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

1. The activity manufactures, installs, provides maintenance, repairs or professional services for leakage control technologies in new or existing water supply systems, aimed at controlling the pressure in district metering areas (DMAs) of the water supply system to a minimum pressure. The leakage control technologies include 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.

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, in Commission Implementing Decision (EU) 2022/679 3 , and in 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 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 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.

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 status and good ecological potential of the affected water bodies, including bodies of surface water and groundwater, in accordance with Directive 2000/60/EC or to preventing the deterioration of water bodies of water that already have good status and does not result in a deterioration of the status of the affected water bodies 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 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.

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

1. 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, rainwater run-offs from roofs, rainwater run-offs from motorways, 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 .

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. 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’ 14 . 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 periodically reviewed by an ad-hoc committee composed of sector experts (including experts in water ecology) and the relevant regional or local managing authorities 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 sea with high carbon stock 15 .

(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 put in place to prevent and manage construction and demolition waste in accordance with the waste hierarchy and in line with good industry practice, as laid down, for instance, in the EU Construction and Demolition Waste Protocol 16 .

(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 17 , safe where the use of pesticides is needed to control outbreaks of pest and diseases. The activity minimises the use of fertilisers anddoes 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 areas designated by the national competent authority for conservation, the activity complies with the conservation objectives for those areas.

There is no conversion of habitats specifically sensitive to biodiversity loss or with high conservation value, or of areas set aside for the restoration of such habitats in accordance with national law. The activity provides for maintaining and possibly enhancing biodiversity in accordance with national and local provisions, including the following:

(a)ensuring the good ecological status, good environmental status or favourable conservation status of habitats and species and ensuring maintenance of typical habitat species; 

(b)the exclusion of the use or release of invasive species.

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

1. The economic activity manufactures, develops, installs, deploys, maintains, repairs and 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 water metering 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 19 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

A waste management plan is in place and ensures maximal recycling at end of life of electrical and electronic equipment, including through contractual agreements with recycling partners, reflection in financial projections or official project documentation.

At its end of life, the equipment undergoes preparation for re-use, 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 of the European Parliament and of the Council 20 .

(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 21  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 22 , except where the concentration values by weight in homogeneous materials do not exceed those listed in that Annex.

(6) Protection and restoration of biodiversity and ecosystems

N/A

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

Substantial contribution to the transition to a circular economy

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

(a)design for reuse: the packaging product has been designed to be reusable within a reuse system 1 . 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, number 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;

(b)use of circular feedstock: at least 65% of the packaging product by weight consists of mechanically recycled post-consumer material for non-contact sensitive packaging and at least 50% for contact sensitive packaging 2 . Where producing mechanically recycled material is not technically feasible or economically viable, the product may consist of at least 65% of chemically recycled material;

(c)use of bio-waste feedstock: at least 65% of the packaging product by weight consists of sustainable bio-waste feedstock 3 . 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 produced is recyclable in practice and at scale, and complies with all of the criteria specified below.

2.1. The unit of packaging 4 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 the same or similar 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 5  target for plastic packaging waste set by the Directive 94/62/EC of the European Parliament and of the Council 6 , 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 7 .

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 8 ;

(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 disruptors for human health category 1 or 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;

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

(l)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. The use of compostable materials in packaging applications is considered sustainable only for very lightweight plastic carrier bags, tea bags, coffee pads and sticky labels attached to fruit and vegetables.

Do no significant harm (‘DNSH’)

(1) Climate change mitigation

9 10 11 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 or, alternatively, using ISO 14067:2018 or ISO 14064-1:2018. 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.

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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 12 in relation to the relevant criteria and methodological standards for those descriptors.

(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;

(b)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.

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 66/2010/EC of the European Parliament and of the Council 21 , the manufacturer 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 economic operator has not used them, the economic activity manufacturing electrical and electronic equipment complies with all of the following criteria:

2.1. Design for long lifetime

2.1.1. 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 case of:

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

2.1.3. Software is not used in order to affect the replacement of a portable battery, and correct battery replacement does not affect 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, manufacturer ensures that products have the highest reparability class 24 .

2.2.2. Manufacturers provide 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)electronic board diagrams;

(i)technical manual of instructions for repair, including marking of the individual steps;

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

(k)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, 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, manufacturers provide 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 exist, manufacturer ensures access to independent certified professional repairers. The manufacturer’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 for consumer use, the manufacturer provides commercial guarantee for one additional year compared to requirements under 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, data encryption is required, alongside a software function that resets the device to its factory settings and erases by default the encryption key.

2.3.2. The stored data can be easily and fully transferred to another product.

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 manufacturer 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 components rich in critical raw materials, information is provided on the presence and weight of critical raw materials 29 .

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) components rich with critical raw materials are easy to access and to remove from product;

(g)parts that reduce the recyclability according to the reference end-of-life treatment scenario, 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 Directive 2023/XX/EC of the European Parliament and of the Council 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.

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 electric 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 or participates in a 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.

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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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.

Substantial contribution to the transition to a circular economy

1. For the process integrated at the WWTP, covering mainly 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.

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 . 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 ulterior 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 ulterior 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.

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.

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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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

Substantial contribution to the transition to a circular economy

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

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

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 .

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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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 .

(6) Protection and restoration of biodiversity and ecosystems

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

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, or upgraded to bio-methane for use as a fuel (possibly with direct injection in the gas grid) or 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.

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 and disposal of hazardous waste; 

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

2. 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 63  and has applied to be included in the European List of ship recycling facilities.

3. 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.

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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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 storage, 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.

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 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 and prevention control and 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.

Substantial contribution to the transition to a circular economy

74 75 76 77 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. At least 90 % (by weight) of the non-hazardous construction and demolition waste generated on the construction site is prepared for re-use or recycling. 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 using the Level 2 reporting format for different waste streams.

78 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 80 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 and 2.4 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 81 . 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, 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 biobased products, 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.

82 The thresholds are calculated by subtracting the secondary 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. Where a construction product is re-used, it is to be counted as comprising zero primary raw material. Compliance with this criterion is demonstrated by reporting in accordance with the Level(s) common EU framework for indicator 2.1.

83 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. The information is stored in a digital format and is made available to the client. 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) 84 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 85 . 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 86 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 87 or ISO 16000-3:2011 88 or other equivalent standardised test conditions and determination methods. 89  

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 90 . 

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 91 ;

(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 92 or the IUCN Red List 93 ;

(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 94 .

Substantial contribution to the transition to a circular economy

95 96 97 98 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. At least 70% (by weight) of the non-hazardous construction and demolition waste generated on the construction site is prepared for re-use or recycling. 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 using the Level 2 reporting format for different waste streams.

99 2. The life cycle Global Warming Potential (GWP) 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. 

100 101 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 and 2.4 at Level 2.

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

103 5. The use of primary raw material in the renovation of the building is minimised through the use of secondary raw materials. 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 concrete, natural or agglomerated stone a maximum of 85% of the material come from primary raw material;

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

(c)for biobased products, a maximum of 90% of the material come from primary raw material;

(d)for 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.

104 The thresholds are calculated by subtracting the secondary material from the total amount of each material 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. Where a construction product is re-used, it is to be counted as comprising zero primary raw material. Compliance with this criterion is demonstrated by reporting in accordance with the Level(s) common EU framework for indicator 2.1.

105 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. The information is stored in a digital format and is made available to the client. 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 106 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 107 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

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 2.2 109 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.

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

111 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 Protocol.

112 113 114 115 4. At least 90 % (by weight) of the non-hazardous demolition waste generated on the demolition site is prepared for re-use or recycling. 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 3 reporting format for different waste streams. Alternatively, at least 95% for mineral fraction and 70% for the non-mineral fraction for 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 panels40, or laminated boards41 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 shall draw 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 request.

(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.

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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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.

Substantial contribution to the transition to a circular economy

119 120 1. Where main road elements (binder course, surface course or concrete slabs) are demolished or removed, 100% (by mass in kilogrammes) of the non-hazardous waste generated onsite is prepared for re-use or recycling. 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 road elements are newly installed after demolition or removal, at least 50% (by mass in kilogrammes) of the structural road elements used are re-used or recycled materials.

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.

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

5. The use of primary raw material for road furniture is minimised through the use of re-used or recycled products. The operator of the activity ensures that for metals, such as steel barriers, a maximum of 30% of the material come from 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, dust and pollutant emissions during construction and 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 122 .

(6) Protection and restoration of biodiversity and ecosystems

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

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 124 . At least 90 % (by weight) of the non-hazardous construction waste deriving from concrete products is prepared for re-use 125 or recycling 126 . 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 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 2.3 127 and 2.4 128 at Level 2.

3. The use of primary raw material is minimised through the use of recycled products. For concrete, a maximum of 70% of the material comprises primary raw material. This criterion applies to in-situ poured concrete, pre-cast products, and all constituent materials, including any reinforcement.

4. The re-used or recycled materials is 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 129 to provide Environmental Product Declarations 130 . The information is stored in a digital format and is made available to the client. 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 equipped with monitoring functions 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.

131 The concrete used in this activity includes cement, for which the greenhouse gas emissions from the production processes are:

(a)for grey cement clinker, lower than 0,816 132 tCO2e per tonne of grey cement clinker;

(b)for cement from grey clinker or alternative hydraulic binder, lower than 0,530 133 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

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 134 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 135 or ISO 16000-3:2011 136 or other equivalent standardised test conditions and determination methods. 137  

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, dust and pollutant emissions during construction 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 138 .

(6) Protection and restoration of biodiversity and ecosystems

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

139 Where protective areas of fauna and flora are affected, an Environmental Integration and a Restoration Plan is developed and implemented in order to restore ecosystems across land and sea after completion of the proper civil engineering measure. For this, measures are taken, such as sustainable forest management and avoidance of deforestation, wildlife passages across the construction or nature-based solutions that protect, sustainably manage, and restore natural or modified ecosystems, and that address societal challenges effectively.

Substantial contribution to the transition to a circular economy

1. The economic activity provides users and operators with capabilities specified below. Where these capabilities are part of a broader software or IT/OT offering, only specific software add-ons implementing these capabilities qualify. Where multiple capabilities are listed under a single bullet point below, all capabilities are to be met for the system or software to qualify.

2. For remote monitoring and predictive maintenance systems, the following capabilities qualify:

(a)capturing sensor data from sensors (such as power, temperature, vibration, video, sound, viscosity) built into a product, equipment, or infrastructure; collecting and transmitting such data to a data repository (edge or cloud) for the purpose of data analysis; alerting the user to abnormal sensor values, and assessing the status of the product, equipment, or infrastructure, detecting wear and tear or electrical issues, or 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.

142 IT/OT systems aimed at (i) monitoring for the replacement of consumables, 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, the following capabilities qualify:

(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 143 or ISO 14040 144 , 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, the following capabilities qualify:

(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 145 or ISO 14040 146 ;

(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, the following capabilities qualify:

(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 optimizing 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;

(f)tracking the composition of a product over its life cycle with the predominant objective to manage its global level of circularity.

6. For supplier management software, the following capabilities qualify:

(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 147 ;

(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, the following capabilities qualify:

(a)supporting the monitoring and assessment of the circularity performance 148 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)a waste management plan is in place and ensures maximal recycling at end of life of electrical and electronic equipment, including through contractual agreements with recycling partners, reflection in financial projections or official project documentation;

(b)at its end of life, the equipment undergoes preparation for re-use, 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

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

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 153 (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 154 .

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 of the European Parliament and of the Council 155 , 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

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 157 (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 158 , 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 159 . The system for reuse is established in a way that ensures the possibility of reuse in closed-loop or open-loop system and is consistent with requirements for such system specified under point 1.a of the criteria for manufacture of plastic packaging goods set in Section 1.1. of this Annex.

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

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 161 .

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 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.

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 163 , the EU Eco-Management and Audit Scheme (EMAS) in accordance with Regulation (EC) 1221/2009 of the European Parliament and of the Council 164 or equivalent and a Quality management system using ISO 9001:2015 165 .

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

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 166 (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 167 , 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 168 . The system for reuse is established in a way that ensures the possibility of reuse in closed-loop or open-loop system and is consistent with requirements for such system specified under point 1.a of the criteria for manufacture of plastic packaging goods set in Section 1.1. of this Annex.

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 should comply with specific emissions of CO2, as defined in Article 3(1), point (h), of Regulation (EU) 2019/631 of the European Parliament and of the Council 169 lower than 50gCO2/km (low- and zero-emission light-duty vehicles);

(b)vehicles of category L(82) 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(83);

(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 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). 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

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. The product offered through this activity complies with one of the following criteria:

(a)a lifespan of at least twice the Union average for that product category, accounting for differences between Business to Business (B2B) and Business to Customers (B2C) contexts, under the condition of an average use intensity;

(b)a use intensity of at least twice the Union average for that product category, accounting for differences between B2B and B2C contexts, under the condition of an average lifespan;

(c)a combination of extended lifespan and increased use intensity, so that ‘lifespan times use intensity’ is at least twice the Union average, accounting for differences between B2B and B2C contexts.

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 170 , 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 171 . The system for reuse is established in a way that ensures the possibility of reuse in closed-loop or open-loop system and is consistent with requirements for such system specified under point 1.a of the criteria for manufacture of plastic packaging goods set in Section 1.1. of this Annex.

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

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’ 174 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

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

Substantial contribution to pollution prevention and control

1. The activity complies with 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, available in the market 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 ;

(c)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;

(d)the best available techniques (BAT) conclusions for common waste water and waste gas treatment/management systems in the chemical sector 10 ;

(e)the Best Available Techniques Reference Document (BREF) for the Large Volume Inorganic Chemicals – Solids and Others industry 11 ;

(f)the Best Available Techniques Reference Document (BREF) for the manufacture of Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers 12 ;

(g)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 in pharmaceutical 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 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 measures of other 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 drug substances are made from substances listed in Sections 3.10 to 3.16 of Annex I to Commission Delegated Regulation (EU) 2021/2139, the GHG emissions do not exceed the limites 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

5. 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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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.

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 pharmaceutical preparation complies with the following requirements set out in points 1.1.1. and 1.1.2.:

1.1.1. The pharmaceutical preparation complies with one of the following requirements:

(a)the ingredients that constitute the formulation of the pharmaceutical preparation 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 pharmaceutical preparation 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 pharmaceutical preparation qualifies as an appropriate substitute to another pharmaceutical preparation, within the same therapeutic area or the substance class, available in the market 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 pharmaceutical preparation 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 pharmaceutical preparation, 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 drug substance 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 pharmaceuticals, including by providing relevant information to the downstream users on appropriate disposal of unused pharmaceuticals.

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;

(c)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;

(d)the best available techniques (BAT) conclusions for common waste water and waste gas treatment/management systems in the chemical sector 29 ;

(e)the Best Available Techniques Reference Document (BREF) for the Large Volume Inorganic Chemicals – Solids and Others industry 30 ;

(f)the Best Available Techniques Reference Document (BREF) for the manufacture of Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers 31 ;

(g)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 pharmaceutical 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 measures of other 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 pharmaceutical products are made from substances listed in Sections 3.10 to 3.16 of Annex I 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

5. 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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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.

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.

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.

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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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 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.

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 45  or the best available techniques (BAT) conclusions for waste incineration 46 .

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; 

(b)documented sampling procedure consistent with relevant standards, such as EN 14899:2005 47 ;

(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 48 .

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 49 (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 50 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 51 , 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 52 .

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 53 . 

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 Article 2, points (21) of Regulation (EU) 2020/852 and in accordance with Directive 2008/56/EC, which requires in particular that the appropriate measures are taken to prevent or mitigate impacts in relation to the descriptors laid down in Annex I to that Directive, taking into account the Commission Decision (EU) 2017/8489 in relation to the relevant criteria and methodological standards for those descriptors.

(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.