EUROPEAN
COMMISSION

Brussels, XXX[…](2023) XXX draft
ANNEX 3

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

EN

EN

TABLE OF CONTENTS
ANNEX III ................................................................................................................................. 2

EN

1.

Manufacturing .............................................................................................................. 2

1.1.

Manufacture of active pharmaceutical ingredients (API) or drug substances ............. 2

1.2.

Manufacture of pharmaceutical products ..................................................................... 8

2.

Water supply, sewerage, waste management and remediation activities .................. 15

2.1.

Collection and transport of hazardous waste ............................................................. 15

2.2.

Treatment of hazardous waste ................................................................................... 17

2.3.

Remediation of legally non-conforming landfills and abandoned or illegal waste
dumps ......................................................................................................................... 21

2.4.

Remediation of contaminated sites and areas ............................................................ 26

1

ENANNEX III
Technical screening criteria for determining the conditions under which an economic
activity qualifies as contributing substantially to pollution prevention and control andfor determining whether that economic activity causes no significant harm to any of theother environmental objectives

1.

MANUFACTURING

1.1.

Manufacture of active pharmaceutical ingredients (API) or drug substances

Description of the activity
Manufacture of any substance or mixture of substances intended to be used in the
manufacture of a pharmaceutical product including receipt of materials, processing or
packaging of the API and related controls.
The economic activities in this category could be associated with NACE code C21.1 inaccordance with the statistical classification of economic activities established by Regulation(EC) No 1893/2006.
Technical screening criteria
Substantial contribution to pollution prevention and control
1. The activity complies with the requirements specified below relating to productsubstitution.
1.1. The API complies with one of the following requirements:(a)the API is a naturally occurring substance, such as vitamins, electrolytes, aminoacids, peptides, proteins, nucleotides, carbohydrates and lipids a and, in line with theEuropean 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 environment2;(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:

1

2

EN

European Medicines Agency Guidelines on the environmental risk assessment of medicinal products
for human use, available at https://www.ema.europa.eu/en/environmental-risk-assessment-medicinalproducts-human-use-scientific-guideline.
Key metabolites are human metabolites likely to be excreted into the environment. Those metabolites
are identified in (non-)clinical studies on the metabolism of pharmaceuticals available in the marketing
authorization applications. Such metabolites are to be identified according to
EMA/CPMP/ICH/286/1995, page 8. Key transformation products (TP) of these key human metabolitesof the parent compound (API) are those that exceed 10% of Dissolved Organic Carbon (DOC) or Total
Organic Carbon (TOC) of the parent compound.

2

EN

(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 Biodegradability3, in accordance with the pass value for readybiodegradability 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 Chemicals5 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 therapeuticarea 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 conditions6.
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 midpoint of the BAT-AEL ranges7 set out in:
(a)

3

4

5

6

7

EN

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

OECD Guidelines for the Testing of Chemicals, Test 301 (A-F), Ready Biodegradability, available athttps://www.oecd.org/chemicalsafety/risk-assessment/1948209.pdf. OECD 301 (A-F) test is used to
identify substances which are assumed to rapidly and ultimately biodegrade, i.e., mineralised underaerobic environmental conditions).
Higher-tier studies (OECD 308) result with so-called half-lives indicating the time after which 50 %biodegradation of the API is achieved. Half-lives acceptable to demonstrate sufficiently quick
biodegradation, i.e., non-persistence, according to the Regulation (EC) No 1907/2006, Annex XIII,
which is also referenced in the EMA ERA guideline, apply.
OECD Guidelines for the Testing of Chemicals, Test No. 308: Aerobic and Anaerobic Transformationin Aquatic Sediment Systems, available at: https://www.oecd-ilibrary.org/environment/test-no-308aerobic-and-anaerobic-transformation-in-aquatic-sediment-systems_9789264070523-en.
The Commission will review the exceptions from the prohibition from manufacturing, placing on themarket or use of the substances referred to in points (f) and (g) once it will have published horizontal
principles on essential use of chemicals.
The requirements under this point tackle the pollutants identified under the key environmental issues ofeach BREF document or the BAT-AEL of the relevant BAT conclusions Commission Implementing
Decisions. Where BAT-AEL differentiate between “existing” and “new plants”, operators demonstratecompliance with BAT-AEL for new plants. When there is not a BAT-AEL range but a single value,emission levels are below such value. When the BAT-AEL range is expressed as follows: “<x-y unit”(i.e the lower-end BAT-AEL of the range is expressed as ‘lower than’), the mid-point is calculatedusing x and y. Averaging periods are the same as in the BAT-AEL of the BREF documents outlined
above.

3EN(or for existing installations within 4 years of the BATC publication) where relevant
conditions apply8;(c)the Best Available Techniques Reference Document (BREF) for Manufacture ofOrganic Fine Chemicals (OFC)9 for the manufacturing activity under conditions notcovered 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 sector10;(e)

the Best Available Techniques Reference Document (BREF) for the Large Volume
Inorganic Chemicals – Solids and Others industry11;(f)

the Best Available Techniques Reference Document (BREF) for the manufacture of
Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers12;(g)

the Best Available Techniques Reference Document (BREF) for the production of
speciality inorganic chemicals (SIC)13; for the manufacturing activity underconditions 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 inaccordance with the procedure set out in Article 15(4) of Directive 2010/75/EU are notconsidered 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, theoperator applies Continuous Emission Monitoring Systems (CEMS), Continuous Effluent
Quality Monitoring Systems (CEQMS) and other measures ensuring the regular verificationof 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 solvents14 are avoided in pharmaceutical products.

8

9

10

11

12

13

EN

Commission Implementing Decision (EU) 2022/2427 of 6 December 2022 establishing the best
available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament andof the Council on industrial emissions, for common waste gas management and treatment systems in thechemical sector (OJ L 318, 12.12.2022, p. 157).
The Best Available Techniques Reference Document (BREF) for Manufacture of Organic Fine
Chemicals, available at https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/ofc_bref_0806.pdf.
Commission Implementing Decision (EU) 2016/902 of 30 May 2016 establishing best available
techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of theCouncil, for common waste water and waste gas treatment/management systems in the chemical sector(OJ L 152, 9.6.2016, p. 23).
Best Available Techniques (BAT) Reference Document for the Large Volumes Inorganic ChemicalsSolids
and
Othersindustry,(versionof[adoptiondate]:
https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic-s_bref_0907.pdf).
Best Available Techniques (BAT) Reference Document for the manufacture of Large Volume Inorganic
Chemicals
Ammonia,
Acids
andFertilisers(versionof[adoptiondate]:
https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic_aaf.pdf).
The Best Available Techniques Reference Document (BREF) for the production of speciality inorganic
chemicals (SIC), available at https://eippcb.jrc.ec.europa.eu/reference/production-speciality-inorganicchemicals.

4

ENThe maximum solvents loss from total inputs does not exceed a 3% loss. Total volatileorganic 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 forcommon 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 periodicallyqualified 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 ppmv15.
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 otherthan 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 frommanufacturing) 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 thesesubstances and their residues to non-hazardous waste materials are available at the facility andkept up to date.
Do no significant harm (‘DNSH’)

Where the activity involves on-site generation of heat/cool or co(1) Climate change generation including power, the direct GHG emissions of the activity
mitigation
are lower than 270 gCO2e/kWh.
For the refrigerant threshold, the Global Warming Potential does not

14

15

EN

European Medicines Agency ICH guideline Q3C (R8) on impurities: guideline for residual solvents.
Step 5, 2022, available at . https://www.ema.europa.eu/en/documents/scientific-guideline/internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf.
Where the exemption under criterion 1.3 applies.

5

EN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
14067:201816 or ISO 14064-1:201817. Quantified life-cycle GHG
emissions are verified by an independent third party.

(2) Climate change The activity complies with the criteria set out in Appendix A to thisadaptation
Annex.
(3) Sustainable use
and protection ofwater 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 ofwater 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 and2011/92/EU.
The activity implements best practices specified in the Joint ResearchCentre Best Environmental Management Practice for the Public
Administration Sector18.
Where waste water treatment is conducted by an urban wastewater
treatment plant on behalf of the manufacturing plant, it is ensured that:

16

17

18

EN

(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

ISO standard 14067:2018, Greenhouse gases — Carbon footprint of products — Requirements andguidelines for quantification, available at: https://www.iso.org/standard/71206.html.
ISO standard 14064-1:2018, Greenhouse gases — Part 1: Specification with guidance at theorganization level for quantification and reporting of greenhouse gas emissions and removals, available
at: https://www.iso.org/standard/66453.html.
Joint Research Centre, Best Environmental Management Practice for the Public Administration Sector,
2019, available at https://op.europa.eu/en/publication-detail/-/publication/6063f857-7789-11e9-9f0501aa75ed71a1/language-en.

6ENor harm to the health of the staff working in waste water
treatment plants;(c)the urban waste water treatment plant is designed andequipped appropriately to abate the released polluting
substances;(d)the overall load of the concerned pollutants discharged to thewater body is not increased compared to the situation where
the emissions from the installation concerned remainedcompliant 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 therequirements of the legislation mentioned above, these stricter
conditions apply.
2. Soil and groundwater protection:
Appropriate measures are in place to prevent emissions to soil andregular 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 14046:201419 and ensure that they do notcontribute 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 thisAnnex
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 theCommission Decision (EU) 2017/8489 in relation to the relevant
criteria and methodological standards for those descriptors.
(4) Transition to a The activity assesses the availability of and, where feasible, adopts

19

EN

ISO 14046:2014 Environmental management — Water footprint — Principles, requirements andguidelines, available at: https://www.iso.org/standard/43263.html.

7ENcircular economy

techniques that support:(a)reuse and use of secondary raw materials and reusedcomponents in products manufactured;(b)design for high durability, recyclability, easy disassembly andadaptability of products manufactured;(c)waste management that prioritises recycling over disposal, inthe manufacturing process;(d)

information on product ingredients along the supply chain.

(6) Protection and The activity complies with the criteria set out in Appendix D to thisrestorationof Annex.
biodiversity
andecosystems

1.2.

Manufacture of pharmaceutical products

Description of the activity
Manufacture of pharmaceutical products (drug products), including operations of receipt ofmaterials, production, packaging, repackaging, labelling, relabelling, quality control, release,storage, and distribution of APIs and related controls.
The economic activities in this category could be associated with NACE code C21.2 inaccordance with the statistical classification of economic activities established by Regulation(EC) No 1893/2006.
Technical screening criteria
Substantial contribution to pollution prevention and control
1. The activity complies with one of the following sets of requirements set out in point 1.1. or
1.2. relating to product substitution. In any case, the activity complies with the requirements
set out in point 1.3.
1.1. The pharmaceutical preparation complies with the following requirements set out inpoints 1.1.1. and 1.1.2.:
1.1.1. The pharmaceutical preparation complies with one of the following requirements:(a)EN

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

8ENAgency Guideline on the environmental risk assessment of medicinal products forhuman use (EMA ERA guideline)20, are generally considered to be degradable in theenvironment21;(b)

where the ingredients that constitute the formulation of the pharmaceuticalpreparation do not comply with the requirements specified in point (a), thoseingredients, their key human metabolites and their key transformation products in theenvironment 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 Biodegradability22, in accordance with the pass value for readybiodegradability 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 ofOECD Guidelines for the Testing of Chemicals24 compared to persistence
criteria as defined in the EMA ERA guideline.

1.1.2. The pharmaceutical preparation qualifies as an appropriate substitute to anotherpharmaceutical 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 inpoint 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

20

21

22

23

24

EN

European Medicines Agency Guidelines on the environmental risk assessment of medicinal products
for human use, available at https://www.ema.europa.eu/en/environmental-risk-assessment-medicinalproducts-human-use-scientific-guideline.
Key metabolites are human metabolites likely to be excreted into the environment. Those metabolites
are identified in (non-)clinical studies on the metabolism of pharmaceuticals available in the marketing
authorization applications. Such metabolites are to be identified according to
EMA/CPMP/ICH/286/1995, page 8. Key transformation products (TP) of these key human metabolitesof the parent compound (API) are those that exceed 10% of Dissolved Organic Carbon (DOC) or Total
Organic Carbon (TOC) of the parent compound.
OECD Guidelines for the Testing of Chemicals, Test 301 (A-F), Ready Biodegradability, available athttps://www.oecd.org/chemicalsafety/risk-assessment/1948209.pdf. OECD 301 (A-F) test is used to
identify substances which are assumed to rapidly and ultimately biodegrade, i.e., mineralised underaerobic environmental conditions).
Higher-tier studies (OECD 308) result with so-called half-lives indicating the time after which 50 %biodegradation of the API is achieved. Half-lives acceptable to demonstrate sufficiently quick
biodegradation, i.e., non-persistence, according to the Regulation (EC) No 1907/2006, Annex XIII,
which is also referenced in the EMA ERA guideline, apply.
OECD Guidelines for the Testing of Chemicals, Test No. 308: Aerobic and Anaerobic Transformationin Aquatic Sediment Systems, available at: https://www.oecd-ilibrary.org/environment/test-no-308aerobic-and-anaerobic-transformation-in-aquatic-sediment-systems_9789264070523-en.

9EN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 substanceobtained 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 theart, 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 thatanalysis.
1.2.6. The manufacturer contributes to mitigating the environmental impact of incorrect waste
disposal of unused pharmaceuticals, including by providing relevant information to thedownstream 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
conditions25.
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 ranges26 set out in:(a)the best available techniques (BAT) conclusions for common waste gas management
and treatment systems in the chemical sector27 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 ofOrganic Fine Chemicals (OFC)28; for the manufacturing activity under conditions notcovered by the BATC mentioned above;

25

The Commission will review the exceptions from the prohibition from manufacturing, placing on themarket or use of the substances referred to in points (f) and (g) once it will have published horizontal
principles on essential use of chemicals.
The requirements under this point tackle the pollutants identified under the key environmental issues ofeach BREF document or the BAT-AEL of the relevant BAT conclusions Commission Implementing
Decisions. Where BAT-AEL differentiate between “existing” and “new plants”, operators demonstratecompliance with BAT-AEL for new plants. When there is not a BAT-AEL range but a single value,emission levels are below such value. When the BAT-AEL range is expressed as follows: “<x-y unit”(I.e the lower-end BAT-AEL of the range is expressed as ‘lower than’), the mid-point is calculatedusing x and y. Averaging periods are the same as in the BAT-AEL of the BREF documents outlined
above.
Implementing Decision (EU) 2022/2427.
The Best Available Techniques Reference Document (BREF) for Manufacture of Organic Fine
Chemicals, available at https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/ofc_bref_0806.pdf.

26

27
28

EN

10

EN

(d)

the best available techniques (BAT) conclusions for common waste water and waste
gas treatment/management systems in the chemical sector29;(e)

the Best Available Techniques Reference Document (BREF) for the Large Volume
Inorganic Chemicals – Solids and Others industry30;(f)

the Best Available Techniques Reference Document (BREF) for the manufacture of
Large Volume Inorganic Chemicals - Ammonia, Acids and Fertilisers31;(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, theoperator applies Continuous Emission Monitoring Systems (CEMS), Continuous Effluent
Quality Monitoring Systems (CEQMS) and other measures ensuring the regular verificationof 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 solvents33 are avoided in pharmaceuticalproducts.
The maximum solvents loss from total inputs does not exceed a 3% loss. Total volatileorganic 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

29
30

31

32

33

EN

Implementing Decision (EU) 2016/902.
Best Available Techniques (BAT) Reference Document for the Large Volumes Inorganic ChemicalsSolids
and
Othersindustry,(versionof[adoptiondate]:
https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic-s_bref_0907.pdf).
Best Available Techniques (BAT) Reference Document for the manufacture of Large Volume Inorganic
Chemicals
Ammonia,
Acids
andFertilisers(versionof[adoptiondate]:
https://eippcb.jrc.ec.europa.eu/sites/default/files/2019-11/lvic_aaf.pdf).
The Best Available Techniques Reference Document (BREF) for the production of speciality inorganic
chemicals (SIC), available at https://eippcb.jrc.ec.europa.eu/reference/production-speciality-inorganicchemicals.
European Medicines Agency ICH guideline Q3C (R8) on impurities: guideline for residual solvents.
Step 5, 2022, available at . https://www.ema.europa.eu/en/documents/scientific-guideline/internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf.

11EN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 withtracer correlation (TC) or with optical absorption-based techniques, such as differential
absorption light detection and ranging (DIAL) or solar occultation flux (SOX) or measures ofother equivalent performance.
Diffuse emissions of substances or mixtures classified as CMR1A or 1B from leaky
equipment do not exceed a concentration of 100 ppmv34.
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 thanthose 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 frommanufacturing) 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 thesesubstances and their residues to non-hazardous waste materials are available at the facility andkept up to date.
Do no significant harm (‘DNSH’)

Where the activity involves on-site generation of heat/cool or cogeneration including power, the direct GHG emissions of the activity
are lower than 270 gCO2e/kWh.
For the refrigerant threshold, the Global Warming Potential does notexceed 150 in cooling of the substance.
(1) Climate change
Where pharmaceutical products
are made from substances listed in
mitigation
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 intheir 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

34

EN

Where the exemption under criterion 1.3 applies.

12

ENRecommendation 2013/179/EU or, alternatively, using ISO
14067:201835 or ISO 14064-1:201836. Quantified life-cycle GHG
emissions are verified by an independent third party.

(2) Climate change The activity complies with the criteria set out in Appendix A to thisadaptation
Annex.
(3) Sustainable use
and protection ofwater 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 ofwater 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 and2011/92/EU.
The activity implements best practices specified in the Joint ResearchCentre Best Environmental Management Practice for the Public
Administration Sector37.
Where wastewater treatment is conducted by an urban wastewater
treatment plant on behalf of the manufacturing plant, it is ensured that:

35

36

37

EN

(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 riskor harm to the health of the staff working in waste water
treatment plants;(c)the urban waste water treatment plant is designed andequipped appropriately to abate the released polluting
substances;(d)the overall load of the concerned pollutants discharged to thewater body is not increased compared to the situation where
the emissions from the installation concerned remainedcompliant with emission limit values set for direct releases;

ISO standard 14067:2018, Greenhouse gases — Carbon footprint of products — Requirements andguidelines for quantification, available at: https://www.iso.org/standard/71206.html.
ISO standard 14064-1:2018, Greenhouse gases — Part 1: Specification with guidance at theorganization level for quantification and reporting of greenhouse gas emissions and removals, available
at: https://www.iso.org/standard/66453.html.
Joint Research Centre, Best Environmental Management Practice for the Public Administration Sector,
2019, available at https://op.europa.eu/en/publication-detail/-/publication/6063f857-7789-11e9-9f0501aa75ed71a1/language-en.

13

EN

(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 therequirements of the legislation mentioned above, these stricter
conditions apply.
2. Soil and groundwater protection:
Appropriate measures are in place to prevent emissions to soil andregular 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 14046:201438 and ensure that they do notcontribute 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 thisAnnex
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 theCommission Decision (EU) 2017/8489 in relation to the relevant
criteria and methodological standards for those descriptors.

(4) Transition to a The activity assesses the availability of and, where feasible, adopts
circular economy
techniques that support:

38

EN

(a)

reuse and use of secondary raw materials and reusedcomponents in products manufactured;(b)design for high durability, recyclability, easy disassembly andadaptability of products manufactured;(c)waste management that prioritises recycling over disposal, in

ISO 14046:2014 Environmental management — Water footprint — Principles, requirements andguidelines, available at: https://www.iso.org/standard/43263.html.

14

ENthe manufacturing process;(d)

information on product ingredients along the supply chain.

(6) Protection and The activity complies with the criteria set out in Appendix D to thisrestorationof Annex.
biodiversity
andecosystems

2.

WATER SUPPLY, SEWERAGE, WASTE MANAGEMENT AND REMEDIATION ACTIVITIES

2.1.

Collection and transport of hazardous waste

Description of the activity
Separate collection and transport of hazardous waste39 prior to treatment, material recovery or
disposal, including the construction, operation and upgrade of facilities involved in thecollection and transport of such waste.
The economic activities in this category could be associated with several NACE codes, inparticular E38.12 and F42.9 in accordance with the statistical classification of economic
activities established by Regulation (EC) No 1893/2006.
Technical screening criteria
Substantial contribution to pollution prevention and control
1. Hazardous waste is source segregated and collected separately from non-hazardous waste
to prevent cross-contamination. Appropriate measures are taken to ensure that during separate
collection and transport, hazardous waste is not mixed nor diluted either with other categoriesof 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 standards41.

39

40
41

EN

Hazardous waste is waste which displays one or more of the hazardous properties listed in Annex III of
Directive 2008/98/EC. It includes streams such as hazardous waste fractions produced by households,
waste oils, batteries, non-depolluted waste from electrical and electronic equipment (WEEE), nondepolluted end-of-life vehicle, medical waste, etc. A comprehensive classification of hazardous waste
can be found in the European List of Waste (established by Commission Decision 2000/532/EC).
Available at https://unece.org/transportdangerous-goods/adr-2021-files.
In accordance with Regulation (EU) 2018/858.

15EN5. During collection and transport, hazardous waste is packaged and labelled in accordancewith 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 oftransport 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 arecollected separately;(b)collection and transport preserve the integrity of WEEE and prevent the leakage ofhazardous substances such as ozone-depleting substances, fluorinated greenhousegases 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 506251:201442and CLC/TS 50625-4:201743 or with regulatory requirements that are equivalent tothose set in CLC/EN 50625-1 and CLC/TS 50625-4 is a proof of compliance with therequirement that the collection and transport preserve the integrity of WEEE and batteries andprevents the leakage of hazardous substances.
Do no significant harm (‘DNSH’)(1) Climate change
N/A
mitigation(2) Climate change The activity complies with the criteria set out in Appendix A to thisadaptation
Annex.
(3) Sustainable use
The activity complies with the criteria set out in Appendix B to thisand protection ofAnnex.
water and marine
resources
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
42

43

EN

CLC/EN 50625-1: 2014 Collection, logistics & Treatment requirements for WEEE - Part 1: Generaltreatment requirements.
Collection, logistics & treatment requirements for WEEE -- Part 4: Specification for the collection andlogistics associated with WEEE.

16

EN

Commission Decision (EU) 2017/8489 in relation to the relevant
criteria and methodological standards for those descriptors.

(4) Transition to a Separately collected waste is not mixed in waste storage and transfer
circular economy
facilities with other waste or materials with different properties.
Recyclable waste is not disposed of, incinerated or co-incinerated.
(6) Protection and The activity complies with the criteria set out in Appendix D to thisrestorationof Annex.
biodiversity
andecosystems
2.2.

Treatment of hazardous waste

Description of the activity
Construction, repurposing, upgrade, and operation of dedicated facilities for the treatment of
hazardous waste, including the incineration of non-recyclable hazardous waste (operations
D10), biological treatment of hazardous waste (operations D8) and physico-chemicaltreatment (operations D9)44.
The activity does not include:(a)disposal operations (as set out in Annex I to the Directive 2008/98/EC) of hazardous
waste such as landfilling or permanent storage.

(b)

incineration of recyclable hazardous waste and incineration of non-hazardous waste;(c)treatment and disposal of toxic live or dead animals and other contaminated waste;(d)treatment and disposal of radioactive nuclear waste.

The economic activities in this category could be associated with several NACE codes, inparticular E38.22 in accordance with the statistical classification of economic activities
established by Regulation (EC) No 1893/2006.
Technical screening criteria
Substantial contribution to pollution prevention and control

44EN

As set out in Annex I to Directive 2008/98/EC.

17EN

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 treatment45 or the best
available techniques (BAT) conclusions for waste incineration46.
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 andthe 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 anddocumented analytical standard operating procedures;(b)documented sampling procedure consistent with relevant standards, such as EN
14899:200547;(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 theirprofession or experience, to deal with all necessary questions relevant for the treatment of thewastes in the waste treatment facility. The procedures are intended to pre-accepting andaccepting wastes at the waste treatment plant only if a suitable treatment route is available andthe 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 morehazardous 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 theadequate treatment of the waste.
2. For the physico-chemical treatment of solid or pasty waste, any treatment for the purpose oftreating waste prior to final disposal, such as in hazardous waste landfills, is designed to fullfil
45
46

47

EN

Implementing Decision (EU) 2018/1147.
Commission Implementing Decision (EU) 2019/2010 of 12 November 2019 establishing the best
available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament andof the Council, for waste incineration (OJ L 312, 3.12.2019, p. 55).
EN 14899:2005 Characterization of waste - Sampling of waste materials - Framework for the
preparation and application of a Sampling Plan.

18

EN

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 theoutput waste after a leaching test with L/S = 10 l/kg based on EU Standard EN
12457-2:200248.

3. For the physico-chemical treatment of waste with calorific value, measures are taken inorder 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. Anytreatment 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 otherrelated 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 988849 (Zahn Wellens), or other commonly
accepted, equivalent industry standards and methodologies used to assess bio-elimination andrelated 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 caseof transboundary movement, requirements of Chapter I of the Regulation (EC) No 1013/2006of the European Parliament and of the Council50 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 toRegulation (EU) 2019/1021;(b)

the effective destruction or irreversible transformation of the POP waste in48

EN 12457-2:2002 Characterisation of waste - Leaching - Compliance test for leaching of granular wastematerials and sludges - Part 2: One stage batch test at a liquid to solid ratio of 10 l/kg for materials withparticle size below 4 mm (without or with size reduction).
EN ISO 9888:1999 Water quality — Evaluation of ultimate aerobic biodegradability of organic
compounds in aqueous medium — Static test (Zahn-Wellens method), available at:https://www.iso.org/standard/28121.html.
Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on
shipments of waste (OJ L 190, 12.7.2006, p. 1).

49

50

EN

19

EN

compliance with Articles 7(2) – 7(4) and Annex V to Regulation (EU) 2019/1021.
6. For the treatment of mercury-containing waste51, all installations likely to treat wasteconsisting 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 thebest practices set out in the WHO handbook on safe management of wastes from health-care
activities52.
A non-combustion healthcare waste installation has specific acceptance procedure, monitorsand 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
N/A
mitigation(2) Climate change The activity complies with the criteria set out in Appendix A to thisadaptation
Annex.

The activity complies with the criteria set out in Appendix B to thisAnnex.
(3) Sustainable use
and protection of Relevant techniques are deployed for the protection of water andwater and marine marine resources, as set out in53 the best available techniques (BAT)
conclusions for waste treatment .
resources
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)
51

52

53

EN

Mercury-containing waste means waste consisting of, containing or contaminated with mercury or
mercury compounds.
WHO, Safe management of wastes from health-care activities, 2nd edition, 2014, available athttps://www.euro.who.int/__data/assets/pdf_file/0012/268779/Safe-management-of-wastes-fromhealth-care-activities-Eng.pdf.
Implementing Decision (EU) 2018/1147.

20

EN

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 theCommission Decision (EU) 2017/8489 in relation to the relevant
criteria and methodological standards for those descriptors.

(4) Transition to a
N/Acircular economy(6) Protection and
The activity complies with the criteria set out in Appendix D to thisrestorationofAnnex.
biodiversity
andecosystems
2.3.

Remediation of legally non-conforming landfills and abandoned or illegal waste
dumps

Description of the activity
Remediation of legally non-conforming landfills54 and of abandoned or illegal waste dumps55.
The activity may include any of the following remediation strategies and sub-activities
typically implemented as part of projects aimed at removing, controlling, containing or
diminishing polluting emissions56 from non-conforming landfills and abandoned or illegal
dumpsites:
(a)

54

55

56

EN

remediation through environmental isolation of non-conforming or illegal landfills or
dumpsites at the present site, including:(i)

physical isolation, concentration, structural stabilisation and protection of the
non-conforming or illegal landfill or dumpsite, including application of
hydraulic barriers, sealing, drainage and cover layers;(ii)

installation, operation and maintenance of drainage and separate collection andtreatment systems for leachates and run-off water prior to discharge;

The term ‘landfill’ is defined in Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste(OJ L 182, 16.7.1999, p. 1) as a “waste disposal site for the deposit of the waste onto or into land (i.e.,underground)” including both non-hazardous and hazardous waste.
A ‘legally non-conforming’ landfill is a landfill that does not comply with the operational and technicalrequirements defined in relevant EU or national legislation.
A ‘waste dump’ is a site used for the disposal of waste that is not equipped with pollution abatement
systems.
‘Emission’ means the release in the environment, as a result of human activities, of substances,
preparations, organisms or micro-organisms (as set out in Article 2 of Directive 2004/35/CE of theEuropean Parliament and of the Council of 21 April 2004 on environmental liability with regard to theprevention and remedying of environmental damage (OJ L 143, 30.4.2004, p. 56).

21

EN

(iii) installation, operation and maintenance of landfill gas collection, abatement
and control systems, including wells, piping and flaring systems;(iv) application of top soil and vegetation cover for renaturation purposes;
(b)

(c)

remediation through excavation and removal of non-conforming or illegal landfills or
dumpsites with subsequent treatment, recovery or disposal of excavated waste,
including:(i)selective excavation of the waste deposited on the site, loading and transport toexisting permitted treatment, recovery or disposal facilities with separate
management of non-hazardous and hazardous waste;(ii)

sorting and recovery of materials and fuels from excavated non-hazardous
waste, including the installation, operation and maintenance of dedicatedfacilities and equipment for the duration of the remediation project;

remediation through decontamination of soils, surface and groundwater at the placeof pollution, including the following:(i)selective excavation, loading, transport, temporary storage, backfilling of soil,
with separate management of non-contaminated and contaminated soils;(ii)

treatment of contaminated soil or water, either in situ or ex situ, using inparticular mechanical, chemical or biological methods, including the
installation, operation and maintenance of dedicated facilities for the durationof the remediation project;(iii) application of hydraulic barriers, active and passive barriers intended tolimit/prevent migration of pollutants.
The activity also includes all of the following sub-activities that are required to prepare, plan,
monitor and follow-up on the above remediation measures:(a)

preparatory investigations, including data collection and surveying activities (inparticular geological or hydrological), technical feasibility and environmental impact
studies required to define the remediation project;(b)site preparation, including earth moving and levelling works, construction or
reinforcement of perimeter walls or fences, primary access and internal roads,
demolition of buildings or other structures on the landfill site;(c)monitoring and control of the remediation measures, including:(i)sampling of soil, water, sediment, biota or other materials;(ii)

laboratory analysis of samples to identify the nature and concentration ofpollutants;(iii) installation, operation and maintenance of monitoring facilities and equipment
such as observation wells in and outside the perimeter of the landfill site;(d)implementation of other environmental protection and pollution prevention andcontrol measures to comply with the conditions imposed in the environmental permit
for the remediation project, including measures for safeguarding safety of operations
on-site and health of workers, such as for fire control, flood protection, hazardous
waste management.

The activity does not include:

EN

22

EN

(a)

the permanent closure, rehabilitation and after care of existing or new landfills thatcomply with the Council Directive 1999/31/EC57, or for activities located in third
countries having equivalent national legislation or otherwise aligned with recognizedinternational industry standards58;(b)

landfill gas transformation for utilization as energy carrier or industry feedstock;(c)

redevelopment of the remediated site for other economic use such as recreational,
residential or commercial areas, installation of photovoltaic (PV) panels;(d)compensatory measures for pollution caused by the landfill or dumpsite such as thedevelopment and operation of alternative water supply systems for affected
population living in the surrounding area.

The economic activities in this category could be associated with several NACE codes, inparticular E39, E38.2, E38.32 and F42.9 in accordance with the statistical classification of
economic activities established by Regulation (EC) No 1893/2006.
Technical screening criteria
Substantial contribution to pollution prevention and control
1. The activity complies with all of the following criteria:(a)the remediation activity is not undertaken by the operator59 that caused the pollution
or a producer of waste or a person acting on behalf of that operator or producer inorder to comply with the Directive 2004/35/CE of the European Parliament and of
the Council60 or, for activities located in third countries, with an equivalent national
legislation or international standards that apply the polluter-pays-principle to theremediation of environmental pollution caused by economic activities;(b)

relevant contaminants are removed, controlled, contained or diminished using
mechanical, chemical, biological or other methods to ensure that the landfill and thecontaminated area (land, water body or other), taking into account its use at the timeof the damage or approved future use of the area, no longer pose any significant riskof adversely affecting human health and the environment, as specified in national
regulatory standards or, where such standards are not available, in an internal riskassessment taking into account the characteristic and the extent of the impacted area
(land, water body or other), the type, properties (persistence, mobility and toxicity)and concentration of the substances, preparations, organisms or micro-organisms,
possible migration pathways and the probability of dispersion61.

2. The activity is prepared and conducted in line with best industry practice and includes all of
57
58

59
60

61

EN

Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste, OJ L 182, 16.7.1999, p. 1.
Such as, at the international level, landfill operational guidelines published by the International Solid
Waste Association (ISWA).
As defined in Article 2, point 6, of Directive 2004/35/CE.
Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on
environmental liability with regard to the prevention and remedying of environmental damage (OJ L
143, 30.04.2004, p. 56).
See Directive 2004/35/CE , Annex II, point 2. For remediation activities outside the EU, unless equal ormore stringent standards are mandatory under national legislation, reference is made to the UNEP
Guidance on the management of contaminated sites.

23

ENthe following elements:(a)the non-conforming or illegal landfill or dumpsite to be remediated has been closed
and is not taking in further waste other than possibly inert or biostabilized waste to
be used as landfill cover material (as far as allowed in the environmental permit for
the remediation project);(b)

preparatory investigations including site-specific surveys and physical, chemical or
microbiological data collection are carried out in line with best industry practice andbest available techniques to establish:(i)the location, characteristics and extension of the landfill and the polluted area;(ii)

the underlying geological and hydrological conditions;(iii) the likely quantity, composition and sources of the landfilled waste;(iv) soil and water pollution originating from it as well as the risks to human healthand the environment.

EN

(c)

the results of such remedial investigations are inputs for a feasibility study thatdefines the objectives, targets and scope for the remediation and evaluates alternative
remedial options;(d)the remedial options are analysed in accordance with the requirements set out inAnnex II to Directive 2004/35/CE and in Annexes I and III to Directive 1999/31/EC,
or for activities located in third countries in equivalent national law or commonly
accepted international standards62, and described in a feasibility study produced forthe landfill remediation project that convincingly demonstrates how the selected
remedial option is the overall best solution to meet the defined remediation
objectives and targets;(e)the landfill remediation project, including accompanying monitoring and control
plan, is approved by the competent authority and consulted on with local
stakeholders in accordance with national legal requirements;(f)

all materials and fuels recovered from landfilled waste meet relevant quality
standards or user specifications for the intended recovery operations and do not
represent a risk for the environment or human health;(g)

any hazardous waste extracted or otherwise produced by the remediation activity is
subject to appropriate collection, transport, treatment, recovery or disposal by anauthorized operator, in accordance with national legal requirements;(h)soil and groundwater remediation methods based exclusively on reducing pollutant
concentrations through dilution or watering down are not used;(i)a control and monitoring plan is implemented, including measures to control theimpacts of the remediation activities and to verify the achievement of theremediation objectives and targets, for at least 10 years in case of excavation andremoval of the landfill or dumpsite and for at least 30 years in case of environmental

62

See Directive 2004/35/CE, Annex II, point 1.3.1. For remediation activities outside the EU, reference ismade to the UNEP Guidance on the management of contaminated sites and the standards and guidance
documents for landfill management published by the International Solid Waste Association, includingInternational Guidelines for Landfill Evaluation (2011), Roadmap for Closing Waste Dumpsites (2016)
and Landfill Operational Guidelines (2014, 2019).

24

ENisolation of the landfill or dumpsite, unless a different duration sufficient toguarantee long-term risk control is defined in national legislation or by the competentregulatory authority for the specific remediation project.
Do no significant harm (‘DNSH’)

Where the landfill body contains significant amounts of biodegradable
waste, a system for landfill gas capture and abatement and a monitoring(1) Climate change plan for landfill gas leakage is in place in accordance with operational
mitigationand technical requirements of Directive 1999/31/EC, or for activities
located in third countries in accordance with equivalent national law orcommonly accepted international industry standards63.

(2) Climate change The activity complies with the criteria set out in Appendix A to thisadaptation
Annex.
(3) Sustainable use
The activity complies with the criteria set out in Appendix B to thisand protection ofAnnex.
water and marine
resources
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 theCommission Decision (EU) 2017/8489 in relation to the relevant
criteria and methodological standards for those descriptors.
Remedial measures are protective of water and marine resources andapply best industry practices and technology64 with the aim of:
(a)

63

64

EN

reducing the generation of leachates from the landfill andavoiding outflow or infiltration of leachates into the

For remediation activities outside the EU, reference is made to the UNEP Guidance on the managementof contaminated sites and the standards and guidance documents for landfill managament published by
the International Solid Waste Association, including International Guidelines for Landfill Evaluation(2011), Roadmap for Closing Waste Dumpsites (2016) and Landfill Operational Guidelines (2014,2019).
For remediation activities outside the EU, reference is made to the UNEP Guidance on the managementof contaminated sites and the standards and guidance documents for landfill managament published by
the International Solid Waste Association, including International Guidelines for Landfill Evaluation(2011), Roadmap for Closing Waste Dumpsites (2016) and Landfill Operational Guidelines (2014,2019).

25

ENsurrounding soil and any potential hazard to groundwater andsurface water;(b)

separately collecting and appropriately treating run-off waterand leachates before discharge;(c)

tracking and analysing leachate generation rates and leachate
concentration and composition in the after-care period throughappropriate control and monitoring systems and processes;(d)separately collecting and appropriately treating polluted soil inand around the landfill in order to block the pathway from thelandfill to waterbodies through heavily soaked soil.

(4) Transition to a Where the remediation project foresees the excavation and removal of
circular economy
the existing landfill or dumpsite, the excavated waste is managed inaccordance with the waste hierarchy principle, prioritizing recycling
over other types of material recovery, over incineration and disposal, tothe extent that this is technically feasible and does not increase risks forthe environmental or human health.
(6) Protection andrestorationof
biodiversity
andecosystems

2.4.

The activity complies with the criteria set out in Appendix D to thisAnnex.
Where applicable, the introduction of invasive alien species isprevented or their spread is managed in accordance with Regulation(EU) No 1143/2014.

Remediation of contaminated sites and areas

Description of the activity
The activity includes:(a)decontamination or remediation of soils and groundwater in the polluted area, either
in situ or ex situ, in particular using mechanical, physical, chemical or biologicalmethods;(b)

decontamination or remediation of contaminated industrial plants or sites;(c)decontamination or remediation of surface water and its shores following accidental
pollution, such as through collection of pollutants or through physical, chemical or
biological methods;(d)cleaning up oil spills and other types of pollutants on or in:(i)surface water including rivers, lakes, coastal waters or transitional waters;(i)groundwater as defined in Directive 2000/60/EC;(ii)

marine water as defined in Directive 2008/56/EC;(iii) sediments (for all surface water types);(iv) aquatic ecosystems;

EN

26

EN

(v)

buildings;(vi) soil;(vii) terrestrial ecosystems ;(e)material abatement of hazardous substances, mixtures or products, such as asbestos
or lead-based paint;(f)other specialised pollution-control activities;(g)clean-up after disasters from natural hazards, such as flooding, or earthquake;(h)remediation of disused mining sites or legacies not associated with extraction
revenues;(i)containment operations, hydraulic barriers, active and passive barriers intended tolimit or prevent migration of pollutants.

The activity also includes all activities that are required to prepare, plan, monitor and followup the decontamination or remediation activity itself, such as:(a)preparatory investigations, including data collection and surveying activities (inparticular geological or hydrological), technical feasibility and environmental impact
studies required to define the remediation project;(b)monitoring and control of the remediation measures, including:(i)sampling of soil, water, sediment, biota or other materials;(ii)

laboratory analysis of samples to identify the nature and concentration ofpollutants;(iii) installation, operation and maintenance of monitoring facilities and equipment
such as observation wells in and outside the perimeter of the remediation site;(c)demolition of contaminated buildings or other structures, dismantling large-scalemachinery and equipment (i.e., decommissioning) and removal of surface sealing
and concreting;(d)earth moving or dredging, including excavation, landfilling, levelling, construction or
reinforcement of perimeter walls or fences, primary access and internal roads andany other activities necessary to operate the decontamination;(e)

implementation of other environmental protection and pollution prevention andcontrol measures to comply with the conditions imposed in the environmental permit
for the remediation project, including measures for safeguarding safety of operations
on-site and health of workers (such as for fire control, flood protection, hazardous
waste management), protection of workers, site access control, management ofinvasive species before or during decontamination or remediation, reinforcement
operations carried out prior to or during decontamination.

This economic activity does not include:

EN

(a)

pest control in agriculture;(b)

purification of water for water supply purposes;(c)decontamination or remediation of nuclear plants and sites;(d)treatment and disposal of hazardous or non-hazardous waste unrelated to the site
contamination problem;

27

EN

(e)

morphological remediation;(f)remediation of legally non-conforming landfills and abandoned or illegal waste
dumps unrelated to the site under remediation (See Section 2.3. of this Annex);(g)

emergency services (see Section 14.1. of Annex II to Delegated Regulation (EU)2021/2139);(h)outdoor sweeping and watering of streets.

The economic activities in this category could be associated with several NACE codes, inparticular 39, 33.20, 43.11, 43.12, 71.12, 71.20, 74.90, 81.30 in accordance with the statisticalclassification of economic activities established by Regulation (EC) No 1893/2006.
Technical screening criteria
Substantial contribution to pollution prevention and control
1. Remediation activities are not carried out by the operator65 that caused the pollution or aperson acting on behalf of that operator in order to comply with the requirements of Directive
2004/35/CE or, for activities located in third countries, with environmental liability provisions
based on the ‘polluter-pays’ principle according to national law.
2. The relevant contaminants are removed, controlled, contained or diminished using
mechanical, chemical, biological or other methods so that the contaminated area (land, water
body or other), taking into account its use at the time of the damage or approved future use of
the area, no longer poses any significant risk of adversely affecting human health and theenvironment66, as set out in one of the following:(a)national regulatory standards;(b)

where these standards are not available, an internal site-specific risk-assessment
taking into account the characteristic and the extent of the impacted area (land, water
body or other), the type, properties (persistence, mobility and toxicity) andconcentration of the substances, preparations, organisms or micro- organisms,
possible migration pathways and the probability of dispersion67.

3. The remediation activity is conducted in line with best industry practice and includes all of
the following elements:(a)the original activity that led to the contamination has stopped and is no longer asource of potential further contamination before any assessment or remediation
activity is undertaken (except long-range transboundary air pollution or otherunidentifiable diffuse sources);

65

As defined in Article 2, point 6, of, Directive 2004/35/CE.
See Directive 2004/35/CE , Annex II, point 2.
See Directive 2004/35/CE , Annex II, point 2. For activities in third countries, unless more stringent
standards are mandatory under national legislation, UNEP Guidance on the management ofcontaminatedsites(UNEP/MC/COP.3/8/Rev.1)
Guidance_Contaminated_Sites_EN.pdf(mercuryconvention.org) are applied.

66
67

EN

28

EN

(b)

preparatory investigations including site-specific surveys and physical, chemical or
microbiological data collection are carried out in line with best industry practice andbest available techniques to establish the following elements used to define theenvironmental targets for the remediation and evaluate the remedial options:(i)the location, characteristics and extension of the contaminated site;(ii)

the underlying geological and hydrological conditions;(iii) the likely quantity, composition and sources of contamination;(iv) soil and water pollution originating from it as well as the risks to human healthand the environment.
(c)the remedial options are analysed in line with Annex II to Directive 2004/35/CE68
and the most suitable remedial measures are defined in a dedicated remediation plan,
including monitoring requirements and plan;(d)any hazardous or non-hazardous waste extracted or otherwise produced by theremediation activity is subject to appropriate collection, transport, treatment,
recovery or disposal by an authorized operator, in accordance with legal
requirements;(e)

remediation methods do not include reducing pollutant concentrations throughdilution or watering down, unless a full justification, for reason other than costconsiderations, is provided in the remediation plan;(f)control, monitoring or maintenance activities are carried out in the after-care phase ofat least 10 years, unless a different duration sufficient to guarantee long-term risk
control is defined in the national law or in the remediation and monitoring plan (seepoint 4).

4. The specific remediation and monitoring plan is approved by the competent authority inaccordance with national legal requirements, following consultation with local stakeholders.
Do no significant harm (‘DNSH’)

The activity does not involve the degradation of land with high carbon(1) Climate change
stock69.
mitigation
Measures to reduce scope 1 and scope 2 GHG emissions70 of the full

68

69

EN

See Directive 2004/35/CE, Annex II, point 1.3.1.
For activities in third countries, in accordance with equivalent applicable national law or international
standards (such as UNEP Guidance on the management of contaminated sites(UNEP/MC/COP.3/8/Rev.1) -Guidance_Contaminated_Sites_EN.pdf (mercuryconvention.org) )requiring remediation based on an alternative, transparently described process and valuation approachto define a suitable strategy, which comprises primary remedial measures (including monitoring
requirements), complementary and compensatory remedial measures in a dedicated remediation plan.
Land with high-carbon stock means wetlands, including peatland, and continuously forested areas
grasslands, mangroves and seagrass meadows within the meaning of Article 29(4)(a), (b) and (c) of
Directive (EU) 2018/2001.

29

ENremoval or treatment process are included in the remediation plan.

(2) Climate change The activity complies with the criteria set out in Appendix A to thisadaptation
Annex.
(3) Sustainable use
The activity complies with the criteria set out in Appendix B to thisand protection ofAnnex.
water and marine
resources
Environmental degradation risks related to preserving marine
environment, in particular risk to the good environmental status asdefined in Directive 2008/56/EC, are identified and addressed.
The activity does not hamper the achievement of good environmental
status of marine waters or does not deteriorate marine waters that are
already in good environmental status as defined in 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 theCommission Decision (EU) 2017/8489 in relation to the relevant
criteria and methodological standards for those descriptors.

(4) Transition to a At least 70% (by weight) of the non-hazardous construction, demolition
circular economy
or other waste materials (excluding naturally occurring material definedin category 17 05 04 in the European List of Waste established by
Decision 2000/532/EC) generated on the site under remediation isprepared for reuse, recycling and other material recovery, including
backfilling operations using waste to substitute other materials, inaccordance with the waste hierarchy, unless a clear justification is givenin the approved Remediation Plan based on technical or environmental
reasons, other than cost considerations.
(6) Protection andrestorationof
biodiversity
andecosystems

70

EN

The activity complies with the criteria set out in Appendix D to thisAnnex.
In areas designated by the national competent authority forconservation, the activity is in accordance with the conservation‘Scope 1 GHG emissions’ means the direct greenhouse gas emissions occurring from sources that are
owned or controlled by the operator. ‘Scope 2 GHG emissions’ means the indirect greenhouse gas
emissions from the generation of the electricity consumed by the operator.

30

EN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.
Where applicable, the introduction of invasive alien species isprevented or their spread is managed in accordance with Regulation(EU) No 1143/2014.

EN

31

EN

APPENDIX A: GENERIC CRITERIA FOR DNSH TO CLIMATE CHANGE ADAPTATION
I. Criteria
The physical climate risks that are material to the activity have been identified from thoselisted in the table in Section II of this Appendix by performing a robust climate risk andvulnerability assessment with the following steps:(a)screening of the activity to identify which physical climate risks from the list in
Section II of this Appendix may affect the performance of the economic activity during its
expected lifetime;(b)where the activity is assessed to be at risk from one or more of the physical climate
risks listed in Section II of this Appendix, a climate risk and vulnerability assessment toassess the materiality of the physical climate risks on the economic activity;
(c)
risk.

an assessment of adaptation solutions that can reduce the identified physical climate

The climate risk and vulnerability assessment is proportionate to the scale of the activity andits expected lifespan, such that:(a)for activities with an expected lifespan of less than 10 years, the assessment isperformed, at least by using climate projections at the smallest appropriate scale;(b)
for all other activities, the assessment is performed using the highest available
resolution, state-of-the-art climate projections across the existing range of future scenarios71
consistent with the expected lifetime of the activity, including, at least, 10 to 30 year climate
projections scenarios for major investments.
The climate projections and assessment of impacts are based on best practice and available
guidance and take into account the state-of-the-art science for vulnerability and risk analysis
and related methodologies in line with the most recent Intergovernmental Panel on Climate
Change reports72, scientific peer-reviewed publications, and open source73 or paying models.
For existing activities and new activities using existing physical assets, the economic operator
implements physical and non-physical solutions (‘adaptation solutions’), over a period of timeof up to five years, that reduce the most important identified physical climate risks that arematerial to that activity. An adaptation plan for the implementation of those solutions is drawn
up accordingly.

71

72

73

EN

Future scenarios include Intergovernmental Panel on Climate Change representative concentration
pathways RCP2.6, RCP4.5, RCP6.0 and RCP8.5.
Assessments Reports on Climate Change: Impacts, Adaptation and Vulnerability, publishedperiodically by the Intergovernmental Panel on Climate Change (IPCC), the United Nations body forassessing the science related to climate change produces, https://www.ipcc.ch/reports/.
Such as Copernicus services managed by the European Commission.

32

ENFor new activities and existing activities using newly-built physical assets, the economic
operator integrates the adaptation solutions that reduce the most important identified physicalclimate risks that are material to that activity at the time of design and construction and has
implemented them before the start of operations.
The adaptation solutions implemented do not adversely affect the adaptation efforts or thelevel of resilience to physical climate risks of other people, of nature, of cultural heritage, ofassets and of other economic activities; are consistent with local, sectoral, regional or national
adaptation strategies and plans; and consider the use of nature-based solutions74 or rely on
blue or green infrastructure75 to the extent possible.
II. Classification of climate-related hazards76
Temperaturerelated

Wind-related

Chronic

Changing
Changing
temperature(air, patterns
freshwater, marine
water)

Water-related

Solid mass-related

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

Heat stress

Precipitationhydrologicalvariability

or Soil degradation

Temperature
variability

Ocean acidification

Soil erosion

Permafrost thawing

Saline intrusion

Solifluction

Sea level rise

Acute

Water stress

74

75

76

EN

Heat wave

Cyclone, hurricane, Drought
typhoonCold wave/frost

Storm (including Heavy precipitation Landslide
blizzards, dust and (rain,hail,sandstorms)
snow/ice)

Wildfire

TornadoFloodfluvial,Avalanche(coastal, Subsidence
pluvial,Nature-based solutions are defined as ‘solutions that are inspired and supported by nature, which arecost-effective, simultaneously provide environmental, social and economic benefits and help build
resilience. Such solutions bring more, and more diverse, nature and natural features and processes into
cities, landscapes and seascapes, through locally adapted, resource-efficient and systemic interventions’.
Therefore, nature-based solutions benefit biodiversity and support the delivery of a range of ecosystemservices.(version of [adoption date]: https://ec.europa.eu/research/environment/index.cfm?pg=nbs ).
See Communication from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions: Green Infrastructure (GI) —Enhancing Europe’s Natural Capital (COM/2013/0249 final).
The list of climate-related hazards in this table is non-exhaustive, and constitutes only an indicative listof most widespread hazards that are to be taken into account as a minimum in the climate risk andvulnerability assessment.

33

ENground water)
Glacialoutburst

EN

34

lake

EN

APPENDIX B: GENERIC CRITERIA FOR DNSH TO SUSTAINABLE USE AND PROTECTION OF
WATER AND MARINE RESOURCES

Environmental degradation risks related to preserving water quality and avoiding water stressare identified and addressed with the aim of achieving good water status and good ecologicalpotential as defined in Article 2, points (22) and (23), of Regulation (EU) 2020/852, in
accordance with Directive 2000/60/EC77 and a water use and protection management plan,developed thereunder for the potentially affected water body or bodies, in consultation with
relevant stakeholders.
Where an Environmental Impact Assessment is carried out in accordance with Directive
2011/92/EU and includes an assessment of the impact on water in accordance with Directive
2000/60/EC, no additional assessment of impact on water is required, provided the risks
identified have been addressed.

77

EN

For activities in third countries, in accordance with applicable national law or international standards
which pursue equivalent objectives of good water status and good ecological potential, throughequivalent procedural and substantive rules, i.e. a water use and protection management plan developedin consultation with relevant stakeholders which ensures that 1) the impact of the activities on theidentified status or ecological potential of potentially affected water body or bodies is assessed and 2)
deterioration or prevention of good status/ecological potential is avoided or, where this is not possible,
3) justified by the lack of better environmental alternatives which are not disproportionately
costly/technically unfeasible, and all practicable steps are taken to mitigate the adverse impact on thestatus of the body of water.

35

EN

APPENDIX D: GENERIC CRITERIA FOR DNSH TO PROTECTION AND RESTORATION OF
BIODIVERSITY AND ECOSYSTEMSAn Environmental Impact Assessment (EIA) or screening78 has been completed in accordancewith Directive 2011/92/EU79.
Where an EIA has been carried out, the required mitigation and compensation measures forprotecting the environment are implemented.
For sites/operations located in or near biodiversity-sensitive areas (including the Natura 2000
network of protected areas, UNESCO World Heritage sites and Key Biodiversity Areas, aswell as other protected areas), an appropriate assessment80, where applicable, has been
conducted and based on its conclusions the necessary mitigation measures81 are implemented.

78

79

80

81

EN

The procedure through which the competent authority determines whether projects listed in Annex II to
Directive 2011/92/EU is to be made subject to an environmental impact assessment (as referred to in
Article 4(2) of that Directive).
For activities in third countries, in accordance with equivalent applicable national law or international
standards requiring the completion of an EIA or screening, for example, IFC Performance Standard 1:
Assessment and Management of Environmental and Social Risks.
In accordance with Directives 2009/147/EC and 92/43/EEC. For activities located in third countries, inaccordance with equivalent applicable national law or international standards, that aim at theconservation of natural habitats, wild fauna and wild flora, and that require to carry out (1) a screening
procedure to determine whether, for a given activity, an appropriate assessment of the possible impacts
on protected habitats and species is needed; (2) such an appropriate assessment where the screening
determines that it is needed, for example IFC Performance Standard 6: Biodiversity Conservation andSustainable Management of Living Natural Resources.
Those measures have been identified to ensure that the project, plan or activity will not have any
significant effects on the conservation objectives of the protected area.

36

EN