriculture;

    (b)purification of water for water supply purposes;

    (c)decontamination or remediation of nuclear plants and sites;

    (d)treatment and disposal of hazardous or non-hazardous waste unrelated to the site contamination problem;

    (e)morphological remediation;

    (f)remediation of legally non-conforming landfills and abandoned or illegal waste dumps unrelated to the site under remediation (See Section 2.3. of this Annex);

    (g)emergency services (see Section 14.1. of Annex II to Delegated Regulation (EU) 2021/2139);

    (h)outdoor sweeping and watering of streets.

    The economic activities in this category could be associated with several NACE codes, in particular 39, 33.20, 43.11, 43.12, 71.12, 71.20, 74.90, 81.30 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.

    Technical screening criteria

    Substantial contribution to pollution prevention and control

    1. Remediation activities are not carried out by the operator 68 that caused the pollution or a person acting on behalf of that operator in order to comply with the requirements of Directive 2004/35/CE or, for activities located in third countries, with environmental liability provisions based on the ‘polluter-pays’ principle according to national law.

    2. The relevant contaminants are removed, controlled, contained or diminished using mechanical, chemical, biological or other methods so that the contaminated area (land, water body or other), taking into account its use at the time of the damage or approved future use of the area, no longer poses any significant risk of adversely affecting human health and the environment 69 , as set out in one of the following:

    (a)national regulatory standards;

    (b)where these standards are not available, an internal site-specific risk-assessment taking into account the characteristic and the extent of the impacted area (land, water body or other), the type, properties (persistence, mobility and toxicity) and concentration of the substances, preparations, organisms or micro- organisms, possible migration pathways and the probability of dispersion 70 .

    3. The remediation activity is conducted in line with best industry practice and includes all of the following elements:

    (a)the original operational activity or defective plant and ancillary equipment that led to the contamination has been stopped or addressed so as not to be a potential source of further contamination before any assessment or remediation activity is undertaken (except long-range transboundary air pollution or other unidentifiable diffuse sources);

    (b)preparatory investigations including site-specific surveys and physical, chemical or microbiological data collection are carried out in line with best industry practice and best available techniques to establish the following elements used to define the environmental targets for the remediation and evaluate the remedial options:

    (i)the location, characteristics and extent of the contaminated site;

    (ii)the underlying geological and hydrological conditions;

    (iii)the likely quantity, composition and sources of contamination;

    (iv)soil and water pollution originating from it as well as the risks to human health and the environment.

    (c)the remedial options are analysed in line with Annex II to Directive 2004/35/CE 71 and the most suitable remedial measures are defined in a dedicated remediation plan, including monitoring requirements and plan;

    (d)any hazardous or non-hazardous waste or contaminated soils extracted or otherwise produced by the remediation activity is subject to appropriate collection, transport, treatment, recovery or disposal by an authorized operator, in accordance with legal requirements and care is taken to prevent any mixing of excavated contaminated soils and non-contaminated soils;

    (e)remediation methods do not include reducing pollutant concentrations through dilution or watering down, unless a full justification, for reason other than cost considerations, is provided in the remediation plan;

    (f)control, monitoring or maintenance activities are carried out in the after-care phase of at least 10 years, unless a different duration sufficient to guarantee long-term risk control is defined in the national law or in the remediation and monitoring plan (see point 4).

    4. The specific remediation and monitoring plan is approved by the competent authority in accordance with national legal requirements, following consultation with local stakeholders.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    The activity does not involve the degradation of land with high carbon stock 72 .

    Measures to reduce scope 1 and scope 2 GHG emissions 73 of the full removal or treatment process are included in the remediation plan.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (4) Transition to a circular economy

    At least 70% (by weight) of the non-hazardous construction, demolition or other waste materials (excluding naturally occurring material defined in category 17 05 04 in the European List of Waste established by Decision 2000/532/EC) generated on the site under remediation is prepared for reuse, recycling and other material recovery, including backfilling operations using waste to substitute other materials, in accordance with the waste hierarchy and the EU Construction and Demolition Waste Management Protocol 74 , unless a clear justification is given in the approved Remediation Plan based on technical or environmental reasons, other than cost considerations.

    (6) Protection and restoration of biodiversity and ecosystems

    The activity complies with the criteria set out in Appendix D to this Annex.

    The following is to be ensured:

    (a)    in the Union, in relation with Natura 2000 sites: the activity does not have significant effects on Natura 2000 sites in view of their conservation objectives on the basis of an appropriate assessment carried out in accordance with Article 6(3) of Directive 92/43/EEC;

    (b)    in the Union, in any area: the activity is not detrimental to the recovery or maintenance of the populations of species protected under Directives 92/43/EEC and 2009/147/EC at a favourable conservation status. The activity is also not detrimental to the recovery or maintenance of the habitat types concerned and protected under Directive 92/43/EEC at a favourable conservation status;

    (c)    the introduction of invasive alien species is prevented, or their spread is managed in accordance with Regulation (EU) No 1143/2014.



    Appendix A: Generic criteria for DNSH to climate change adaptation

    I. Criteria

    The physical climate risks that are material to the activity have been identified from those listed in the table in Section II of this Appendix by performing a robust climate risk and vulnerability assessment with the following steps:

    (a)    screening of the activity to identify which physical climate risks from the list in Section II of this Appendix may affect the performance of the economic activity during its expected lifetime;

    (b)    where the activity is assessed to be at risk from one or more of the physical climate risks listed in Section II of this Appendix, a climate risk and vulnerability assessment to assess the materiality of the physical climate risks on the economic activity;

    (c)    an assessment of adaptation solutions that can reduce the identified physical climate risk.

    The climate risk and vulnerability assessment is proportionate to the scale of the activity and its expected lifespan, such that:

    (a)    for activities with an expected lifespan of less than 10 years, the assessment is performed, at least by using climate projections at the smallest appropriate scale;

    (b)    for all other activities, the assessment is performed using the highest available resolution, state-of-the-art climate projections across the existing range of future scenarios 75 consistent with the expected lifetime of the activity, including, at least, 10 to 30 year climate projections scenarios for major investments.

    The climate projections and assessment of impacts are based on best practice and available guidance and take into account the state-of-the-art science for vulnerability and risk analysis and related methodologies in line with the most recent Intergovernmental Panel on Climate Change reports 76 , scientific peer-reviewed publications, and open source 77 or paying models.

    For existing activities and new activities using existing physical assets, the economic operator implements physical and non-physical solutions (‘adaptation solutions’), over a period of time of up to five years, that reduce the most important identified physical climate risks that are material to that activity. An adaptation plan for the implementation of those solutions is drawn up accordingly.

    For new activities and existing activities using newly-built physical assets, the economic operator integrates the adaptation solutions that reduce the most important identified physical climate risks that are material to that activity at the time of design and construction and has implemented them before the start of operations.

    The adaptation solutions implemented do not adversely affect the adaptation efforts or the level of resilience to physical climate risks of other people, of nature, of cultural heritage, of assets and of other economic activities; are consistent with local, sectoral, regional or national adaptation strategies and plans; and consider the use of nature-based solutions 78 or rely on blue or green infrastructure 79 to the extent possible.

    II. Classification of climate-related hazards 80

    Temperature-related

    Wind-related

    Water-related

    Solid mass-related

    Chronic

    Changing temperature (air, freshwater, marine water)

    Changing wind patterns

    Changing precipitation patterns and types (rain, hail, snow/ice)

    Coastal erosion

    Heat stress

    Precipitation or hydrological variability

    Soil degradation

    Temperature variability

    Ocean acidification

    Soil erosion

    Permafrost thawing

    Saline intrusion

    Solifluction

    Sea level rise

    Water stress

    Acute

    Heat wave

    Cyclone, hurricane, typhoon

    Drought

    Avalanche

    Cold wave/frost

    Storm (including blizzards, dust and sandstorms)

    Heavy precipitation (rain, hail, snow/ice)

    Landslide

    Wildfire

    Tornado

    Flood (coastal, fluvial, pluvial, ground water)

    Subsidence

    Glacial lake outburst



    Appendix B: Generic criteria for DNSH to sustainable use and protection of water and marine resources

    Environmental degradation risks related to preserving water quality and avoiding water stress are identified and addressed with the aim of achieving good water status and good ecological potential as defined in Article 2, points (22) and (23), of Regulation (EU) 2020/852, in accordance with Directive 2000/60/EC 81 and a water use and protection management plan, developed thereunder for the potentially affected water body or bodies, in consultation with relevant stakeholders.

    Where an Environmental Impact Assessment is carried out in accordance with Directive 2011/92/EU and includes an assessment of the impact on water in accordance with Directive 2000/60/EC, no additional assessment of impact on water is required, provided the risks identified have been addressed.

    The activity does not hamper the achievement of good environmental status of marine waters or does not deteriorate marine waters that are already in good environmental status as defined in point 5 of Article 3 of Directive 2008/56/EC 82 , taking into account the Commission Decision (EU) 2017/848 in relation to the relevant criteria and methodological standards for those descriptors.



    Appendix D: Generic criteria for DNSH to protection and restoration of biodiversity and ecosystems

    An Environmental Impact Assessment (EIA) or screening 83 has been completed in accordance with Directive 2011/92/EU 84 .

    Where an EIA has been carried out, the required mitigation and compensation measures for protecting the environment are implemented.

    For sites/operations located in or near biodiversity-sensitive areas (including the Natura 2000 network of protected areas, UNESCO World Heritage sites and Key Biodiversity Areas, as well as other protected areas), an appropriate assessment 85 , where applicable, has been conducted and based on its conclusions the necessary mitigation measures 86 are implemented.

    (1)    European Medicines Agency Guidelines on the environmental risk assessment of medicinal products for human use, version of [adoption date] available at https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use-scientific-guideline.
    (2)    Key metabolites are human metabolites likely to be excreted into the environment. Those metabolites are identified in (non-)clinical studies on the metabolism of medicinal products available in the marketing authorization applications. Such metabolites are to be identified according to EMA/CPMP/ICH/286/1995, page 8. Key transformation products (TP) of these key human metabolites of the parent compound (API) are those that exceed 10% of Dissolved Organic Carbon (DOC) or Total Organic Carbon (TOC) of the parent compound.
    (3)    OECD Guidelines for the Testing of Chemicals, Test 301 (A-F), Ready Biodegradability, version of [adoption date] available at https://www.oecd.org/chemicalsafety/risk-assessment/1948209.pdf. OECD 301 (A-F) test is used to identify substances which are assumed to rapidly and ultimately biodegrade, i.e., mineralised under aerobic environmental conditions).
    (4)    Higher-tier studies (OECD 308) result with so-called half-lives indicating the time after which 50 % biodegradation of the API is achieved. Half-lives acceptable to demonstrate sufficiently quick biodegradation, i.e., non-persistence, according to the Regulation (EC) No 1907/2006, Annex XIII, which is also referenced in the EMA ERA guideline, apply.
    (5)    OECD Guidelines for the Testing of Chemicals, Test No. 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems, version of [adoption date] available at: https://www.oecd-ilibrary.org/environment/test-no-308-aerobic-and-anaerobic-transformation-in-aquatic-sediment-systems_9789264070523-en.
    (6)    The Commission will review the exceptions from the prohibition from manufacturing, placing on the market or use of the substances referred to in points (f) and (g) once it will have published horizontal principles on essential use of chemicals.
    (7)    The requirements under this point tackle the pollutants identified under the key environmental issues of each BREF document or the BAT-AEL of the relevant BAT conclusions Commission Implementing Decisions. Where BAT-AEL differentiate between “existing” and “new plants”, operators demonstrate compliance with BAT-AEL for new plants. When there is not a BAT-AEL range but a single value, emission levels are below such value. When the BAT-AEL range is expressed as follows: “<x-y unit” (i.e the lower-end BAT-AEL of the range is expressed as ‘lower than’), the mid-point is calculated using x and y. Averaging periods are the same as in the BAT-AEL of the BREF documents outlined above.
    (8)    Commission Implementing Decision (EU) 2022/2427 of 6 December 2022 establishing the best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions, for common waste gas management and treatment systems in the chemical sector (OJ L 318, 12.12.2022, p. 157).
    (9)    The Best Available Techniques Reference Document (BREF) for Manufacture of Organic Fine Chemicals, available at https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/ofc_bref_0806.pdf.
    (10)    Commission Implementing Decision (EU) 2016/902 of 30 May 2016 establishing best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council, for common waste water and waste gas treatment/management systems in the chemical sector  (OJ L 152, 9.6.2016, p. 23).
    (11)    Best Available Techniques (BAT) Reference Document for the Large Volumes Inorganic Chemicals- Solids and Others industry, (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic-s_bref_0907.pdf).
    (12)    Best Available Techniques (BAT) Reference Document for the manufacture of Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic_aaf.pdf ).  
    (13)    The Best Available Techniques Reference Document (BREF) for the production of speciality inorganic chemicals (SIC), (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/reference/production-speciality-inorganic-chemicals).
    (14)    European Medicines Agency ICH guideline Q3C (R8) on impurities: guideline for residual solvents. Step 5, 2022, version of [adoption date] available at . https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf.
    (15)    Where the exemption under criterion 1.3 applies.
    (16)    ISO standard 14067:2018, Greenhouse gases — Carbon footprint of products — Requirements and guidelines for quantification, version of [adoption date] available at: https://www.iso.org/standard/71206.html.
    (17)    ISO standard 14064-1:2018, Greenhouse gases — Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals, version of [adoption date] available at: https://www.iso.org/standard/66453.html.
    (18)    Joint Research Centre, Best Environmental Management Practice for the Public Administration Sector, 2019, version of [adoption date] available at https://op.europa.eu/en/publication-detail/-/publication/6063f857-7789-11e9-9f05-01aa75ed71a1/language-en.
    (19)    ISO 14046:2014 Environmental management — Water footprint — Principles, requirements and guidelines, version of [adoption date] available at: https://www.iso.org/standard/43263.html.
    (20)    European Medicines Agency Guidelines on the environmental risk assessment of medicinal products for human use, version of [adoption date] available at https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use-scientific-guideline.
    (21)    Key metabolites are human metabolites likely to be excreted into the environment. Those metabolites are identified in (non-)clinical studies on the metabolism of medicinal products available in the marketing authorization applications. Such metabolites are to be identified according to EMA/CPMP/ICH/286/1995, page 8. Key transformation products (TP) of these key human metabolites of the parent compound (API) are those that exceed 10% of Dissolved Organic Carbon (DOC) or Total Organic Carbon (TOC) of the parent compound.
    (22)    OECD Guidelines for the Testing of Chemicals, Test 301 (A-F), Ready Biodegradability, version of [adoption date] available at https://www.oecd.org/chemicalsafety/risk-assessment/1948209.pdf. OECD 301 (A-F) test is used to identify substances which are assumed to rapidly and ultimately biodegrade, i.e., mineralised under aerobic environmental conditions).
    (23)    Higher-tier studies (OECD 308) result with so-called half-lives indicating the time after which 50 % biodegradation of the API is achieved. Half-lives acceptable to demonstrate sufficiently quick biodegradation, i.e., non-persistence, according to the Regulation (EC) No 1907/2006, Annex XIII, which is also referenced in the EMA ERA guideline, apply.
    (24)    OECD Guidelines for the Testing of Chemicals, Test No. 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems, version of [adoption date] available at: https://www.oecd-ilibrary.org/environment/test-no-308-aerobic-and-anaerobic-transformation-in-aquatic-sediment-systems_9789264070523-en.
    (25)    The Commission will review the exceptions from the prohibition from manufacturing, placing on the market or use of the substances referred to in points (f) and (g) once it will have published horizontal principles on essential use of chemicals.
    (26)    The requirements under this point tackle the pollutants identified under the key environmental issues of each BREF document or the BAT-AEL of the relevant BAT conclusions Commission Implementing Decisions. Where BAT-AEL differentiate between “existing” and “new plants”, operators demonstrate compliance with BAT-AEL for new plants. When there is not a BAT-AEL range but a single value, emission levels are below such value. When the BAT-AEL range is expressed as follows: “<x-y unit” (I.e the lower-end BAT-AEL of the range is expressed as ‘lower than’), the mid-point is calculated using x and y. Averaging periods are the same as in the BAT-AEL of the BREF documents outlined above.
    (27)    Implementing Decision (EU) 2022/2427.
    (28)    The Best Available Techniques Reference Document (BREF) for Manufacture of Organic Fine Chemicals, (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/ofc_bref_0806.pdf).
    (29)    Implementing Decision (EU) 2016/902.
    (30)    Best Available Techniques (BAT) Reference Document for the Large Volumes Inorganic Chemicals- Solids and Others industry, (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic-s_bref_0907.pdf).
    (31)    Best Available Techniques (BAT) Reference Document for the manufacture of Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers (version of [adoption date]: https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic_aaf.pdf ).  
    (32)    The Best Available Techniques Reference Document (BREF) for the production of speciality inorganic chemicals (SIC) (version of [adoption date]:https://eippcb.jrc.ec.europa.eu/reference/production-speciality-inorganic-chemicals).
    (33)    European Medicines Agency ICH guideline Q3C (R8) on impurities: guideline for residual solvents. Step 5, 2022, version of [adoption date] available at . https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf.
    (34)    Where the exemption under criterion 1.3 applies.
    (35)    ISO standard 14067:2018, Greenhouse gases — Carbon footprint of products — Requirements and guidelines for quantification, version of [adoption date] available at: https://www.iso.org/standard/71206.html.
    (36)    ISO standard 14064-1:2018, Greenhouse gases — Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals, version of [adoption date] available at: https://www.iso.org/standard/66453.html.
    (37)    Joint Research Centre, Best Environmental Management Practice for the Public Administration Sector, 2019, version of [adoption date] available at https://op.europa.eu/en/publication-detail/-/publication/6063f857-7789-11e9-9f05-01aa75ed71a1/language-en.
    (38)    ISO 14046:2014 Environmental management — Water footprint — Principles, requirements and guidelines, version of [adoption date] available at: https://www.iso.org/standard/43263.html.
    (39)    Hazardous waste is waste which displays one or more of the hazardous properties listed in Annex III of Directive 2008/98/EC. It includes streams such as hazardous waste fractions produced by households, waste oils, batteries, non-depolluted waste from electrical and electronic equipment (WEEE), non-depolluted end-of-life vehicle, certain healthcare waste, such as infectious and cytotoxic waste, etc. A comprehensive classification of hazardous waste can be found in the European List of Waste (established by Commission Decision 2000/532/EC).
    (40)    Version of [adoption date], available at https://unece.org/transport/standards/transport/dangerous-goods/adr-2023-agreement-concerning-international-carriage.
    (41)    In accordance with Regulation (EU) 2018/858.
    (42)    CLC/EN 50625-1: 2014 Collection, logistics & Treatment requirements for WEEE - Part 1: General treatment requirements.
    (43)    Collection, logistics & treatment requirements for WEEE -- Part 4: Specification for the collection and logistics associated with WEEE.
    (44)    Implementing Decision (EU) 2018/1147.
    (45)    ‘Recyclable waste’ is waste that can be recycled in accordance with Article 3(17) of Directive 2008/98/EC.
    (46)    ‘Non-recyclable waste’ is waste that cannot be recycled in accordance with Article 3(17) of Directive 2008/98/EC.
    (47)    As set out in Annex I to Directive 2008/98/EC.
    (48)    Implementing Decision (EU) 2018/1147.
    (49)    Commission Implementing Decision (EU) 2019/2010 of 12 November 2019 establishing the best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council, for waste incineration (OJ L 312, 3.12.2019, p. 55).
    (50)    EN 14899:2005 Characterization of waste - Sampling of waste materials - Framework for the preparation and application of a Sampling Plan.
    (51)    EN 12457-2:2002 Characterisation of waste - Leaching - Compliance test for leaching of granular waste materials and sludges - Part 2: One stage batch test at a liquid to solid ratio of 10 l/kg for materials with particle size below 4 mm (without or with size reduction).
    (52)    EN ISO 9888:1999 Water quality — Evaluation of ultimate aerobic biodegradability of organic compounds in aqueous medium — Static test (Zahn-Wellens method), version of [adoption date] available at: https://www.iso.org/standard/28121.html.
    (53)    Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste (OJ L 190, 12.7.2006, p. 1).
    (54)    Mercury-containing waste means waste consisting of, containing or contaminated with mercury or mercury compounds.
    (55)    WHO, Safe management of wastes from health-care activities, 2nd edition, 2014, version of [adoption date] available at https://www.euro.who.int/__data/assets/pdf_file/0012/268779/Safe-management-of-wastes-from-health-care-activities-Eng.pdf.
    (56)    Implementing Decision (EU) 2018/1147.
    (57)    The term ‘landfill’ is defined in Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999, p. 1) as a “waste disposal site for the deposit of the waste onto or into land (i.e., underground)” including both non-hazardous and hazardous waste.A ‘legally non-conforming’ landfill is a landfill that does not comply with the operational and technical requirements defined in relevant EU or national legislation.
    (58)    A ‘waste dump’ is a site used for the disposal of waste that is not equipped with pollution abatement systems.
    (59)    Emission’ means the release in the environment, as a result of human activities, of substances, preparations, organisms or micro-organisms (as set out in Article 2 of Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (OJ L 143, 30.4.2004, p. 56).
    (60)    Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste, OJ L 182, 16.7.1999, p. 1.
    (61)    Such as, at the international level, landfill operational guidelines published by the International Solid Waste Association (ISWA).
    (62)    As defined in Article 2, point 6, of Directive 2004/35/CE.
    (63)    Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (OJ L 143, 30.04.2004, p. 56).
    (64)    See Directive 2004/35/CE , Annex II, point 2. For remediation activities outside the EU, unless equal or more stringent standards are mandatory under national legislation, reference is made to the UNEP Guidance on the management of contaminated sites.
    (65)    See Directive 2004/35/CE, Annex II, point 1.3.1. For remediation activities outside the EU, reference is made to the UNEP Guidance on the management of contaminated sites and the standards and guidance documents for landfill management published by the International Solid Waste Association, including International Guidelines for Landfill Evaluation (2011), Roadmap for Closing Waste Dumpsites (2016) and Landfill Operational Guidelines (2014, 2019).
    (66)    For remediation activities outside the EU, reference is made to the UNEP Guidance on the management of contaminated sites and the standards and guidance documents for landfill management published by the International Solid Waste Association, including International Guidelines for Landfill Evaluation (2011), Roadmap for Closing Waste Dumpsites (2016) and Landfill Operational Guidelines (2014, 2019).
    (67)    For remediation activities outside the EU, reference is made to the UNEP Guidance on the management of contaminated sites and the standards and guidance documents for landfill managament published by the International Solid Waste Association, including International Guidelines for Landfill Evaluation (2011), Roadmap for Closing Waste Dumpsites (2016) and Landfill Operational Guidelines (2014, 2019).
    (68)    As defined in Article 2, point 6, of, Directive 2004/35/CE.
    (69)    See Directive 2004/35/CE , Annex II, point 2.
    (70)    See Directive 2004/35/CE , Annex II, point 2. For activities in third countries, unless more stringent standards are mandatory under national legislation, UNEP Guidance on the management of contaminated sites (UNEP/MC/COP.3/8/Rev.1) - Guidance_Contaminated_Sites_EN.pdf (mercuryconvention.org) are applied.
    (71)    See Directive 2004/35/CE, Annex II, point 1.3.1.For activities in third countries, in accordance with equivalent applicable national law or international standards (such as UNEP Guidance on the management of contaminated sites (UNEP/MC/COP.3/8/Rev.1) -Guidance_Contaminated_Sites_EN.pdf (mercuryconvention.org) ) requiring remediation based on an alternative, transparently described process and valuation approach to define a suitable strategy, which comprises primary remedial measures (including monitoring requirements), complementary and compensatory remedial measures in a dedicated remediation plan.
    (72)    Land with high-carbon stock means wetlands, including peatland, and continuously forested areas grasslands, mangroves and seagrass meadows within the meaning of Article 29(4)(a), (b) and (c) of Directive (EU) 2018/2001.
    (73)    ‘Scope 1 GHG emissions’ means the direct greenhouse gas emissions occurring from sources that are owned or controlled by the operator. ‘Scope 2 GHG emissions’ means the indirect greenhouse gas emissions from the generation of the electricity consumed by the operator.
    (74)    EU Construction & Demolition Waste Management Protocol, September 2016: https://ec.europa.eu/docsroom/documents/20509/.
    (75)    Future scenarios include Intergovernmental Panel on Climate Change representative concentration pathways RCP2.6, RCP4.5, RCP6.0 and RCP8.5.
    (76)    Assessments Reports on Climate Change: Impacts, Adaptation and Vulnerability, published periodically by the Intergovernmental Panel on Climate Change (IPCC), the United Nations body for assessing the science related to climate change produces, https://www.ipcc.ch/reports/.
    (77)    Such as Copernicus services managed by the European Commission.
    (78)    Nature-based solutions are defined as ‘solutions that are inspired and supported by nature, which are cost-effective, simultaneously provide environmental, social and economic benefits and help build resilience. Such solutions bring more, and more diverse, nature and natural features and processes into cities, landscapes and seascapes, through locally adapted, resource-efficient and systemic interventions’. Therefore, nature-based solutions benefit biodiversity and support the delivery of a range of ecosystem services.(version of [adoption date]: https://ec.europa.eu/research/environment/index.cfm?pg=nbs ).
    (79)    See Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Green Infrastructure (GI) — Enhancing Europe’s Natural Capital (COM/2013/0249 final).
    (80)    The list of climate-related hazards in this table is non-exhaustive, and constitutes only an indicative list of most widespread hazards that are to be taken into account as a minimum in the climate risk and vulnerability assessment.
    (81)    For activities in third countries, in accordance with applicable national law or international standards which pursue equivalent objectives of good water status and good ecological potential, through equivalent procedural and substantive rules, i.e. a water use and protection management plan developed in consultation with relevant stakeholders which ensures that 1) the impact of the activities on the identified status or ecological potential of potentially affected water body or bodies is assessed and 2) deterioration or prevention of good status/ecological potential is avoided or, where this is not possible, 3) justified by the lack of better environmental alternatives which are not disproportionately costly/technically unfeasible, and all practicable steps are taken to mitigate the adverse impact on the status of the body of water.
    (82)    The definition laid down in point 5 of Article 3 of Directive 2008/56/EC provides in particular that good environmental status is to be determined on the basis of the qualitative descriptors laid down in Annex I to that Directive.
    (83)    The procedure through which the competent authority determines whether projects listed in Annex II to Directive 2011/92/EU is to be made subject to an environmental impact assessment (as referred to in Article 4(2) of that Directive).
    (84)    For activities in third countries, in accordance with equivalent applicable national law or international standards requiring the completion of an EIA or screening, for example, IFC Performance Standard 1: Assessment and Management of Environmental and Social Risks.
    (85)    In accordance with Directives 2009/147/EC and 92/43/EEC. For activities located in third countries, in accordance with equivalent applicable national law or international standards, that aim at the conservation of natural habitats, wild fauna and wild flora, and that require to carry out (1) a screening procedure to determine whether, for a given activity, an appropriate assessment of the possible impacts on protected habitats and species is needed; (2) such an appropriate assessment where the screening determines that it is needed, for example IFC Performance Standard 6: Biodiversity Conservation and Sustainable Management of Living Natural Resources.
    (86)    Those measures have been identified to ensure that the project, plan or activity will not have any significant effects on the conservation objectives of the protected area.
    Top

    TABLE OF CONTENTS

    ANNEX IV    2

    1.Environmental protection and restoration activities2

    1.1.Conservation, including restoration, of habitats, ecosystems and species2

    2.Accommodation activities7

    2.1.Hotels, holiday, camping grounds and similar accommodation7

    ANNEX IV

    Technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the protection and restoration of biodiversity and ecosystems and for determining whether that economic activity causes no significant harm to any of the other environmental objectives

    1.Environmental protection and restoration activities

    1.1.Conservation, including restoration, of habitats 1 , ecosystems 2 and species

    Description of the activity

    Initiation, development and realisation on own account or on a fee or contract basis, of conservation activities, including restoration activities, aimed at maintaining or improving the status and trends of terrestrial, freshwater and marine habitats, ecosystems and populations of related fauna and flora species.

    The economic activity includes:

    (a)activities of in-situ conservation, defined by the Convention on Biological Diversity (CBD) 3 as the conservation of ecosystems and natural habitats and the maintenance and recovery of viable populations of species in their natural surroundings;

    (b)activities of restoration defined as activities actively or passively assisting the recovery i) of an ecosystem towards or to good condition 4 , ii) of a habitat type to the highest level of condition attainable and to its favourable reference area or natural extent, iii) of a habitat of a species 5 to a sufficient quality and quantity, or iv) of species populations to satisfactory levels.

    The economic activity does not include ex-situ conservation of components of biological diversity, including in botanical gardens, zoos, aquaria or seed banks.

    The economic activities in this category have no dedicated NACE code but are partially covered under NACE code R91.04 as referred to in the statistical classification of economic activities established by Regulation (EC) No 1893/2006. The activities relate to Class 6 of the statistical classification of environmental protection activities (CEPA) established by Regulation (EU) No 691/2011 of the European Parliament and of the Council 6 .

    Technical screening criteria

    Substantial contribution to protection and restoration of biodiversity and ecosystems

    1. General conditions

    1.1. The activity contributes to at least one of the following:

    (a)maintaining good condition of ecosystems, species, habitats or of habitats of species;

    (b)re-establishing or restoring ecosystems, habitats or habitats of species towards or to good condition, including through increasing their area or range. 

    1.2. The activity may be carried out by any type of operator irrespective of the main domain of activity.

    2.    Initial description of the area covered by the conservation activity

    2.1. The activity takes place in an area with a detailed description of its initial ecological conditions which contains the following elements:

    (a)mapping of the current habitats and their condition;

    (b)where applicable, the protection status of the area;

    (c)characterisation of the situation of the main species in terms of conservation relevance present in the area (including list of species, approximate size of the population, approximate size of the habitat of the species and its quality, period during which the area is used by the species);

    (d)the importance of the area to reaching good condition of species, habitats or habitats of species at regional, national or international level as appropriate;

    (e)where relevant, the potential for improving the condition of species, habitats or habitats of species present on the area or re-establishing habitats or habitats of species in the area or to enhance connectivity between habitats.

    3.Management plan or equivalent instrument

    3.1. The area is covered by a management plan or by an equivalent instrument, such as a restoration plan 7 , which is regularly updated and in any case at least every ten years, and contains the following information:

    (a)a description of the expected contribution of the area to the nature conservation objectives set by the competent nature or environment authority considering the regional, national, Union and international legal and policy context;

    (b)the list of species, habitats and habitats of the species that will benefit from the conservation measures (hereafter “targeted habitats and species”);

    (c)the duration of the plan and a clear description of the conservation objectives for each targeted habitat and species and of the corresponding conservation measures that address identified pressures and threats, including the expected deadline for the achievement of the conservation objectives. In case the deadlines exceed the duration of the management plan, the expected progress (milestones) towards achievement is defined;

    (d)a description of the threats and pressures that could hinder the achievement of the conservation objectives, including projected habitat transformations caused by climate change;

    (e)the measures to ensure that all DNSH criteria for this activity are achieved;

    (f)consideration of societal issues (including preservation of landscape, consultation of stakeholders in accordance with the terms and conditions laid down in national law);

    (g)where applicable, a description of enhanced ecosystem services, such as carbon storage, water purification, flood protection, erosion prevention, pollination, recreational opportunities, and wider socio-economic benefits;

    (h)a monitoring scheme with specific and relevant indicators, allowing to measure progress towards achieving the conservation objectives and an identification of corrective measures as necessary;

    (i)the persons and organisations involved in the management or restoration of the area and, if relevant, the necessary collaborations or partnerships to put in place to achieve the conservation objectives;

    (j)the measures taken to ensure transparency about the conservation objectives, the conservation measures and the monitoring and its results;

    (k)the funding necessary for implementing the conservation measures, for the monitoring of the area and its audit.

    3.2. Where the management plan or the equivalent instrument does not contain all the elements specified in point 3.1, the information is provided by the operator of the activity.

    4. Audit

    4.1. The initial description of the conservation area and the management plan or equivalent instrument specified in points 2 and 3 are verified by an independent third-party certifier at the start of the conservation activity.

    4.2. At the end of the duration of the management plan or equivalent instrument and at least every ten years, the achievement of the objectives set at the start of the management plan and the respect of the DNSH criteria are verified.

    The verification includes an updated detailed description of the ecological conditions of the area as specified in point 2, an evaluation of the effectiveness of the conservation measures, and of the achievement of the conservation objectives, an evaluation of an updated version of the management plan or equivalent instrument, and the recommendations for the next management plan or equivalent instrument.

    4.3. The verification in accordance with points 4.1 and 4.2 is carried out by either of the following:

    (a)the relevant national competent authorities;

    (b)an independent third-party certifier, at the request of national authorities or the operator of the activity.

    In order to reduce costs, audits may be performed together with any forest certification, land-use certification, biodiversity certification, climate certification or other audit.

    The independent third-party certifier may not have any conflict of interest with the owner or the funder and may not be involved in the development or operation of the activity.

    As a result of the verification, the certifier issues an audit report.

    5. Guarantee of permanence

    5.1. In accordance with national law, the area on which the activity takes place is covered by one of the following measures:

    (a)the area is classified as a protected area in line with the IUCN Protected Area Categories System 8 , as a Natura 2000 site under Directive 92/43/EEC, or as an Other Effective area-based Conservation Measure (OECM) 9 , by national law or under an international convention to which the country is signatory and is effectively managed to prevent deterioration and enable the recovery of species and habitats or habitats of species;

    (a)the area is destined to restoration or conservation in a statutory land, freshwater or maritime use plan approved by the competent authorities;

    (b)the area is the subject to a public or private contractual arrangement that can ensure that the conservation objectives can be achieved and maintained.

    5.2. The operator of the area where the conservation activity takes place commits that a new management plan or equivalent instrument in line with the conservation objectives will be produced before the end of the previous plan.

    6. Additional minimum requirements

    6.1. The offsetting of the impacts of another economic activity is excluded under this activity 10 . Only net biodiversity gains resulting from conservation/restoration can be accounted for as substantial contribution under this activity 11 .

    6.2. The introduction of invasive alien species is prevented or their spread is managed in accordance with Regulation (EU) No 1143/2014.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    The activity does not involve the degradation of land with high carbon stock 12  nor the degradation of marine environment with high carbon stock.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (4) Transition to a circular economy

    N/A

    (5) Pollution prevention and control

    The use of pesticides is minimised and alternative approaches or techniques, which may include non-chemical alternatives to pesticides are favoured, in accordance with Directive 2009/128/EC, with exception of occasions where the use of pesticides is needed to control outbreaks of pest and diseases.

    The activity minimises the use of fertilisers, including manure, to ensure it does not go beyond what is necessary to achieve the conservation and restoration objectives of the area and complies with the Codes of Good Agricultural Practices and with the Nitrates Action Plans in Nitrates Vulnerable Zones established in accordance with Council Directive 91/676/EEC 13 . The activity complies with Regulation (EU) 2019/1009 or national rules on fertilisers or soil improvers for agricultural use.

    Well documented and verifiable measures are taken to avoid the use of active ingredients that are listed in Annex I, part A, of Regulation (EU) 2019/1021 14 , the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade, the Minamata Convention on Mercury, the Montreal Protocol on Substances that Deplete the Ozone Layer, and of active ingredients that are listed as classification Ia (‘extremely hazardous’) or Ib (‘highly hazardous’) in the WHO recommended Classification of Pesticides by Hazard 15 .

    Pollution of water and soil is prevented and cleaning up measures are undertaken when pollution occurs.

    The activity complies with the relevant national law on active ingredients.

    2.Accommodation activities

    2.1.Hotels, holiday, camping grounds and similar accommodation

    Description of the activity

    The provision of short-term tourism 16  accommodation with or without associated services, including cleaning, food and beverage services, parking, laundry services, swimming pools and exercise rooms, recreational facilities as well as conference and convention facilities.

    This includes accommodation provided by:

    (a)hotels and motels of all kinds;

    (b)holiday homes;

    (c)visitor flats, bungalows, cottages and cabins;

    (d)youth hostels and mountain refuges;

    (e)campgrounds and trailer parks;

    (f)space and facilities for recreational vehicles;

    (g)recreational camps and fishing and hunting camps;

    (h)protective shelters or plain bivouac facilities for placing tents or sleeping bags.

    This category does not include:

    (a)provision of homes and furnished or unfurnished flats or apartments for more permanent use, typically on a monthly or annual basis;

    (b)cruise ships.

    Conservation or restoration offsets of impacts defined at the stage of formal authorisation of the tourism activity are not considered as a contribution to conservation or restoration measures.

    The economic activities in this category could be associated with several NACE codes, in particular I55.10, I55.20 and I55.30 in accordance with the statistical classification of economic activities established by Regulation (EC) No.1893/2006.

    Technical screening criteria

    Substantial contribution to protection and restoration of biodiversity and ecosystems

    1. Contribution to conservation or restoration activities

    1.1. The activity contributes to conservation or restoration measures which comply with the technical screening criteria for activity “Conservation, including restoration, of habitats, ecosystems and species” set out in Section 1.1 of this Annex, in clearly identified areas, within or in the proximity of the same tourism destination 17 as the accommodation. The area can be any type of area with high nature conservation value covered by a management plan or an equivalent instrument such as a restoration plan (referred to “conservation area” below).

    1.2. The activities contributing to conservation or restoration measures as referred to in point 1.1. are defined in a specific contractual agreement or equivalent instrument between the operator of the activity and the organisation in charge of the conservation or restoration of the area. The agreement covers a minimum of five years and is regularly reviewed, in any case at least every five years. It defines clear time-bound targets for contribution to the conservation or restoration area. The contribution to conservation or restoration measures as referred to in point 1.1. can be financial or in kind and may take one of the following forms:

    (a)offer or organisation of visits to a conservation area where entrance or permit or user fees are applied; 

    (b)operation of concessions and leases for services directly related to a conservation area (issued by the organisation in charge of the management of the area);

    (c)operation of tourist accommodation establishments within a conservation area but not subject to concession (in agreement with the organisation in charge of the management of the area); 

    (d)offer or management of volunteers for activities directly related to conservation (in accordance with the conservation objectives of the conservation area); 

    (e)offer or management of educational opportunities directly related to conservation and appropriate behaviour (in accordance with the conservation objectives of the conservation area); 

    (f)purchase of products of any kind, including food, beverages, handcrafts, for re-selling or for direct use, derived from sustainable practices in a conservation area, in agreement with the organisation in charge of the management of the area; 

    (g)purchase of merchandise from a conservation area for re-selling (or other commercial arrangements that guarantees that the revenue from selling of merchandise accrues to the conservation area); 

    (h)payment of copyrights, including images or names, directly to the organisation in charge of the management of a conservation area;

    (i)collection of tourists’ voluntary donations to be transferred to a dedicated fund or account set up by the organisation in charge of the management of a conservation area on a regular basis.

    1.3. The percentage (%) contribution defined in the contractual agreement is at least equivalent to:

    (a)1% of the annual turnover of an individual tourist accommodation establishment, where the contractual agreement includes only one establishment;

    (b)0.7% of the annual turnover of an individual tourist accommodation establishment, where the contractual agreement or equivalent is collective and includes a group of two to ten establishments;

    (c)0.5% of the annual turnover of an individual tourist accommodation establishment, where the contractual agreement or equivalent is collective and includes a group of over ten establishments.

    Mandatory financial contributions applied to the activity in the context of the national or local regulatory framework, including eco-taxes or tariffs, are not considered as a contribution to the conservation or restoration activity.

    2. Action plan for contributing to nature conservation

    2.1. The activity has developed and implemented an action plan specific to the tourism service or offer provided, which defines how the activity can be carried out in a way which is compatible with and contributes to the implementation of the management plan or equivalent instrument of the conservation area to which the activity intends to contribute. The plan includes all of the following measures relevant for the conservation or restoration objectives of the area:

    (a)a clear set of objectives and activities aimed at avoiding or minimising direct negative impacts on biodiversity, including an analysis of the carrying capacity or limit of acceptable change 18 of the area developed by the organisation in charge of the conservation or restoration of the area or by the operator of the activity in cooperation with that organisation 19 , including the following elements 20 :

    (i)for visits to natural sites: avoiding direct damage on ecosystems or habitats through management of tourist flows and movements;

    (ii)for wildlife interaction:

    avoiding direct harm and disturbance through detrimental actions such as animal feeding, destruction or damaging eggs and nests, destruction or removal of plants or corals;

    avoiding indirect harm and disturbance on species from tourists’ local movements, such as littering, noise, plastic, chemical or light pollution;

    prevention and avoidance of introduction of invasive alien species 21 ;

    (iii)for wildlife harvesting and trade 22 : protected wildlife species are not harvested, consumed, sold;

    (b)where applicable, a description of partnership agreements with conservation management entities, local NGOs or communities to contribute to the conservation or restoration of the area to which it intends to contribute;

    (c)a biodiversity information and awareness plan linked to the specific impacts arising from tourism activities 23 ;

    (d)a clear framework for the continuous monitoring and measuring of the effectiveness of the contribution, including an adaptive approach allowing for the identification of corrective actions, where necessary.

    3. Sustainable Supply Chain and Environmental Management System

    3.1. The establishment has a fair share of products in line with market best practices (such as food and beverages, wood, including furniture, paper, board and plastic products) certified according to environmental standards 24 . The establishment commits to a continuous improvement of the share of the products certified by an independent third party.

    3.2. For accommodation establishments with over 50 employees, the activity complies with one of the following criteria:

    (a)the establishment has an environmental management system (EMS) requiring third party certification, such as the EU Eco-Management and Audit Scheme 25  (EMAS), ISO 14001:2015 26 or equivalent, aligned with best environmental management practice and benchmark performances such as the EMAS Reference Document for the Tourism Sector 27 or equivalent national or international standard;

    (b)the establishment was awarded with an EU Ecolabel for tourist accommodation or an equivalent EN ISO 14024:2018 28 type I Ecolabel or an equivalent voluntary label meeting equivalent requirements 29 .

    4. Minimum requirements

    4.1. An Environmental Impact Assessment (EIA) or a screening 30  has been completed in accordance with Directive 2011/92/EU 31 . Where an EIA has been carried out, the required mitigation and compensation measures for protecting the environment are implemented.

    The activity does not have significant adverse effects on protected areas (UNESCO World Heritage sites, Key Biodiversity Areas, as well as other protected areas than Natura 2000 sites) and protected species, based on an assessment of its impact that takes into account the best available knowledge 32 . The activity is not detrimental to the recovery or maintenance of the populations of the species and of the habitat types protected under national law at a favourable conservation status.

    In the Union, in relation to Natura 2000 sites, the activity does not have significant effects on Natura 2000 sites in view of their conservation objectives on the basis of an appropriate assessment carried out in accordance with Article 6(3) of Directive 92/43/EEC.

    In the Union, in any area, the activity is not detrimental to the recovery or maintenance of the populations of the species protected under Directives 92/43/EEC and 2009/147/EC at a favourable conservation status. The activity is also not detrimental to the recovery or maintenance of the habitat types protected under Directive 92/43/EEC at a favourable conservation status.

    4.2. The introduction of invasive alien species is prevented or their spread is managed in accordance with Regulation (EU) No 1143/2014.

    4.3. Recreational hunting and fishing activities are allowed only where they are explicitly included as part of the conservation or management plan of the conservation area as established by the management entity and carried out in accordance with applicable Union and national law.

    5. Audit

    At the beginning of the activity and at least every five years thereafter, the compliance with the technical screening criteria is controlled by the relevant national competent authorities or by an independent third-party certifier, such as a dedicated certification or accreditation scheme, at the request of national authorities or the operator of the activity.

    The independent third-party certifier may not have any conflict of interest, in particular with the owner or the funder, and may not be involved in the development or operation of the activity.

    In order to reduce costs, audits may be performed together with any other audit.

    Do no significant harm (‘DNSH’)

    (1) Climate change mitigation

    For buildings built before 31 December 2020, the building has at least an Energy Performance Certificate (EPC) class C. As an alternative, the building is within the top 30% of the national or regional building stock expressed as operational Primary Energy Demand (PED) and demonstrated by adequate evidence, which at least compares the performance of the relevant asset to the performance of the national or regional stock built before 31 December 2020 and at least distinguishes between residential and non-residential buildings.

    For buildings built after 31 December 2020, the Primary Energy Demand (PED) 33 defining the energy performance of the building resulting from the construction does not exceed the threshold set for the nearly zero-energy building (NZEB) requirements in national regulation implementing Directive 2010/31/EU. The energy performance is certified by an Energy Performance Certificate (EPC).

    The activity does not involve the degradation of land with high carbon stock 34  nor the degradation of marine environment with high carbon stock.

    (2) Climate change adaptation

    The activity complies with the criteria set out in Appendix A to this Annex.

    (3) Sustainable use and protection of water and marine resources

    The activity complies with the criteria set out in Appendix B to this Annex.

    (4) Transition to a circular economy

    The accommodation establishment:

    (a)does not make any use of or offer to its guests any of the items listed in Part B of Annex to Directive (EU) 2019/904 of the European Parliament and of the Council 35 ;

    (b)separates at source paper, metal, plastic, glass and biowaste where separate collection for these materials is available in the area 36 ;

    (c)has a food waste prevention plan with a specific time-bound quantitative target of reduction of food waste 37 .

    (5) Pollution prevention and control

    The activity complies with the criteria set out in Appendix C to this Annex.

    The activity is in line with Directive (EU) 2015/2193 of the European Parliament and of the Council 38 .

    Noise, plastic, light and chemical pollution are minimised.



    Appendix A: Generic criteria for DNSH to climate change adaptation

    I. Criteria

    The physical climate risks that are material to the activity have been identified from those listed in the table in Section II of this Appendix by performing a robust climate risk and vulnerability assessment with the following steps:

    (a)    screening of the activity to identify which physical climate risks from the list in Section II of this Appendix may affect the performance of the economic activity during its expected lifetime;

    (b)    where the activity is assessed to be at risk from one or more of the physical climate risks listed in Section II of this Appendix, a climate risk and vulnerability assessment to assess the materiality of the physical climate risks on the economic activity;

    (c)    an assessment of adaptation solutions that can reduce the identified physical climate risk.

    The climate risk and vulnerability assessment is proportionate to the scale of the activity and its expected lifespan, such that:

    (a)    for activities with an expected lifespan of less than 10 years, the assessment is performed, at least by using climate projections at the smallest appropriate scale;

    (b)    for all other activities, the assessment is performed using the highest available resolution, state-of-the-art climate projections across the existing range of future scenarios 39 consistent with the expected lifetime of the activity, including, at least, 10 to 30 years climate projections scenarios for major investments.

    The climate projections and assessment of impacts are based on best practice and available guidance and take into account the state-of-the-art science for vulnerability and risk analysis and related methodologies in line with the most recent Intergovernmental Panel on Climate Change reports 40 , scientific peer-reviewed publications, and open source 41 or paying models.

    For existing activities and new activities using existing physical assets, the economic operator implements physical and non-physical solutions (‘adaptation solutions’), over a period of time of up to five years, that reduce the most important identified physical climate risks that are material to that activity. An adaptation plan for the implementation of those solutions is drawn up accordingly.

    For new activities and existing activities using newly-built physical assets, the economic operator integrates the adaptation solutions that reduce the most important identified physical climate risks that are material to that activity at the time of design and construction and has implemented them before the start of operations.

    The adaptation solutions implemented do not adversely affect the adaptation efforts or the level of resilience to physical climate risks of other people, of nature, of cultural heritage, of assets and of other economic activities; are consistent with local, sectoral, regional or national adaptation strategies and plans; and consider the use of nature-based solutions 42 or rely on blue or green infrastructure 43 to the extent possible.

    II. Classification of climate-related hazards 44

    Temperature-related

    Wind-related

    Water-related

    Solid mass-related

    Chronic

    Changing temperature (air, freshwater, marine water)

    Changing wind patterns

    Changing precipitation patterns and types (rain, hail, snow/ice)

    Coastal erosion

    Heat stress

    Precipitation or hydrological variability

    Soil degradation

    Temperature variability

    Ocean acidification

    Soil erosion

    Permafrost thawing

    Saline intrusion

    Solifluction

    Sea level rise

    Water stress

    Acute

    Heat wave

    Cyclone, hurricane, typhoon

    Drought

    Avalanche

    Cold wave/frost

    Storm (including blizzards, dust and sandstorms)

    Heavy precipitation (rain, hail, snow/ice)

    Landslide

    Wildfire

    Tornado

    Flood (coastal, fluvial, pluvial, ground water)

    Subsidence

    Glacial lake outburst



    Appendix B: Generic criteria for DNSH to sustainable use and protection of water and marine resources

    Environmental degradation risks related to preserving water quality and avoiding water stress are identified and addressed with the aim of achieving good water status and good ecological potential as defined in Article 2, points (22) and (23), of Regulation (EU) 2020/852, in accordance with Directive 2000/60/EC 45 and a water use and protection management plan, developed thereunder for the potentially affected water body or bodies, in consultation with relevant stakeholders.

    Where an Environmental Impact Assessment is carried out in accordance with Directive 2011/92/EU and includes an assessment of the impact on water in accordance with Directive 2000/60/EC, no additional assessment of impact on water is required, provided the risks identified have been addressed.

    The activity does not hamper the achievement of good environmental status of marine waters or does not deteriorate marine waters that are already in good environmental status as defined in point 5 of Article 3 of Directive 2008/56/EC 46 , taking into account the Commission Decision (EU) 2017/848 in relation to the relevant criteria and methodological standards for those descriptors.



    Appendix C: Generic criteria for DNSH to pollution prevention and control regarding use and presence of chemicals

    The activity does not lead to the manufacture, placing on the market or use of:

    (a) substances, whether on their own, in mixtures or in articles, listed in Annexes I or II to Regulation (EU) 2019/1021, except in the case of substances present as an unintentional trace contaminant;

    (b) mercury and mercury compounds, their mixtures and mercury-added products as defined in Article 2 of Regulation (EU) 2017/852;

    (c) substances, whether on their own, in mixture or in articles, listed in Annexes I or II to Regulation (EC) No 1005/2009;

    (d) substances, whether on their own, in mixtures or in articles, listed in Annex II to Directive 2011/65/EU, except where there is full compliance with Article 4(1) of that Directive;

    (e) substances, whether on their own, in mixtures or in an article, listed in Annex XVII to Regulation (EC) 1907/2006, except where there is full compliance with the conditions specified in that Annex;

    (f) substances, whether on their own, or in mixtures or in an article, in a concentration above 0,1% weight by weight (w/w), and meeting the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 and that were identified in accordance with Article 59(1) of that Regulation for a period of at least 18 months, except if it is assessed and documented by the operators that no other suitable alternative substances or technologies are available on the market, and that they are used under controlled conditions 47 .

    In addition, the activity does not lead to the manufacture, presence in the final product or output, or placing on the market, of other substances, whether on their own, or in mixtures or in an article, in a concentration above 0,1% weight by weight (w/w), that meet the criteria of Regulation (EC) No 1272/2008 for one of the hazard classes or hazard categories mentioned in Article 57 of Regulation (EC) No 1907/2006, except if it is assessed and documented by the operators that no other suitable alternative substances or technologies are available on the market, and that they are used under controlled conditions 48 .

    (1)    ‘Habitat’ means a terrestrial or aquatic area distinguished by geographic, abiotic and biotic features, whether entirely natural or semi-natural, in accordance with Article 1, point (b) of Directive 92/43/EEC.
    (2)    ‘Ecosystems’ means a dynamic complex of plant, animal, and microorganism communities and their non-living environment, interacting as a functional unit, and includes habitat types, habitats of species and species populations.
    (3)    Article 2 ‘Use of Terms’ of the Convention on Biological Diversity (CBD), (version of [adoption date]: available at https://www.cbd.int/convention/articles/?a=cbd-02.)
    (4)    ‘Good condition’ means a state where the key characteristics of an ecosystem, namely its physical, chemical, compositional, structural and functional state, and its landscape and seascape characteristics, reflect the high level of ecological integrity, stability and resilience necessary to ensure its long-term maintenance, without prejudice to more specific definitions of ‘good condition’ under different legal frameworks.
    (5)    Habitat of a species’ means an environment defined by specific abiotic and biotic factors, in which the species lives at any stage of its biological cycle.
    (6)    Regulation (EU) No 691/2011 of the European Parliament and of the Council of 6 July 2011 on European environmental economic accounts (OJ L 192, 22.7.2011, p. 1).
    (7)    The restoration plan can be part of a management plan. Where the area is covered by a management plan, no additional restoration plan is required.
    (8)    See https://www.iucn.org/theme/protected-areas/about/protected-area-categories, (version of [adoption date]).
    (9)    The definition of OECM and a guidance for its application is set out in Decision 14/8 of the UN Convention on Biological Diversity (version of [adoption date]: https://www.cbd.int/doc/decisions/cop-14/cop-14-dec-08-en.pdf).
    (10)    Biodiversity offsets are measurable conservation outcomes resulting from measures designed to compensate for residual, unavoidable, adverse biodiversity impacts arising from an activity or project after appropriate prevention and mitigation measures have been taken. The goal of biodiversity offsets is to conserve the same biodiversity values (habitats, species or ecosystems) that are negatively impacted by the activity or project.
    (11)    This can include additional conservation/restoration outcomes beyond offsetting measure.
    (12)    Land with high-carbon stock’ means wetlands, including peatland, and continuously forested areas within the meaning of Article 29(4)(a), (b) and (c) of Directive (EU) 2018/2001.
    (13)    Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1).
    (14)    Which implements in the Union the Stockholm Convention on persistent organic pollutants (OJ L 209, 31.7.2006, p. 3.).
    (15)    The WHO Recommended Classification of Pesticides by Hazard (version 2019), (version of [adoption date]: https://apps.who.int/iris/bitstream/handle/10665/332193/9789240005662-eng.pdf?ua=1).
    (16)    ‘Tourism’ means the activity of visitors taking a trip to a main destination outside their usual environment, for less than a year, for any main purpose, including business, leisure or other personal purpose, other than to be employed by a resident entity in the place visited, see Eurostat Statistics Explained glossary, (version of [adoption date]: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:Tourism).
    (17)    ‘Tourism destination’ is defined in this context as a geographic area visited, consisting of a set of resources and attractions that usually is promoted by a Destination Management Organisation or by a local, subnational or national tourism organisation.
    (18)    The ‘carrying capacity’ is defined as the maximum number of people that may visit a tourist destination at the same time, without causing destruction of the physical, economic, socio-cultural environment and an unacceptable decrease in the quality of visitors' satisfaction. (UNEP/MAP/PAP, 1997).
    (19)    The carrying capacity can be also developed as part of the Environmental Impact Assessment (EIA) or screening refereed to in point 4.1.
    (20)    In line with the Global Sustainable Tourism Council (GSTC) Industry Criteria for Hotels, (version of [adoption date]: https://www.gstcouncil.org/gstc-criteria/gstc-industry-criteria-for-hotels/).
    (21)    The introduction of invasive alien species is prevented or their spread is managed in accordance with Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien speci