# C_2020449EN.01021901.xml

| 23.12.2020 | EN | Official Journal of the European Union | C 449/219 |
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23.12.2020

EN

Official Journal of the European Union

C 449/219

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P8_TA(2019)0071

Minimum requirements for water reuse ***I

European Parliament legislative resolution of 12 February 2019 on the proposal for a regulation of the European Parliament and of the Council on minimum requirements for water reuse (COM(2018)0337 — C8-0220/2018 — 2018/0169(COD))

(Ordinary legislative procedure: first reading)

(2020/C 449/35)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2018)0337), |
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—

having regard to the Commission proposal to Parliament and the Council (COM(2018)0337),

| — | having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0220/2018), |
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—

having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0220/2018),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
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—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the opinion of the European Economic and Social Committee of 12 December 2018 (1), |
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—

having regard to the opinion of the European Economic and Social Committee of 12 December 2018 (1),

| — | having regard to the opinion of the Committee of the Regions of 6 December 2018 (2), |
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—

having regard to the opinion of the Committee of the Regions of 6 December 2018 (2),

| — | having regard to Rule 59 of its Rules of Procedure, |
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—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development (A8-0044/2019), |
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—

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development (A8-0044/2019),

| 1. | Adopts its position at first reading hereinafter set out; |
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1.

| 2. | Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal; |
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2.

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
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3.

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(1)  Not yet published in the Official Journal.

(2)  OJ C 86, 7.3.2019, p. 353.

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P8_TC1-COD(2018)0169

Position of the European Parliament adopted at first reading on 12 February 2019 with a view to the adoption of Regulation (EU) .../... of the European Parliament and of the Council on minimum requirements for water reuse

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,

Having regard to the proposal from the European Commission,

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

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

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

| (1) | The water resources of the Union are increasingly coming under pressure, leading to water scarcity and quality deterioration. In particular, climate change
  , unpredictable weather patterns
  and drought are contributing significantly to the strain on the availability of freshwater, arising from urban development and agriculture. [Am. 1] |
| --- | --- |

(1)

The water resources of the Union are increasingly coming under pressure, leading to water scarcity and quality deterioration. In particular, climate change
  , unpredictable weather patterns
  and drought are contributing significantly to the strain on the availability of freshwater, arising from urban development and agriculture. [Am. 1]

| (2) | The Union’s ability to respond to the increasing pressure

  pressures
  on water resources could be enhanced by wider reuse of treated waste water
  , limiting extraction from water bodies and groundwater, reducing the impact of discharge of treated waste water into water bodies, and promoting water savings through the multiple use of urban waste water, while ensuring a high level of environmental protection
  . Directive 2000/60/EC of the European Parliament and of the Council (4) mentions the

  water
  reuse, of water

  in combination with the promotion of the use of water-efficient technologies in industry and water-saving irrigation techniques,
  as one of the supplementary measures Member States may choose to apply to achieve the Directive’s objectives of good qualitative and quantitative water status for surface waters and groundwaters. Council Directive 91/271/EEC (5) requires that treated waste water be reused whenever appropriate. [Am. 2] |
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(2)

The Union’s ability to respond to the increasing pressure

  pressures
  on water resources could be enhanced by wider reuse of treated waste water
  , limiting extraction from water bodies and groundwater, reducing the impact of discharge of treated waste water into water bodies, and promoting water savings through the multiple use of urban waste water, while ensuring a high level of environmental protection
  . Directive 2000/60/EC of the European Parliament and of the Council (4) mentions the

  water
  reuse, of water

  in combination with the promotion of the use of water-efficient technologies in industry and water-saving irrigation techniques,
  as one of the supplementary measures Member States may choose to apply to achieve the Directive’s objectives of good qualitative and quantitative water status for surface waters and groundwaters. Council Directive 91/271/EEC (5) requires that treated waste water be reused whenever appropriate. [Am. 2]

| (2a) | A particular problem in many areas is the age and poor condition of treated waste water distribution infrastructure, which leads to a huge loss of that treated waste water and the attendant waste of the financial resources invested in that treatment. The upgrading of all such pipe infrastructure should thus be a priority. [Am. 3] |
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(2a)

A particular problem in many areas is the age and poor condition of treated waste water distribution infrastructure, which leads to a huge loss of that treated waste water and the attendant waste of the financial resources invested in that treatment. The upgrading of all such pipe infrastructure should thus be a priority. [Am. 3]

| (3) | The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on ‘A Blueprint to Safeguard Europe's Water Resources’ (6) pointed to water reuse for irrigation or industrial purposes as

  the need to create an instrument to regulate standards at Union level for water reuse, to remove the barriers to a widespread use of such
  an alternative water supply option requiring Union attention

  , namely one that can help to reduce water scarcity and lessen the vulnerability of supply systems
  . [Am. 4] |
| --- | --- |

(3)

The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on ‘A Blueprint to Safeguard Europe's Water Resources’ (6) pointed to water reuse for irrigation or industrial purposes as

  the need to create an instrument to regulate standards at Union level for water reuse, to remove the barriers to a widespread use of such
  an alternative water supply option requiring Union attention

  , namely one that can help to reduce water scarcity and lessen the vulnerability of supply systems
  . [Am. 4]

| (4) | The Communication from the Commission to the European Parliament and the Council ‘Addressing the challenge of water scarcity and droughts in the European Union’ (7) sets out the hierarchy of measures that Member States should consider in managing water scarcity and droughts.
  For the same purpose, it would be advisable to lay down within Directive 2000/60/EC a binding hierarchy of measures for the sound management of water
  . It states that in regions where all preventive measures have been implemented according to the water hierarchy and where demand for water still exceeds availability, additional water supply infrastructure can, in some circumstances and taking into account of the cost benefit dimension, serve as an alternative approach to mitigate the impacts of severe drought. [Am. 5] |
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(4)

The Communication from the Commission to the European Parliament and the Council ‘Addressing the challenge of water scarcity and droughts in the European Union’ (7) sets out the hierarchy of measures that Member States should consider in managing water scarcity and droughts.
  For the same purpose, it would be advisable to lay down within Directive 2000/60/EC a binding hierarchy of measures for the sound management of water
  . It states that in regions where all preventive measures have been implemented according to the water hierarchy and where demand for water still exceeds availability, additional water supply infrastructure can, in some circumstances and taking into account of the cost benefit dimension, serve as an alternative approach to mitigate the impacts of severe drought. [Am. 5]

| (4a) | The European Parliament resolution of 9 October 2008 on addressing the challenge of water scarcity and droughts in the European Union
   (8)

  recalls that a demand-side approach should be preferred when managing water resources and takes the view that the Union should adopt a holistic approach when managing water resources, combining measures of demand management, measures to optimise existing resources within the water cycle, and measures to create new resources, and that the approach needs to integrate environmental, social and economic considerations. [Am. 6] |
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(4a)

The European Parliament resolution of 9 October 2008 on addressing the challenge of water scarcity and droughts in the European Union
   (8)

  recalls that a demand-side approach should be preferred when managing water resources and takes the view that the Union should adopt a holistic approach when managing water resources, combining measures of demand management, measures to optimise existing resources within the water cycle, and measures to create new resources, and that the approach needs to integrate environmental, social and economic considerations. [Am. 6]

| (5) | In its Action Plan for the Circular Economy (9) the Commission committed to taking a series of actions to promote the reuse of treated waste water, including the development of a legislative proposal on minimum requirements for water reuse.
  The Commission should update its Action Plan and keep water resources as a priority area in which to intervene. [Am. 7] |
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(5)

In its Action Plan for the Circular Economy (9) the Commission committed to taking a series of actions to promote the reuse of treated waste water, including the development of a legislative proposal on minimum requirements for water reuse.
  The Commission should update its Action Plan and keep water resources as a priority area in which to intervene. [Am. 7]

| (6) | Reuse of appropriately treated waste water, for example from urban waste water treatment plants or industrial installations, is considered to have a lower environmental impact than other alternative water supply methods, such as water transfers or desalination,. But such reuse
  , which could reduce water wastage and save water,
  only occurs to a limited extent in the Union. This appears to be partly due to
  the significant cost of waste water reuse system and
  the lack of common Union environmental or

  and
  health standards for water reuse, and, as regards in particular agricultural products, the potential
  health and environmental risks and potential
  obstacles to the free movement of such products irrigated with reclaimed water.
  At the same time, it should be borne in mind that, in certain Member States, the irrigation infrastructure is inadequate or non-existent. [Am. 8] |
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(6)

Reuse of appropriately treated waste water, for example from urban waste water treatment plants or industrial installations, is considered to have a lower environmental impact than other alternative water supply methods, such as water transfers or desalination,. But such reuse
  , which could reduce water wastage and save water,
  only occurs to a limited extent in the Union. This appears to be partly due to
  the significant cost of waste water reuse system and
  the lack of common Union environmental or

  and
  health standards for water reuse, and, as regards in particular agricultural products, the potential
  health and environmental risks and potential
  obstacles to the free movement of such products irrigated with reclaimed water.
  At the same time, it should be borne in mind that, in certain Member States, the irrigation infrastructure is inadequate or non-existent. [Am. 8]

| (6a) | Water reuse could contribute to the recovery of the nutrients contained in treated waste water, and the use of recovered water for irrigation purposes in agriculture or forestry could be a way of restoring nutrients, such as nitrogen, phosphorus and potassium, to natural biogeochemical cycles. [Am. 9] |
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(6a)

Water reuse could contribute to the recovery of the nutrients contained in treated waste water, and the use of recovered water for irrigation purposes in agriculture or forestry could be a way of restoring nutrients, such as nitrogen, phosphorus and potassium, to natural biogeochemical cycles. [Am. 9]

| (6b) | The reuse of adequately treated reclaimed water for irrigation purposes pursuant to this Regulation should be environmentally friendly. It should not, therefore, result in increased nitrogen and phosphorus release, as excess of such nutrients leads to the eutrophication of soils and surface and ground water bodies, damaging ecosystems and contributing to the reduction of biodiversity. [Am. 10] |
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(6b)

The reuse of adequately treated reclaimed water for irrigation purposes pursuant to this Regulation should be environmentally friendly. It should not, therefore, result in increased nitrogen and phosphorus release, as excess of such nutrients leads to the eutrophication of soils and surface and ground water bodies, damaging ecosystems and contributing to the reduction of biodiversity. [Am. 10]

| (6c) | If the effective reuse of urban waste water resources is to be guaranteed, it should be acknowledged that not all types of recycled water can be used for all crops. Farmers should therefore be trained to use the various types of recycled water in an optimum way for crops in respect of which the quality of the water used has no public health implications. [Am. 11] |
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(6c)

If the effective reuse of urban waste water resources is to be guaranteed, it should be acknowledged that not all types of recycled water can be used for all crops. Farmers should therefore be trained to use the various types of recycled water in an optimum way for crops in respect of which the quality of the water used has no public health implications. [Am. 11]

| (7) | Equivalent
  health standards in relation to food hygiene for agricultural products irrigated with reclaimed water can be achieved only if quality requirements for reclaimed water destined for agricultural irrigation do not differ significantly in Member States. Harmonisation of requirements will also contribute to the efficient functioning of the internal market in relation to such products. It is therefore appropriate to introduce minimum harmonisation by setting minimum requirements for water quality, and

  the frequency of
  monitoring
  and key risk management tasks
  . Those minimum requirements should consist of minimum parameters for reclaimed water and other stricter or additional quality requirements imposed, if necessary, by competent authorities together with any relevant preventive measures. In order to identify stricter or additional requirements for water quality, the

  The reclamation facility operator should draft a Water Reuse Risk Management Plan in cooperation with the relevant actors involved and should be allowed to identify stricter or additional requirements for the quality of the reclaimed water. The
  reclamation plant operators

  facility operator
  should perform key risk management tasks
  in cooperation at least with the reclaimed water distribution operator and the reclaimed water storage operator. The Water Reuse Risk Management Plan should be kept constantly updated and drafted in accordance with internationally recognised standardised procedures
  . The parameters are based on the technical report of the Commission Joint Research Centre and reflect the international standards on water reuse.
  The Commission Joint Research Centre should develop parameters and measurement methods to identify the presence of microplastics and pharmaceutical residues in reclaimed water. [Am. 12] |
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(7)

Equivalent
  health standards in relation to food hygiene for agricultural products irrigated with reclaimed water can be achieved only if quality requirements for reclaimed water destined for agricultural irrigation do not differ significantly in Member States. Harmonisation of requirements will also contribute to the efficient functioning of the internal market in relation to such products. It is therefore appropriate to introduce minimum harmonisation by setting minimum requirements for water quality, and

  the frequency of
  monitoring
  and key risk management tasks
  . Those minimum requirements should consist of minimum parameters for reclaimed water and other stricter or additional quality requirements imposed, if necessary, by competent authorities together with any relevant preventive measures. In order to identify stricter or additional requirements for water quality, the

  The reclamation facility operator should draft a Water Reuse Risk Management Plan in cooperation with the relevant actors involved and should be allowed to identify stricter or additional requirements for the quality of the reclaimed water. The
  reclamation plant operators

  facility operator
  should perform key risk management tasks
  in cooperation at least with the reclaimed water distribution operator and the reclaimed water storage operator. The Water Reuse Risk Management Plan should be kept constantly updated and drafted in accordance with internationally recognised standardised procedures
  . The parameters are based on the technical report of the Commission Joint Research Centre and reflect the international standards on water reuse.
  The Commission Joint Research Centre should develop parameters and measurement methods to identify the presence of microplastics and pharmaceutical residues in reclaimed water. [Am. 12]

| (7a) | The presence of microplastics can pose a risk to human health and the environment. Therefore, as part of an in-depth review of the sources, distribution, fate and effects of microplastics in the context of waste water treatment, the Commission should develop a methodology for measuring microplastics in urban waste water treated in accordance with Directive 91/271/EEC and reclaimed in accordance with this Regulation. [Am. 13] |
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(7a)

The presence of microplastics can pose a risk to human health and the environment. Therefore, as part of an in-depth review of the sources, distribution, fate and effects of microplastics in the context of waste water treatment, the Commission should develop a methodology for measuring microplastics in urban waste water treated in accordance with Directive 91/271/EEC and reclaimed in accordance with this Regulation. [Am. 13]

| (7b) | The use of insufficiently clean waste water for public services, such as street cleaning or irrigation of parks and golf courses, can be harmful to health. The Commission should therefore set quality targets regarding the water reuse for public services with a view to protecting human and animal health and the quality of groundwater and surface water. [Am. 14] |
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(7b)

The use of insufficiently clean waste water for public services, such as street cleaning or irrigation of parks and golf courses, can be harmful to health. The Commission should therefore set quality targets regarding the water reuse for public services with a view to protecting human and animal health and the quality of groundwater and surface water. [Am. 14]

| (7c) | The quality requirements for water used for irrigation should take account of scientific progress, in particular as regards tests for micropollutants and new ‘emerging’ substances, in order to guarantee safe water use and protect the environment and public health. [Am. 15] |
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(7c)

The quality requirements for water used for irrigation should take account of scientific progress, in particular as regards tests for micropollutants and new ‘emerging’ substances, in order to guarantee safe water use and protect the environment and public health. [Am. 15]

| (7d) | Water quality requirements should take account of experiments which have been carried out, particularly on the use in agriculture of sewage sludge and methanisation effluents. [Am. 16] |
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(7d)

Water quality requirements should take account of experiments which have been carried out, particularly on the use in agriculture of sewage sludge and methanisation effluents. [Am. 16]

| (8) | The adherence to minimum requirements for water reuse should
  be consistent with Union water policy and
  help support the achievement of the Sustainable Development Goals of the United Nations 2030 Agenda for Sustainable Development, in particular Goal 6, to ensure the availability and sustainable management of water and sanitation for all as well as a substantial increase in recycling
  of water
  and safe
  water
  reuse of water globally
  with a view to contributing to achieving United Nations Sustainable Development Goal 12, on sustainable consumption and production
  . Furthermore, this Regulation seeks to ensure the application of Article 37 on environmental protection of the Charter of Fundamental Rights of the European Union. [Am. 17] |
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(8)

The adherence to minimum requirements for water reuse should
  be consistent with Union water policy and
  help support the achievement of the Sustainable Development Goals of the United Nations 2030 Agenda for Sustainable Development, in particular Goal 6, to ensure the availability and sustainable management of water and sanitation for all as well as a substantial increase in recycling
  of water
  and safe
  water
  reuse of water globally
  with a view to contributing to achieving United Nations Sustainable Development Goal 12, on sustainable consumption and production
  . Furthermore, this Regulation seeks to ensure the application of Article 37 on environmental protection of the Charter of Fundamental Rights of the European Union. [Am. 17]

| (8a) | The quality requirements for water intended for human consumption are laid down in Directive (EU) .../... of the European Parliament and of the Council
   (10)

  . Member States should take appropriate measures to ensure that water resources used for drinking purposes are not contaminated with reclaimed water, in order to avoid deterioration in drinking water quality. [Am. 18] |
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(8a)

The quality requirements for water intended for human consumption are laid down in Directive (EU) .../... of the European Parliament and of the Council
   (10)

  . Member States should take appropriate measures to ensure that water resources used for drinking purposes are not contaminated with reclaimed water, in order to avoid deterioration in drinking water quality. [Am. 18]

| (8b) | In some cases, the reclamation facility operators still transport and store the reclaimed water beyond the outlet of the reclamation facility, prior to delivering the reclaimed water to the next actors in the chain, such as the reclaimed water distribution operator, the reclaimed water storage operator, or the end-user. It is necessary to define the point of compliance to clarify where the responsibility of the reclamation facility operator ends and where the responsibility of the next actor in the chain starts. [Am. 19] |
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(8b)

In some cases, the reclamation facility operators still transport and store the reclaimed water beyond the outlet of the reclamation facility, prior to delivering the reclaimed water to the next actors in the chain, such as the reclaimed water distribution operator, the reclaimed water storage operator, or the end-user. It is necessary to define the point of compliance to clarify where the responsibility of the reclamation facility operator ends and where the responsibility of the next actor in the chain starts. [Am. 19]

| (9) | Risk management should comprise identifying and managing risks in a proactive way and incorporate the concept of producing

  production, distribution, storage and use of
  reclaimed water of a quality required for particular uses. The risk assessment should be based on key risk management tasks
  and on a thorough application of, inter alia, the precautionary principle,
  and should identify any additional water quality requirements necessary to ensure sufficient protection of the environment, human and animal health.
  Risk management should be a responsibility shared among all the relevant actors involved in the Water Reuse Risk Management Plan. The roles and responsibilities of the actors involved should be clearly specified in the Water Reuse Risk Management Plan. When granting a permit, the competent authority should be able to require further risk management measures to be carried out by the relevant actors involved in the Water Reuse Risk Management Plan. [Am. 20] |
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(9)

Risk management should comprise identifying and managing risks in a proactive way and incorporate the concept of producing

  production, distribution, storage and use of
  reclaimed water of a quality required for particular uses. The risk assessment should be based on key risk management tasks
  and on a thorough application of, inter alia, the precautionary principle,
  and should identify any additional water quality requirements necessary to ensure sufficient protection of the environment, human and animal health.
  Risk management should be a responsibility shared among all the relevant actors involved in the Water Reuse Risk Management Plan. The roles and responsibilities of the actors involved should be clearly specified in the Water Reuse Risk Management Plan. When granting a permit, the competent authority should be able to require further risk management measures to be carried out by the relevant actors involved in the Water Reuse Risk Management Plan. [Am. 20]

| (9a) | Cooperation and interaction between the various parties involved in the water reclamation process should be a precondition for setting up reclamation treatment procedures in accordance with the requirements for specific uses and in order to be able to plan the supply of reclaimed water in line with demand from end-users. [Am. 21] |
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(9a)

Cooperation and interaction between the various parties involved in the water reclamation process should be a precondition for setting up reclamation treatment procedures in accordance with the requirements for specific uses and in order to be able to plan the supply of reclaimed water in line with demand from end-users. [Am. 21]

| (10) | In order to effectively protect the environment
  , including soil quality,
  and human health, reclamation plant

  facility
  operators should be primarily responsible for the quality of reclaimed water
  at the point of compliance
  . For the purposes of compliance with the minimum requirements and any additional conditions, set by the competent authority, reclamation plant

  facility
  operators should monitor the quality of reclaimed water
  in accordance with the minimum requirements and any additional conditions set by the competent authorities
  . It is therefore appropriate to establish the minimum requirements for monitoring, consisting of the frequencies of the routine monitoring and the timing and performance targets for validation monitoring. Certain requirements for routine monitoring are specified in accordance with Directive 91/271/EEC. [Am. 22] |
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(10)

In order to effectively protect the environment
  , including soil quality,
  and human health, reclamation plant

  facility
  operators should be primarily responsible for the quality of reclaimed water
  at the point of compliance
  . For the purposes of compliance with the minimum requirements and any additional conditions, set by the competent authority, reclamation plant

  facility
  operators should monitor the quality of reclaimed water
  in accordance with the minimum requirements and any additional conditions set by the competent authorities
  . It is therefore appropriate to establish the minimum requirements for monitoring, consisting of the frequencies of the routine monitoring and the timing and performance targets for validation monitoring. Certain requirements for routine monitoring are specified in accordance with Directive 91/271/EEC. [Am. 22]

| (11) | It is necessary to ensure the safe
  supply, storage and
  use of reclaimed water, thereby encouraging
  the development of
  water reuse at Union level
  , encouraging Union farmers in particular to adopt this practice
  and enhancing public confidence in it.
  The quantities of treated waste water used, its nature, the treatment methods and its characteristics, regardless of how it is used, should be such that its handling, use and storage, including spraying, drip irrigation, stored or not, does not directly or indirectly affect human or animal health or the quality of soil and aquatic environments in the short, medium and long term
  . Supply
  and storage
  of reclaimed water for particular uses should therefore only be permitted on the basis of a permit, granted by competent authorities of Member States. In order to ensure harmonised approach at Union level, traceability and transparency, the substantive rules for that permit should be laid down at the Union level. However, the details of the procedures for granting permits should be determined by Member States
  , the competent authorities of which are themselves responsible for assessing the risks linked to water reuse
  . Member States should be able to apply existing procedures for granting permits which should be adapted to take account of the requirements introduced by this Regulation. [Am. 23] |
| --- | --- |

(11)

It is necessary to ensure the safe
  supply, storage and
  use of reclaimed water, thereby encouraging
  the development of
  water reuse at Union level
  , encouraging Union farmers in particular to adopt this practice
  and enhancing public confidence in it.
  The quantities of treated waste water used, its nature, the treatment methods and its characteristics, regardless of how it is used, should be such that its handling, use and storage, including spraying, drip irrigation, stored or not, does not directly or indirectly affect human or animal health or the quality of soil and aquatic environments in the short, medium and long term
  . Supply
  and storage
  of reclaimed water for particular uses should therefore only be permitted on the basis of a permit, granted by competent authorities of Member States. In order to ensure harmonised approach at Union level, traceability and transparency, the substantive rules for that permit should be laid down at the Union level. However, the details of the procedures for granting permits should be determined by Member States
  , the competent authorities of which are themselves responsible for assessing the risks linked to water reuse
  . Member States should be able to apply existing procedures for granting permits which should be adapted to take account of the requirements introduced by this Regulation. [Am. 23]

| (11a) | Supply and storage of reclaimed water as well as its use by end-users constitute an integral part of the water reuse system. Within the process of supply and storage the reclaimed water can undergo changes that can negatively affect its chemical and biological quality. Reclaimed water should be appropriately used with respect to the classes of reclaimed water, the crops characteristics and irrigation methods. Key risk management tasks should take into account the potential adverse effects on health and environmental matrices associated with the supply, storage and intended use of reclaimed water. In this respect the Commission should establish guidance documents to assist the competent authorities in carrying out the control and monitoring of the supply, storage and use of reclaimed water. [Am. 24] |
| --- | --- |

(11a)

Supply and storage of reclaimed water as well as its use by end-users constitute an integral part of the water reuse system. Within the process of supply and storage the reclaimed water can undergo changes that can negatively affect its chemical and biological quality. Reclaimed water should be appropriately used with respect to the classes of reclaimed water, the crops characteristics and irrigation methods. Key risk management tasks should take into account the potential adverse effects on health and environmental matrices associated with the supply, storage and intended use of reclaimed water. In this respect the Commission should establish guidance documents to assist the competent authorities in carrying out the control and monitoring of the supply, storage and use of reclaimed water. [Am. 24]

| (11b) | If a reclaimed water distribution operator and a reclaimed water storage operator are needed, any such operator should be subject to a permit. If all requirements for the permit are met, the competent authority in the Member State should grant a permit that should contain all the necessary conditions and measures established in the risk assessment for the purposes of safe distribution and storage of reclaimed water to the end-user. [Am. 25] |
| --- | --- |

(11b)

If a reclaimed water distribution operator and a reclaimed water storage operator are needed, any such operator should be subject to a permit. If all requirements for the permit are met, the competent authority in the Member State should grant a permit that should contain all the necessary conditions and measures established in the risk assessment for the purposes of safe distribution and storage of reclaimed water to the end-user. [Am. 25]

| (12) | The provisions of this Regulation are complementary to the requirements of other Union legislation, in particular with regard to possible health and environmental risks. In order to ensure a holistic approach to addressing possible human, and animal health, and environmental

  plant health
  risks, the reclamation plant operators and

  in addition to those relating to environmental protection, when applicable,
  the competent authorities should therefore take into account

  comply with
  the requirements laid down in other relevant Union legislation, in particular Council Directives 86/278/EEC (11), 91/676/EEC (12) and 98/83/EC (13), Directives 91/271/EEC and 2000/60/EC, Regulations (EC) No 178/2002 (14), (EC) No 852/2004 (15), (EC) No 183/2005 (16), (EC) No 396/2005 (17) and (EC) No 1069/2009 (18) of the European Parliament and of the Council, Directives 2006/7/EC (19), 2006/118/EC (20), 2008/105/EC (21) and 2011/92/EU (22) of the European Parliament and of the Council, Commission Regulations (EC) No 2073/2005 (23), (EC) No 1881/2006 (24) and (EU) No 142/2011 (25). [Am. 26] |
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(12)

The provisions of this Regulation are complementary to the requirements of other Union legislation, in particular with regard to possible health and environmental risks. In order to ensure a holistic approach to addressing possible human, and animal health, and environmental

  plant health
  risks, the reclamation plant operators and

  in addition to those relating to environmental protection, when applicable,
  the competent authorities should therefore take into account

  comply with
  the requirements laid down in other relevant Union legislation, in particular Council Directives 86/278/EEC (11), 91/676/EEC (12) and 98/83/EC (13), Directives 91/271/EEC and 2000/60/EC, Regulations (EC) No 178/2002 (14), (EC) No 852/2004 (15), (EC) No 183/2005 (16), (EC) No 396/2005 (17) and (EC) No 1069/2009 (18) of the European Parliament and of the Council, Directives 2006/7/EC (19), 2006/118/EC (20), 2008/105/EC (21) and 2011/92/EU (22) of the European Parliament and of the Council, Commission Regulations (EC) No 2073/2005 (23), (EC) No 1881/2006 (24) and (EU) No 142/2011 (25). [Am. 26]

| (12a) | For the purposes of this Regulation, it should be possible for treatment operations and urban waste water reclamation operations to take place in the same physical location, using the same facility, or different, separate facilities. In addition, it should be possible for the same actor to be both the treatment plant operator and the reclamation facility operator. [Am. 27] |
| --- | --- |

(12a)

For the purposes of this Regulation, it should be possible for treatment operations and urban waste water reclamation operations to take place in the same physical location, using the same facility, or different, separate facilities. In addition, it should be possible for the same actor to be both the treatment plant operator and the reclamation facility operator. [Am. 27]

| (13) | Regulation (EC) No 852/2004 lays down general rules for food business operators and covers the production, processing, distribution and placing on the market of food intended for human consumption. That Regulation addresses the health quality of food and one of its main principles is that the primary responsibility for food safety is borne by the food business operator. That Regulation is also subject to detailed guidance, of particular relevance being the Commission Notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene (2017/C 163/01). The performance targets for reclaimed water laid down in this Regulation do not preclude food business operators from obtaining the water quality required to comply with Regulation (EC) No 852/2004 using at a subsequent stage several water treatment options alone or in combination with other non-treatment options. |
| --- | --- |

(13)

Regulation (EC) No 852/2004 lays down general rules for food business operators and covers the production, processing, distribution and placing on the market of food intended for human consumption. That Regulation addresses the health quality of food and one of its main principles is that the primary responsibility for food safety is borne by the food business operator. That Regulation is also subject to detailed guidance, of particular relevance being the Commission Notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene (2017/C 163/01). The performance targets for reclaimed water laid down in this Regulation do not preclude food business operators from obtaining the water quality required to comply with Regulation (EC) No 852/2004 using at a subsequent stage several water treatment options alone or in combination with other non-treatment options.

| (13a) | With a view to a better promotion of water reuse operations, the indication of specific uses within this Regulation should not preclude Member States from allowing the use of reclaimed water for further purposes, including reuse for industrial, amenity-related and environmental purposes, provided that Member States ensure compliance with the obligation to ensure a high level of protection of human and animal health and the environment. [Am. 28] |
| --- | --- |

(13a)

With a view to a better promotion of water reuse operations, the indication of specific uses within this Regulation should not preclude Member States from allowing the use of reclaimed water for further purposes, including reuse for industrial, amenity-related and environmental purposes, provided that Member States ensure compliance with the obligation to ensure a high level of protection of human and animal health and the environment. [Am. 28]

| (14) | In order to encourage confidence in water reuse, information should be provided to the public. Making available of
  clear, comprehensive and updated
  information on water reuse should allow for increased transparency and traceability and could also be of particular interest to other relevant authorities for whom the specific water reuse has implications.
  In order to encourage water reuse, Member States should ensure that information awareness-raising campaigns that are specific and adapted to the different actors concerned are developed, with a view to making those actors aware of the urban water cycle, the need to reuse water and the benefits deriving from water reuse, thereby promoting stakeholder acceptance of and involvement in water reuse practices. [Am. 29] |
| --- | --- |

(14)

In order to encourage confidence in water reuse, information should be provided to the public. Making available of
  clear, comprehensive and updated
  information on water reuse should allow for increased transparency and traceability and could also be of particular interest to other relevant authorities for whom the specific water reuse has implications.
  In order to encourage water reuse, Member States should ensure that information awareness-raising campaigns that are specific and adapted to the different actors concerned are developed, with a view to making those actors aware of the urban water cycle, the need to reuse water and the benefits deriving from water reuse, thereby promoting stakeholder acceptance of and involvement in water reuse practices. [Am. 29]

| (14a) | Education and training of the end-users involved in agricultural irrigation are of primary importance as components of implementing and maintaining preventive measures. End-users should be fully informed of the appropriate use of reclaimed water, as they are especially vulnerable. A range of human exposure preventive measures should be implemented, such as use of personal protective equipment, handwashing and personal hygiene. The monitoring of the proper application of such measures should be a part of the key risk management tasks. [Am. 30] |
| --- | --- |

(14a)

Education and training of the end-users involved in agricultural irrigation are of primary importance as components of implementing and maintaining preventive measures. End-users should be fully informed of the appropriate use of reclaimed water, as they are especially vulnerable. A range of human exposure preventive measures should be implemented, such as use of personal protective equipment, handwashing and personal hygiene. The monitoring of the proper application of such measures should be a part of the key risk management tasks. [Am. 30]

| (15) | Directive 2003/4/EC of the European Parliament and of the Council (26) aims at guaranteeing the right of access to environmental information in the Member States in line with the Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (27) (Aarhus Convention). Directive 2003/4/EC lays down extensive obligations related both to making environmental information available upon request and actively disseminating such information. Directive 2007/2/EC of the European Parliament and of the Council (28), covers the sharing of spatial information, including data-sets on different environmental topics. It is important that provisions of this Regulation related to access to information and data-sharing arrangements complement those Directives and do not create a separate legal regime. Therefore, the provisions of this Regulation on information to the public and on information about monitoring of implementation should be without prejudice to Directives 2003/4/EC and 2007/2/EC. |
| --- | --- |

(15)

Directive 2003/4/EC of the European Parliament and of the Council (26) aims at guaranteeing the right of access to environmental information in the Member States in line with the Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (27) (Aarhus Convention). Directive 2003/4/EC lays down extensive obligations related both to making environmental information available upon request and actively disseminating such information. Directive 2007/2/EC of the European Parliament and of the Council (28), covers the sharing of spatial information, including data-sets on different environmental topics. It is important that provisions of this Regulation related to access to information and data-sharing arrangements complement those Directives and do not create a separate legal regime. Therefore, the provisions of this Regulation on information to the public and on information about monitoring of implementation should be without prejudice to Directives 2003/4/EC and 2007/2/EC.

| (16) | In order to adapt the existing minimum requirements and the key risk management tasks to scientific and technical progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the minimum requirements and the key risk management tasks
  , without compromising the scope for reusing properly treated waste water
  . Moreover, in order to ensure a high level of protection of the environment and human health, the Commission should also be able to adopt delegated acts supplementing the key risk management tasks by laying down technical specifications. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (29). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. [Am. 31] |
| --- | --- |

(16)

In order to adapt the existing minimum requirements and the key risk management tasks to scientific and technical progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the minimum requirements and the key risk management tasks
  , without compromising the scope for reusing properly treated waste water
  . Moreover, in order to ensure a high level of protection of the environment and human health, the Commission should also be able to adopt delegated acts supplementing the key risk management tasks by laying down technical specifications. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (29). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. [Am. 31]

| (17) | In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission for the adoption of detailed rules regarding the format and presentation of the information to be provided to the public by Member States, regarding the format and presentation of the information on monitoring of the implementation of this Regulation to be provided by the Member States and regarding the format and presentation of the information as regards the Union-wide overview drawn up by the European Environmental Agency Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (30). |
| --- | --- |

(17)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission for the adoption of detailed rules regarding the format and presentation of the information to be provided to the public by Member States, regarding the format and presentation of the information on monitoring of the implementation of this Regulation to be provided by the Member States and regarding the format and presentation of the information as regards the Union-wide overview drawn up by the European Environmental Agency Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (30).

| (18) | Competent authorities should verify compliance of the reclaimed water with the conditions set out in the permit. In cases of non-compliance, they should require the reclamation plant

  facility
  operator to take the necessary measures to ensure compliance. The operators of reclamation plants

  facilities
  should immediately suspend any supply of the reclaimed water when non-compliance
  exceeds specified maximum values, and as a result
  causes a significant risk to the environment or to human health.
  The competent authorities should work closely with end-users in order to facilitate the reuse of properly treated waste water. Competent authorities should control and monitor the supply, storage and use of the reclaimed water taking into account the relevant health and environment risks. [Am. 32] |
| --- | --- |

(18)

Competent authorities should verify compliance of the reclaimed water with the conditions set out in the permit. In cases of non-compliance, they should require the reclamation plant

  facility
  operator to take the necessary measures to ensure compliance. The operators of reclamation plants

  facilities
  should immediately suspend any supply of the reclaimed water when non-compliance
  exceeds specified maximum values, and as a result
  causes a significant risk to the environment or to human health.
  The competent authorities should work closely with end-users in order to facilitate the reuse of properly treated waste water. Competent authorities should control and monitor the supply, storage and use of the reclaimed water taking into account the relevant health and environment risks. [Am. 32]

| (19) | Competent authorities should cooperate with other relevant authorities, by exchanging information, in order to ensure compliance with relevant Union and national requirements. |
| --- | --- |

(19)

Competent authorities should cooperate with other relevant authorities, by exchanging information, in order to ensure compliance with relevant Union and national requirements.

| (20) | Data provided by Member States is essential to enable the Commission to monitor and assess the performance of the legislation against the objectives it pursues. |
| --- | --- |

(20)

Data provided by Member States is essential to enable the Commission to monitor and assess the performance of the legislation against the objectives it pursues.

| (21) | Pursuant to paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Commission should carry out an evaluation of this Regulation. The evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU value added and should provide the basis for impact assessments of possible further measures. |
| --- | --- |

(21)

Pursuant to paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Commission should carry out an evaluation of this Regulation. The evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU value added and should provide the basis for impact assessments of possible further measures.

| (22) | In accordance with the Aarhus Convention members of the public concerned should have access to justice in order to contribute to the protection of the right to live in an environment which is adequate for health and well-being of individuals. |
| --- | --- |

(22)

In accordance with the Aarhus Convention members of the public concerned should have access to justice in order to contribute to the protection of the right to live in an environment which is adequate for health and well-being of individuals.

| (23) | Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. The penalties should be effective, proportionate and dissuasive. |
| --- | --- |

(23)

Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. The penalties should be effective, proportionate and dissuasive.

| (24) | Since the objectives of this Regulation, namely the protection of environment and human health, cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. |
| --- | --- |

(24)

Since the objectives of this Regulation, namely the protection of environment and human health, cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

| (25) | It is necessary to provide for sufficient time for Member States to set up the administrative infrastructure necessary for the application of this Regulation as well as for operators to prepare for the application of the new rules. |
| --- | --- |

(25)

It is necessary to provide for sufficient time for Member States to set up the administrative infrastructure necessary for the application of this Regulation as well as for operators to prepare for the application of the new rules.

| (25a) | With a view to developing and promoting the reuse of properly treated waste water as much as possible, the European Union should support research and development in this area through the Horizon Europe programme in order to bring about a significant improvement in the reliability of properly treated waste water and in viable use methods. [Am. 33] |
| --- | --- |

(25a)

With a view to developing and promoting the reuse of properly treated waste water as much as possible, the European Union should support research and development in this area through the Horizon Europe programme in order to bring about a significant improvement in the reliability of properly treated waste water and in viable use methods. [Am. 33]

| (25b) | To protect the environment and human health effectively, Member States, in cooperation with stakeholders, should introduce checks on soil quality in the short, medium and long term. [Am. 34] |
| --- | --- |

(25b)

To protect the environment and human health effectively, Member States, in cooperation with stakeholders, should introduce checks on soil quality in the short, medium and long term. [Am. 34]

| (25c) | This Regulation seeks to encourage the sustainable use of water. With that aim in view, the Commission should undertake to use Union programmes, including the LIFE Programme, to support local initiatives involving the reuse of properly treated waste water. [Am. 35] |
| --- | --- |

(25c)

This Regulation seeks to encourage the sustainable use of water. With that aim in view, the Commission should undertake to use Union programmes, including the LIFE Programme, to support local initiatives involving the reuse of properly treated waste water. [Am. 35]

HAVE ADOPTED THIS REGULATION:

Article 1

Subject matter and purpose

1.   This Regulation lays down minimum requirements for
  reclaimed
  water quality and monitoring and the obligation to carry out specified key risk management tasks, for the safe reuse of treated urban waste water in the context of integrated water management,
  and contributes to the objectives set out in Directive 2000/60/EC
  . [Am. 36]

2.   The purpose of this Regulation is to guarantee that reclaimed water is safe for its intended use, thereby ensuring a high level of protection of human and animal health and the environment,
  and at the same time reducing the adverse effects of the use of water resources and improving efficiency,
  addressing water scarcity
  , climate change issues and the environmental objectives of the Union,
  and the resulting pressure on water resources in a coordinated way throughout the Union, thus also contributing to the
  deployment of sustainable water use solutions, supporting the transition to a circular economy, ensuring the long-term competitiveness of the Union and the
  efficient functioning of the internal market. [Am. 37]

2a.
     
  Member States shall ensure that water resources used for drinking water purposes are not contaminated with reclaimed water. [Am. 38]

Article 2

Scope

This Regulation shall apply to reclaimed water destined for a use specified in section 1 of Annex I.

This Regulation shall not apply to pilot projects focusing on water reuse in reclamation plants. [Am. 39]

Article 3

Definitions

For the purposes of this Regulation, the following definitions apply:

| 1. | ‘competent authority’ means an authority or body designated by a Member State to carry out obligations arising from this Regulation; |
| --- | --- |

1.

‘competent authority’ means an authority or body designated by a Member State to carry out obligations arising from this Regulation;

| 2. | ‘water authority’ means an authority or authorities identified in accordance with Article 3(2) or (3) of Directive 2000/60/EC; |
| --- | --- |

2.

‘water authority’ means an authority or authorities identified in accordance with Article 3(2) or (3) of Directive 2000/60/EC;

| 3. | ‘end-user’ means a natural or legal person
  , a public or private entity,
  who uses reclaimed water
  for the use it is intended for
  ; [Am. 40] |
| --- | --- |

3.

‘end-user’ means a natural or legal person
  , a public or private entity,
  who uses reclaimed water
  for the use it is intended for
  ; [Am. 40]

| 4. | ‘urban waste water’ means urban waste water as defined in Article 2(1) of Directive 91/271/EEC; |
| --- | --- |

4.

‘urban waste water’ means urban waste water as defined in Article 2(1) of Directive 91/271/EEC;

| 4a. | ‘treated waste water’ means urban waste water that has been treated in compliance with the requirements set out in Directive 91/271/EEC; [Am. 41] |
| --- | --- |

4a.

‘treated waste water’ means urban waste water that has been treated in compliance with the requirements set out in Directive 91/271/EEC; [Am. 41]

| 5. | ‘reclaimed water’ means urban

  treated
  waste water that has been treated in compliance with the requirements set out in Directive 91/271/EEC and which results from further treatment in a reclamation plant

  facility that makes its quality suitable for the use it is intended for
  ; [Am. 42] |
| --- | --- |

5.

‘reclaimed water’ means urban

  treated
  waste water that has been treated in compliance with the requirements set out in Directive 91/271/EEC and which results from further treatment in a reclamation plant

  facility that makes its quality suitable for the use it is intended for
  ; [Am. 42]

| 5a. | ‘water reuse’ means use of reclaimed water of a specific quality suitable for a use specified in Section 1 of Annex I, through a distribution system, thereby partially or wholly replacing the use of surface waters or groundwater; [Am. 43] |
| --- | --- |

5a.

‘water reuse’ means use of reclaimed water of a specific quality suitable for a use specified in Section 1 of Annex I, through a distribution system, thereby partially or wholly replacing the use of surface waters or groundwater; [Am. 43]

| 6. | ‘reclamation plant


  facility
  ’ means
  a part of
  an urban waste water treatment plant or other plant

  facility
  that further treats urban waste water complying

  previously treated in accordance
  with the requirements set out in Directive 91/271/EEC in order to produce
  reclaimed
  water that is fit for a use specified in section 1 of Annex I to this Regulation
  and includes any storage infrastructure and any infrastructure designed to deliver the reclaimed water to the reclaimed water distribution infrastructure, or to the end-user
  ; [Am. 44] |
| --- | --- |

6.

‘reclamation plant


  facility
  ’ means
  a part of
  an urban waste water treatment plant or other plant

  facility
  that further treats urban waste water complying

  previously treated in accordance
  with the requirements set out in Directive 91/271/EEC in order to produce
  reclaimed
  water that is fit for a use specified in section 1 of Annex I to this Regulation
  and includes any storage infrastructure and any infrastructure designed to deliver the reclaimed water to the reclaimed water distribution infrastructure, or to the end-user
  ; [Am. 44]

| 7. | ‘reclamation plant


  facility

  operator’ means a natural or legal person who operates or controls a reclamation plant

  facility
  ; [Am. 45] |
| --- | --- |

7.

‘reclamation plant


  facility

  operator’ means a natural or legal person who operates or controls a reclamation plant

  facility
  ; [Am. 45]

| 7a. | ‘reclaimed water distribution infrastructure’ means a system of dedicated pipelines and pumps, or other dedicated transporting facilities, designed to deliver the reclaimed water to the end-user, including any facilities for equalisation, further treatment and storage, outside the reclamation facility; [Am. 46] |
| --- | --- |

7a.

‘reclaimed water distribution infrastructure’ means a system of dedicated pipelines and pumps, or other dedicated transporting facilities, designed to deliver the reclaimed water to the end-user, including any facilities for equalisation, further treatment and storage, outside the reclamation facility; [Am. 46]

| 7b. | ‘reclaimed water distribution operator’ means a natural or legal person which operates or controls the reclaimed water distribution infrastructure; [Am. 47] |
| --- | --- |

7b.

‘reclaimed water distribution operator’ means a natural or legal person which operates or controls the reclaimed water distribution infrastructure; [Am. 47]

| 7c. | ‘reclaimed water storage infrastructure’ means a system of dedicated storage facilities designed to store the reclaimed water; [Am. 48] |
| --- | --- |

7c.

‘reclaimed water storage infrastructure’ means a system of dedicated storage facilities designed to store the reclaimed water; [Am. 48]

| 7d. | ‘reclaimed water storage operator’ means a natural or legal person that operates or controls reclaimed water storage infrastructure; [Am. 49] |
| --- | --- |

7d.

‘reclaimed water storage operator’ means a natural or legal person that operates or controls reclaimed water storage infrastructure; [Am. 49]

| 8. | ‘hazard’ means a biological, chemical, physical or radiological agent that has the potential to cause harm to people, animals, crops or plants, other terrestrial biota, aquatic biota, soils or the general environment; |
| --- | --- |

8.

‘hazard’ means a biological, chemical, physical or radiological agent that has the potential to cause harm to people, animals, crops or plants, other terrestrial biota, aquatic biota, soils or the general environment;

| 9. | ‘risk’ means the likelihood of identified hazards causing harm in a specified timeframe, including the severity of the consequences; |
| --- | --- |

9.

‘risk’ means the likelihood of identified hazards causing harm in a specified timeframe, including the severity of the consequences;

| 10. | ‘risk management’ is a systematic management that consistently ensures the safety of water reuse in a specific context; |
| --- | --- |

10.

‘risk management’ is a systematic management that consistently ensures the safety of water reuse in a specific context;

| 11. | ‘preventive measure’ means any

  appropriate
  action or activity that can be used to prevent or eliminate a health and environmental risk, or reduce it to an acceptable level.; [Am. 50] |
| --- | --- |

11.

‘preventive measure’ means any

  appropriate
  action or activity that can be used to prevent or eliminate a health and environmental risk, or reduce it to an acceptable level.; [Am. 50]

| 11a. | ‘point of compliance’ means the point where a reclamation facility operator delivers the reclaimed water to the next actor in the chain; [Am. 51] |
| --- | --- |

11a.

‘point of compliance’ means the point where a reclamation facility operator delivers the reclaimed water to the next actor in the chain; [Am. 51]

| 11b. | ‘micropollutant’ means an undesirable substance detectable in the environment at a very low concentration, as referred to in Annex VIII to Directive 2000/60/EC. [Am. 52] |
| --- | --- |

11b.

‘micropollutant’ means an undesirable substance detectable in the environment at a very low concentration, as referred to in Annex VIII to Directive 2000/60/EC. [Am. 52]

Article 4

Obligations of reclamation plant


  facility

  operators as regards water quality
  [Am. 53]

1.   Reclamation plant

  facility
  operators shall ensure that reclaimed water destined for a use specified in section 1 of Annex I, shall, at the outlet of the reclamation plant (point of compliance)

  point of compliance
  , comply with the following:

| (a) | the minimum requirements for water quality laid down in Section 2 of Annex I; |
| --- | --- |

(a)

the minimum requirements for water quality laid down in Section 2 of Annex I;

| (b) | any additional conditions set by the competent authority in the relevant permit pursuant to points (b) and (c) of Article 7(3), as regards water quality. [Am. 54] |
| --- | --- |

(b)

any additional conditions set by the competent authority in the relevant permit pursuant to points (b) and (c) of Article 7(3), as regards water quality. [Am. 54]

2.   In order to ensure compliance with the requirements and conditions referred to in paragraph 1, the reclamation plant operator shall monitor water quality in accordance with the following:

| (a) | section 2 of Annex I; |
| --- | --- |

(a)

section 2 of Annex I;

| (b) | any additional conditions set by the competent authority in the relevant permit pursuant to points (b) and (c) of Article 7(3), as regards monitoring. |
| --- | --- |

(b)

any additional conditions set by the competent authority in the relevant permit pursuant to points (b) and (c) of Article 7(3), as regards monitoring.

2a.
     
  Reclamation facility operators shall also ensure that at least the risk management measures set out in the Water Reuse Risk Management Plan referred to in paragraph - 1 of Article 5 are fully implemented within the reclamation facility. [Am. 55]

| 2b | .
  After the point of compliance, the quality of water shall no longer be the responsibility of the reclamation facility operator, and shall become the responsibility of the next actor in the chain
  . [Am. 56] |
| --- | --- |

2b

3.   The Commission is empowered to adopt delegated acts amending this Regulation in accordance with Article 14 in order to adapt to technical and scientific progress the minimum requirements set out in Section 2 of Annex I.
  [Am. 57]

Article 4a

Obligations of reclaimed water distribution operators, reclaimed water storage operators and end-users

1.
     
  The reclaimed water distribution operator shall maintain the level of quality of reclaimed water within the reclaimed water distribution infrastructure at least at the same level of quality as that laid down in Section 2 of Annex I. The reclaimed water distribution operator shall also ensure that at least the risk management measures set out in the Water Reuse Risk Management Plan referred to in paragraph - 1 of Article 5 are fully implemented within the reclaimed water distribution infrastructure.

When granting a permit in accordance with Article 7, the competent authority may require further risk management measures to be taken as regards tasks to be carried out by the reclaimed water distribution operator and specify additional requirements and preventive measures needed in accordance with points (b) and (c) of Annex II.

2.
     
  The reclaimed water storage operator shall maintain the level of quality of the reclaimed water within the reclaimed water storage infrastructure at least at the same level of quality as that laid down in Section 2 of Annex I. The reclaimed water storage operator shall also ensure that at least the risk management measures set out in the Water Reuse Risk Management Plan referred to in paragraph - 1 of Article 5 are fully implemented within the reclaimed water storage infrastructure.

When granting a permit in accordance with Article 7, the competent authority may require further risk management measures to be taken as regards tasks to be carried out by the reclaimed water storage operator and specify additional requirements and preventive measures needed in accordance with points (b) and (c) of Annex II.

3.
     
  Reclaimed water used by end-users shall be at least of the quality level set out in Section 2 of Annex I. The competent authority may provide for further requirements as regards obligations upon end-users in addition to those set out in Section 2 of Annex I.

4.
     
  The Commission shall establish guidance documents to assist the competent authorities in the implementation of the requirements relating to control and monitoring of the production, distribution, storage and use of the reclaimed water. [Am. 58]

Article 5

Risk management

-1.
     
  The reclamation facility operator shall, in cooperation with the relevant actors referred to in paragraph 1 of this Article, draw-up a Water Reuse Risk Management Plan. The Water Reuse Risk Management Plan shall be based on the key risk management tasks set out in point (a) of Annex II, set out any requirements additional to those specified in Annex I in accordance with point (b) of Annex II, and shall identify hazards, risks and appropriate preventive measures in accordance with point (c) of Annex II. [Am. 59]

1.   For the purposes of producing and supplying

  ensuring safe production, distribution, storage and use of
  reclaimed water, risk management shall be undertaken by the reclamation plant operator

  the competent authority shall oversee risk management
  in consultation with the following actors: [Am. 60]

| (a) | the operator of the urban waste water treatment plant(s) supplying a reclamation plant with water,

  facility with treated waste water in accordance with the quality requirement set out in Directive 91/271/EEC
  if different from the reclamation plant

  faiclity
  operator; [Am. 61] |
| --- | --- |

(a)

the operator of the urban waste water treatment plant(s) supplying a reclamation plant with water,

  facility with treated waste water in accordance with the quality requirement set out in Directive 91/271/EEC
  if different from the reclamation plant

  faiclity
  operator; [Am. 61]

| (aa) | the reclamation facility operator; [Am. 62] |
| --- | --- |

(aa)

the reclamation facility operator; [Am. 62]

| (ab) | the reclaimed water distribution operator; [Am. 63] |
| --- | --- |

(ab)

the reclaimed water distribution operator; [Am. 63]

| (ac) | the reclaimed water storage operator; [Am. 64] |
| --- | --- |

(ac)

the reclaimed water storage operator; [Am. 64]

| (b) | end-user(s); |
| --- | --- |

(b)

end-user(s);

| (c) | any other party deemed relevant by the reclamation plant operator

  competent authority
  . [Am. 65] |
| --- | --- |

(c)

any other party deemed relevant by the reclamation plant operator

  competent authority
  . [Am. 65]

2.   The reclamation plant

  facility
  operator, shall draw-up a

  the reclaimed water distribution operator and the reclaimed water storage operator shall carry out at least the risk management tasks defined in the
  Water Reuse Risk Management Plan based on the key risk management tasks set out in Annex II. The Water Reuse Risk Management Plan shall propose any additional requirements to those specified in Annex I necessary to further mitigate any risks, and shall, inter alia, identify hazards, risks and appropriate preventive measures

  referred to in paragraph - 1. Risk management methods used by the reclamation facility operator, the reclaimed water distribution operator and the reclaimed water storage operator shall be based on internationally recognised methodologies. [Am. 66]

2a.
     
  In the relevant permit granted in accordance with Article 7, the competent authority may specify different tasks and responsibilities for the different actors involved in the Water Reuse Risk Management Plan. [Am. 67]

2b.
     
  If the type of crop to be irrigated is to be marketed in several different forms and falls into several different reclaimed water quality classes, the reclamation facility operator shall be required to provide the farmer with water corresponding to the highest of the quality classes concerned. [Am. 68]

3.   The Commission is empowered to adopt, in accordance with Article 14, delegated acts amending this Regulation in order to adapt to technical and scientific progress the key risk management tasks set out in Annex II.
  [Am. 69]

The Commission is also empowered to adopt, in accordance with Article 14, delegated acts supplementing this Regulation in order to lay down technical specifications of the key risk management tasks set out in Annex II. [Am. 70]

By ... [1 year after the date of entry into force of this Regulation] the Commission shall adopt delegated acts in accordance with Article 14 to supplement this Regulation by introducing a methodology for measuring the presence of microplastics in reclaimed water which may be subject to additional requirements based on the risk assessment referred to in point 4 of Annex II. [Am. 133]

3a.
     
  If an end-user suspects that the water stored as provided for in Article 4a(2) does not meet the minimum requirements laid down in this Regulation, she or he shall:

| (a) | inform immediately the health authority concerned and provide it, if appropriate, with all information available; |
| --- | --- |

(a)

inform immediately the health authority concerned and provide it, if appropriate, with all information available;

| (b) | cooperate fully with the competent authority concerned in order to verify and determine the grounds for suspicion and the possible presence of unauthorised substances or values as referred to in Tables 2 and 4 of Section 2 of Annex I. [Am. 71] |
| --- | --- |

(b)

cooperate fully with the competent authority concerned in order to verify and determine the grounds for suspicion and the possible presence of unauthorised substances or values as referred to in Tables 2 and 4 of Section 2 of Annex I. [Am. 71]

Article 6

Application for a permit to supply


  produce, distribute and store

  reclaimed water
  [Am. 72]

1.   Any supply

  production, distribution or storage
  of reclaimed water destined for a use specified in section 1 of Annex I, shall be subject to a permit. [Am. 73]

2.   An

  A reclamation facility
  operator shall submit an application for the permit referred to in paragraph 1, or for a modification of an existing permit to the competent authority of the Member State in which the reclamation plant

  facility
  operates or is planned to operate. [Am. 74]

3.   The application shall include the following:

| (a) | a Water Reuse Risk Management Plan drawn up in accordance with
  paragraph - 1 of
  Article 5(2)

  5
  ; [Am. 75] |
| --- | --- |

(a)

a Water Reuse Risk Management Plan drawn up in accordance with
  paragraph - 1 of
  Article 5(2)

  5
  ; [Am. 75]

| (aa) | the latest available data demonstrating the compliance of treated waste water within the meaning of Directive 91/271/EEC at the waste water treatment plant from which the water to be recovered originates; [Am. 76] |
| --- | --- |

(aa)

the latest available data demonstrating the compliance of treated waste water within the meaning of Directive 91/271/EEC at the waste water treatment plant from which the water to be recovered originates; [Am. 76]

| (b) | a description of how the reclamation plant

  facility
  operator will comply
  at the point of compliance
  with the minimum requirements for water quality and monitoring set out in section 2 of Annex I; [Am. 77] |
| --- | --- |

(b)

a description of how the reclamation plant

  facility
  operator will comply
  at the point of compliance
  with the minimum requirements for water quality and monitoring set out in section 2 of Annex I; [Am. 77]

| (c) | a description of how the reclamation plant

  facility
  operator will comply
  at the point of compliance
  with the additional requirements proposed in the Water Reuse Risk Management Plan. [Am. 78] |
| --- | --- |

(c)

a description of how the reclamation plant

  facility
  operator will comply
  at the point of compliance
  with the additional requirements proposed in the Water Reuse Risk Management Plan. [Am. 78]

3a.
     
  A reclaimed water distribution operator shall submit an application for the permit referred to in paragraph 1, or for a modification of an existing permit, to the competent authority of the Member State in which the reclaimed water distribution infrastructure operates or is planned to operate. The application shall include a description of how the reclaimed water distribution operator is to comply with the obligations laid down in paragraph 1 of Article 4a. [Am. 79]

3b.
     
  A reclaimed water storage operator shall submit an application for the permit referred to in paragraph 1, or for a modification of an existing permit, to the competent authority of the Member State in which the reclaimed water storage infrastructure operates or is planned to operate. The application shall include a description of how the reclaimed water storage operator is to comply with the obligations laid down in paragraph 2 of Article 4a. [Am. 80]

Article 7

Granting of the permit

1.   For the purposes of assessing the application, the competent authority shall, if appropriate consult and exchange relevant information with the following:

| (a) | other relevant authorities of the same Member State, in particular the water authority,
  and health authorities,
  if different than the competent authority; [Am. 81] |
| --- | --- |

(a)

other relevant authorities of the same Member State, in particular the water authority,
  and health authorities,
  if different than the competent authority; [Am. 81]

| (b) | contact points in potentially affected Member State(s) designated in accordance with Article 9(1). |
| --- | --- |

(b)

contact points in potentially affected Member State(s) designated in accordance with Article 9(1).

2.   The competent authority shall
  assess the application, having recourse to appropriate scientific assistance, and
  decide within 3 months from the receipt of the complete application as referred to in point (a) of Article 6(3)

  paragraphs 2, 3, 3a and 3b of Article 6
  whether to grant
  or refuse
  the permit. Where the competent authority needs more time due to the complexity of the application, it shall inform
  without delay
  the applicant thereof,
  and
  indicate the expected date of granting
  or refusing
  the permit and provide reasons for the extension.
  The competent authority shall, in any case, take a decision no later than six months from the receipt of the complete application as referred to in paragraphs 2, 3, 3a and 3b of Article 6. [Am. 82]

3.   Where the competent authority decides to grant a permit, it shall determine the conditions applicable, which shall include the following, as applicable:

| (a) | conditions in relation to the minimum requirements for water quality and monitoring set out in section 2 of Annex I; |
| --- | --- |

(a)

conditions in relation to the minimum requirements for water quality and monitoring set out in section 2 of Annex I;

| (b) | conditions in relation to the additional requirements proposed in the Water Reuse Risk Management Plan; |
| --- | --- |

(b)

conditions in relation to the additional requirements proposed in the Water Reuse Risk Management Plan;

| (c) | any other conditions necessary to further mitigate

  eliminate
  any unacceptable risks to the human and animal health or the environment. [Am. 83] |
| --- | --- |

(c)

any other conditions necessary to further mitigate

  eliminate
  any unacceptable risks to the human and animal health or the environment. [Am. 83]

3a.
     
  If conditions equivalent to those referred to in points (a) to (c) of paragraph 3 are not already included in the Water Reuse Risk Management Plan referred to in Article 5, the competent authority shall update the plan without delay. [Am. 84]

4.   The permit shall be reviewed regularly and at least every five years and, if necessary, modified.

Article 8

Compliance check

1.   The competent authority shall verify compliance of the reclaimed water with the conditions set out in the permit, at the point of compliance

  permits granted in accordance with Article 7.
  The compliance check shall be performed using the following means: [Am. 85]

| (a) | on-spot checks; |
| --- | --- |

(a)

on-spot checks;

| (b) | use of monitoring data obtained pursuant to this Regulation and Directives 91/271/EEC and 2000/60/EC; |
| --- | --- |

(b)

use of monitoring data obtained pursuant to this Regulation and Directives 91/271/EEC and 2000/60/EC;

| (c) | any other adequate means. |
| --- | --- |

(c)

any other adequate means.

2.   In the event of non-compliance, the competent authority shall require the reclamation plant

  facility
  operator
  , the reclaimed water distribution operator, or the reclaimed water storage operator, as applicable
  , to take any necessary measures to
  promptly
  restore compliance without delay

  and immediately inform the end-users affected
  . [Am. 86]

3.   Where non-compliance causes a significant risk to the environment or to human health,

  the individual value of any parameter exceeds the minimum water quality requirements set out in point (a) of Section 2 of Annex I,
  the reclamation plant

  facility
  operator shall immediately suspend any further supply of the reclaimed water. until the

  The
  competent authority determines

  may determine
  that compliance has been restored
  only after the individual value of the parameter, or parameters, exceeding the relevant minimum water quality requirements has been found below the maximum permitted value in at least three consecutive checks
  . [Am. 87]

4.   If an incident affecting compliance with the permit's conditions occurs, the reclamation plant

  facility
  operator
  , the reclaimed water distribution operator or the reclaimed water storage operator, as applicable,
  shall immediately inform the competent authority and the end-user(s) which may be potentially affected, and communicate to the competent authority the information necessary for assessing the impacts of such an incident. [Am. 88]

4a.
     
  After granting a permit in accordance with Article 7, the competent authority shall regularly verify compliance by the reclamation facility operator, the reclaimed water distribution operator and the reclaimed water storage operator, with the measures set out in the Water Reuse Risk Management Plan. [Am. 89]

4b.
     
  In the event of non-compliance of reclaimed water at the point of compliance and subsequent contamination of soil or agricultural products through distribution and storage of that non-compliant reclaimed water, resulting in health and environmental hazards, the reclamation facility operator shall be held responsible and liable for damages. [Am. 134]

Article 9

Cooperation between Member States

1.   Member States shall designate a contact point to cooperate as appropriate with other Member States' contact points and competent authorities. The role of contact points shall be to provide assistance upon request and coordinate communication between competent authorities. The contact points shall, in particular, receive and transmit requests for assistance.

2.   Member States shall respond to requests for assistance without undue delay.

Article 9a

Information awareness-raising campaigns

1.
     
  Member States shall set up information and awareness raising campaigns targeting potential end-users, including citizens, and concerning the safety of water reuse and the savings of water resources resulting from water reuse.

2.
     
  Member States shall also set up information campaigns for farmers to ensure that they use reclaimed water on crops in an optimal manner, and thereby avoid any adverse health or environmental effects from such use. [Am. 91]

Article 10

Information to the public

1.   Without prejudice to Directives 2003/4/EC and 2007/2/EC,
  and to Article 9(4) of Directive 2000/60/EC,
  Member States shall ensure that adequate and up-to-date
  and accessible
  information on
  water
  reuse of water is available online to the public
  or through other easy-to-use methods, complying with data protection rules
  . That information shall include the following: [Am. 92]

| (a) | the quantity and the quality of the reclaimed water supplied in accordance with this Regulation; |
| --- | --- |

(a)

the quantity and the quality of the reclaimed water supplied in accordance with this Regulation;

| (aa) | use of reclaimed water as a percentage of total freshwater used for the uses covered by this Regulation; [Am. 93] |
| --- | --- |

(aa)

use of reclaimed water as a percentage of total freshwater used for the uses covered by this Regulation; [Am. 93]

| (b) | the percentage of the reclaimed water in the Member State supplied in accordance with this Regulation compared to the total amount of treated urban waste water; |
| --- | --- |

(b)

the percentage of the reclaimed water in the Member State supplied in accordance with this Regulation compared to the total amount of treated urban waste water;

| (ba) | the percentage of the reclaimed water in the Member State supplied in accordance with this Regulation compared to the total amount of treatable urban waste water; [Am. 94] |
| --- | --- |

(ba)

the percentage of the reclaimed water in the Member State supplied in accordance with this Regulation compared to the total amount of treatable urban waste water; [Am. 94]

| (c) | permits granted or modified in accordance with this Regulation, including conditions set by competent authorities in accordance with Article 7(3); |
| --- | --- |

(c)

permits granted or modified in accordance with this Regulation, including conditions set by competent authorities in accordance with Article 7(3);

| (d) | outcome of the compliance check performed in accordance with Article 8(1); |
| --- | --- |

(d)

outcome of the compliance check performed in accordance with Article 8(1);

| (e) | contact points designated in accordance with Article 9(1). |
| --- | --- |

(e)

contact points designated in accordance with Article 9(1).

2.   The information referred to in paragraph 1 shall be updated at least once a year.

2a.
     
  In accordance with Regulation (EC) No 852/2004 laying down general rules applicable to operators in the food sector, which covers the production, processing, distribution and marketing of foodstuffs intended for human consumption, the competent authorities shall inform users of the maximum nutrient content of the properly treated waste water supplied, so that users, including farmers, can satisfy themselves that it is in compliance with the nutrient levels laid down by the relevant Union rules. [Am. 95]

3.   The Commission may, by means of implementing acts, lay down detailed rules regarding the format and presentation of the information to be provided under paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15.
  [Am. 96]

Article 11

Information on monitoring of implementation

1.   Without prejudice to Directives 2003/4/EC and 2007/2/EC, each Member State, assisted by the European Environment Agency, shall:

| (a) | set up and publish by ... [three

  four
  years after the date of entry into force of this Regulation], and update every 6 years thereafter, a data set containing information on the outcome of the compliance check performed in accordance with Article 8(1) and other information to be made available online to the public in accordance with Article 10; [Am. 97] |
| --- | --- |

(a)

set up and publish by ... [three

  four
  years after the date of entry into force of this Regulation], and update every 6 years thereafter, a data set containing information on the outcome of the compliance check performed in accordance with Article 8(1) and other information to be made available online to the public in accordance with Article 10; [Am. 97]

| (b) | set up, publish and update annually thereafter, a data set containing information on cases of non-compliance with the conditions set out in the permit, collected in accordance with Article 8(1) and information about the measures taken in accordance with Article 8(2) and (3). |
| --- | --- |

(b)

set up, publish and update annually thereafter, a data set containing information on cases of non-compliance with the conditions set out in the permit, collected in accordance with Article 8(1) and information about the measures taken in accordance with Article 8(2) and (3).

2.   Member States shall ensure that the Commission, the European Environment Agency and the European Centre for Disease Prevention and Control have access to the data sets referred to in paragraph 1.

3.   On the basis of the data referred to in paragraph 1, the European Environment Agency shall draw up, publish and update, on a regular basis or following a request from the Commission, a Union-wide overview which shall include, as appropriate, indicators for outputs, results and impacts of this Regulation, maps, and Member State reports.

4.   The Commission may, by means of implementing acts, lay down detailed rules regarding the format and presentation of the information to be provided in accordance with paragraph 1 as well as detailed rules regarding the format and presentation of the Union-wide overview referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15.

Article 12

Access to justice

1.   Member States shall ensure that natural or legal persons or their associations, organisations or groups, in accordance with national legislation or practice, have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, actions or omissions related to the implementation of Articles 4 to 8, when one of the following conditions is fulfilled:

| (a) | they have a sufficient interest; |
| --- | --- |

(a)

they have a sufficient interest;

| (b) | they maintain the impairment of a right, where the administrative procedural law of the relevant Member State requires this as a precondition. |
| --- | --- |

(b)

they maintain the impairment of a right, where the administrative procedural law of the relevant Member State requires this as a precondition.

2.   Member States shall determine at what stage decisions, acts or omissions may be challenged.

3.   What constitutes a sufficient interest and impairment of a right shall be determined by Member States, consistently with the objective of giving the public concerned wide access to justice.

To that end, the interest of any non-governmental organisation promoting environmental protection and meeting the requirements under national law shall be deemed sufficient for the purposes of paragraph 1(a).

Such organisations shall also be deemed to have rights capable of being impaired for the purposes of paragraph 1(b).

4.   Paragraphs 1, 2 and 3 shall not exclude the possibility of a preliminary review procedure before an administrative authority and shall not affect the requirement of exhaustion of administrative review procedures prior to recourse to judicial review procedures, where such a requirement exists under national law.

5.   Any review procedure referred to in paragraphs 1 and 4 shall be fair, equitable, timely and not prohibitively expensive.

6.   Member States shall ensure that information is made available to the public on access to administrative and judicial review procedures.

Article 13

Evaluation

1.   The Commission shall, by ... [6

  five
  years after the date of entry into force of this Regulation], carry out an evaluation of this Regulation. The evaluation shall be based at least on the following elements: [Am. 98]

| (a) | the experience gathered from the implementation of this Regulation; |
| --- | --- |

(a)

the experience gathered from the implementation of this Regulation;

| (b) | the data sets set up by Member States in accordance with Article 11(1) and the Union-wide overview drawn up by the European Environment Agency in accordance with Article 11(3); |
| --- | --- |

(b)

the data sets set up by Member States in accordance with Article 11(1) and the Union-wide overview drawn up by the European Environment Agency in accordance with Article 11(3);

| (c) | relevant scientific, analytical and epidemiological data; |
| --- | --- |

(c)

relevant scientific, analytical and epidemiological data;

| (d) | technical and scientific knowledge; |
| --- | --- |

(d)

technical and scientific knowledge;

| (e) | World Health Organization recommendations, where available; |
| --- | --- |

(e)

World Health Organization recommendations, where available;

| (ea) | experiments which have been carried out, in particular as regards the use in agriculture of sewage sludge and methanisation effluents. [Am. 99] |
| --- | --- |

(ea)

experiments which have been carried out, in particular as regards the use in agriculture of sewage sludge and methanisation effluents. [Am. 99]

2.   In the context of the evaluation referred to in paragraph 1, the Commission shall pay particular regard to the following aspects:

| (a) | the minimum requirements set out in Annex I; |
| --- | --- |

(a)

the minimum requirements set out in Annex I;

| (b) | the key risk management tasks set out in Annex II; |
| --- | --- |

(b)

the key risk management tasks set out in Annex II;

| (c) | the additional requirements set by competent authorities pursuant to point (b) and (c) of Article 7(3); |
| --- | --- |

(c)

the additional requirements set by competent authorities pursuant to point (b) and (c) of Article 7(3);

| (d) | the impacts of water reuse on the environment and human health; |
| --- | --- |

(d)

the impacts of water reuse on the environment and human health;

| (da) | the growing presence of micropollutants and new ‘emerging’ substances in reused water. [Am. 100] |
| --- | --- |

(da)

the growing presence of micropollutants and new ‘emerging’ substances in reused water. [Am. 100]

2a.
     
  As part of the evaluation referred to in paragraph 1, the Commission shall assess the feasibility of:

| (a) | extending the scope of this Regulation to reclaimed water intended for further specific uses, including reuse for industrial purposes; |
| --- | --- |

(a)

extending the scope of this Regulation to reclaimed water intended for further specific uses, including reuse for industrial purposes;

| (b) | expanding the requirements of this Regulation to cover the indirect use of treated waste water; |
| --- | --- |

(b)

expanding the requirements of this Regulation to cover the indirect use of treated waste water;

| (c) | laying down minimum requirements applicable to the quality of treated waste water for the purpose of aquifer recharge. [Am. 101] |
| --- | --- |

(c)

laying down minimum requirements applicable to the quality of treated waste water for the purpose of aquifer recharge. [Am. 101]

2b.
     
  Where appropriate, the Commission shall accompany the evaluation referred to in paragraph 1 with a legislative proposal. [Am. 102]

Article 14

Exercise of the delegation

1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.   The power to adopt delegated acts referred to in Article 4(3) and Article 5(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

3.   The delegation of power referred to in Article 4(3) and Article 5(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.   A delegated act adopted pursuant to Article 4(3) and Article 5(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 15

Committee procedure

1.   The Commission shall be assisted by the Committee established by Directive 2000/60/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 16

Penalties

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by ... [three

  four
  years after the date of entry into force of this Regulation], notify the Commission of those rules and of those measures and shall notify it of any subsequent amendment affecting them. [Am. 103]

Article 17

Entry into force and application

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

It shall apply from ... [one year

  two years
  after the date of entry into force of this Regulation]. [Am. 104]

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

Done at ...,

For the European Parliament

The President

For the Council

The President

---

(1)  OJ C ...

1

(2)  OJ C 86, 7.3.2019, p. 353.

2

(3)  Position of the European Parliament of 12 February 2019.

3

(4)  Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

4

(5)  Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (OJ L 135, 30.5.1991, p. 40).

5

(6)  COM(2012)0673.

6

(7)  COM(2007)0414.

7

(8)  

  OJ C 9 E, 15.1.2010, p. 33.

8

OJ C 9 E, 15.1.2010, p. 33.

(9)  COM(2015)0614.

9

(10)  
  Directive (EU) .../... on the quality of water intended for human consumption (OJ ...).

10

Directive (EU) .../... on the quality of water intended for human consumption (OJ ...).

(11)  Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.1986, p. 6).

11

(12)  Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1).

12

(13)  Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).

13

(14)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

14

(15)  Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

15

(16)  Regulation (EC) No 183/2005 of the European Parliament and the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).

16

(17)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

17

(18)  Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).

18

(19)  Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality and repealing Directive 76/160/EEC (OJ L 64, 4.3.2006, p. 37).

19

(20)  Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19).

20

(21)  Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84).

21

(22)  Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1).

22

(23)  Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1).

23

(24)  Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).

24

(25)  Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive Text with EEA relevance (OJ L 54, 26.2.2011, p. 1).

25

(26)  Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).

26

(27)  OJ L 124, 17.5.2005, p. 4.

27

(28)  Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1).

28

(29)  OJ L 123, 12.5.2016, p. 1.

29

(30)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

30

ANNEX I

USES AND MINIMUM REQUIREMENTS

Section 1. Uses of reclaimed water as referred to in Article 2

(a)   Agricultural irrigation

Agricultural irrigation means irrigation of the following types of crops:

| — | food crops consumed raw, meaning crops which are intended for human consumption to be eaten raw or unprocessed; |
| --- | --- |

—

food crops consumed raw, meaning crops which are intended for human consumption to be eaten raw or unprocessed;

| — | processed food crops, meaning crops which are intended for human consumption not to be eaten raw but after a treatment process (i.e. cooked, industrially processed); |
| --- | --- |

—

processed food crops, meaning crops which are intended for human consumption not to be eaten raw but after a treatment process (i.e. cooked, industrially processed);

| — | non-food crops, meaning crops which are not intended for human consumption (e.g. pastures, forage, fiber, ornamental, seed, energy and turf crops). |
| --- | --- |

—

non-food crops, meaning crops which are not intended for human consumption (e.g. pastures, forage, fiber, ornamental, seed, energy and turf crops).

Without prejudice to the relevant Union law in the fields of environment and health, Member States may use reclaimed water for further uses such as industrial water reuse and for amenity-related and environmental purposes. [Am. 105]

Section 2. Minimum requirements

2.1.   Minimum requirements applicable to reclaimed water destined to be used

  intended
  for agricultural irrigation [Am. 106]

The classes of reclaimed water quality and the allowed use and irrigation methods for each class are set out in Table 1. The minimum requirements for water quality are set out in point (a), Table 2. The minimum frequencies and performance targets for monitoring the reclaimed water are set out in point (b), Table 3 (routine monitoring) and Table 4 (validation monitoring).

Table 1 Classes of reclaimed water quality and allowed agricultural use and irrigation method

| Minimum reclaimed water quality class | Crop category | Irrigation method |
| --- | --- | --- |
| A | All food crops, including root crops consumed raw and food crops where the edible part is in direct contact with reclaimed water | All irrigation methods |
| B | Food crops consumed raw where the edible part is produced above ground and is not in direct contact with reclaimed water, processed food crops and non-food crops including crops to feed milk- or meat-producing animals | All irrigation methods |
| C | Drip irrigation
   (*1)
  only

  Only irrigation methods that do not lead to direct contact between the crop and the reclaimed water. For example, drip irrigation
   (*1)
  . [Am. 107] |
| D | Industrial, energy, and seeded crops | All irrigation methods |

Minimum reclaimed water quality class

Crop category

Irrigation method

A

All food crops, including root crops consumed raw and food crops where the edible part is in direct contact with reclaimed water

All irrigation methods

B

Food crops consumed raw where the edible part is produced above ground and is not in direct contact with reclaimed water, processed food crops and non-food crops including crops to feed milk- or meat-producing animals

All irrigation methods

C

Drip irrigation
   (*1)
  only

  Only irrigation methods that do not lead to direct contact between the crop and the reclaimed water. For example, drip irrigation
   (*1)
  . [Am. 107]

D

Industrial, energy, and seeded crops

All irrigation methods

(a)   Minimum requirements for water quality

Table 2 Reclaimed water quality requirements for agricultural irrigation

| Reclaimed water quality class | Indicative technology target
  appropriate treatment | Quality requirements Limit value | |
| --- | --- | --- | --- |
| E.


  coli



  (cfu/100 ml) | BOD5



  (mg/l) | TSS


  (mg/l) | Turbidity


  (NTU) | Other |
| A | Secondary treatment, filtration, and disinfection | ≤10
  or below detection limit | ≤10 | ≤10 | ≤5 | Legionella spp.: <1,000 cfu/l where there is risk of aerosolization in greenhouses
  Intestinal nematodes (helminth eggs): ≤1 egg/l for irrigation of pastures or forage
  Salmonella: absent [Am. 108] |
| B | Secondary treatment, and disinfection | ≤100 | According to Council Directive 91/271/EEC (1)

  (Annex I, Table 1) | According to Directive 91/271/EEC
  (Annex I, Table 1) | — |
| C | Secondary treatment, and disinfection | ≤1,000 | — |
| D | Secondary treatment, and disinfection | ≤10,000 | — |

Reclaimed water quality class

Indicative technology target
  appropriate treatment

Quality requirements Limit value

E.


  coli

(cfu/100 ml)

BOD5

(mg/l)

TSS

(mg/l)

Turbidity

(NTU)

Other

A

Secondary treatment, filtration, and disinfection

≤10

or below detection limit

≤10

≤10

≤5

Legionella spp.: <1,000 cfu/l where there is risk of aerosolization in greenhouses

Intestinal nematodes (helminth eggs): ≤1 egg/l for irrigation of pastures or forage
  Salmonella: absent [Am. 108]

B

Secondary treatment, and disinfection

≤100

According to Council Directive 91/271/EEC (1)

(Annex I, Table 1)

According to Directive 91/271/EEC

(Annex I, Table 1)

—

C

Secondary treatment, and disinfection

≤1,000

—

D

Secondary treatment, and disinfection

≤10,000

—

The reclaimed water will be considered compliant with the requirements set out in Table 2 if the measurements meet all of the following criteria:

| — | The indicated values for E. coli, Legionella spp and Intestinal nematodes are met in 90 % or more of the samples. None of the
  maximum
  values of the samples can exceed the maximum deviation limit of 1 log unit from the indicated value for E. coli and Legionella and 100 % of the indicated value for intestinal nematodes.
  The requirement to ensure that there is an absence of salmonella shall apply to 100 % of samples. [Am. 109] |
| --- | --- |

—

The indicated values for E. coli, Legionella spp and Intestinal nematodes are met in 90 % or more of the samples. None of the
  maximum
  values of the samples can exceed the maximum deviation limit of 1 log unit from the indicated value for E. coli and Legionella and 100 % of the indicated value for intestinal nematodes.
  The requirement to ensure that there is an absence of salmonella shall apply to 100 % of samples. [Am. 109]

| — | The indicated values for BOD5, TSS, and turbidity in Class A are met in 90 % or more of the samples. None of the
  maximum
  values of the samples can exceed the maximum deviation limit of 100 % of the indicated value. [Am. 110] |
| --- | --- |

—

The indicated values for BOD5, TSS, and turbidity in Class A are met in 90 % or more of the samples. None of the
  maximum
  values of the samples can exceed the maximum deviation limit of 100 % of the indicated value. [Am. 110]

b)   Minimum requirements for monitoring

Reclamation plant

  facility
  operators shall perform routine monitoring to verify that the reclaimed water is complying with the minimum water quality requirements set out in point (a). The routine monitoring shall be included in the verification procedures of the water reuse system

  project
  . [Am. 111]

The samples to be used to verify compliance with the microbiological parameters at the point of compliance shall be taken in accordance with standard EN ISO 19458. [Am. 112]

Table 3 Minimum frequencies for routine monitoring of reclaimed water for agricultural irrigation

| | Minimum monitoring frequencies |
| --- | --- |
| Reclaimed water quality class | E. coli | BOD5 | TSS | Turbidity | Legionella spp.
  (when applicable) | Intestinal nematodes
  (when applicable) |
| A | Once
  a week | Once
  a week | Once
  a week | Continuous | Once
  a week | Twice a month or frequency determined by the reclamation plant operator according to the number of eggs in waste water entering the reclamation plant |
| B | Once
  a week | According to Directive 91/271/EEC
  (Annex I, Section D) | According to Directive 91/271/EEC
  (Annex I, Section D) | — |
| C | Twice a month | — |
| D | Twice a month | — |

Minimum monitoring frequencies

Reclaimed water quality class

E. coli

BOD5

TSS

Turbidity

Legionella spp.

(when applicable)

Intestinal nematodes

(when applicable)

A

Once

a week

Once

a week

Once

a week

Continuous

Once

a week

Twice a month or frequency determined by the reclamation plant operator according to the number of eggs in waste water entering the reclamation plant

B

Once

a week

According to Directive 91/271/EEC

(Annex I, Section D)

According to Directive 91/271/EEC

(Annex I, Section D)

—

C

Twice a month

—

D

Twice a month

—

Validation monitoring has to be performed before the reclamation plant

  facility
  is put into operation, when equipment is upgraded, and when new equipment or processes are added
  , and at any time when a new permit is granted or an existing permit is modified
  . [Am. 113]

Validation monitoring shall be performed for the most stringent reclaimed water quality class, Class A, to assess that the performance targets (log10 reduction) are complied with. Validation monitoring entails the monitoring of the indicator microorganisms associated to each group of pathogens (bacteria, virus and protozoa). The indicator microorganisms selected are E. coli for pathogenic bacteria, F-specific coliphages, somatic coliphages or coliphages for pathogenic viruses, and Clostridium perfringens spores or spore-forming sulfate-reducing bacteria for protozoa. Performance targets (log10 reduction) for the validation monitoring for the selected indicator microorganisms are set out in Table 4 and shall be met at the outlet of the reclamation plant (point of compliance)

  facility
  , considering the concentrations of the raw waste water effluent entering the urban waste water treatment plant.
  At least 90 % of validation samples shall reach or exceed the performance target. [Am. 114]

If a biological indicator is not present in sufficient quantity in raw waste water to achieve the log10 reduction, the absence of such biological indicator in the effluent shall mean that the validation requirements are complied with. The performance with the compliance target may be established by analytical control, by addition of the performance granted to individual treatment steps based on scientific evidence for standard well-established processes, such as published data of testing reports, case studies etc., or tested in laboratory under controlled conditions for innovative treatment. [Am. 115]

Table 4 Validation monitoring of reclaimed water for agricultural irrigation

| Reclaimed


  water quality


  class | Indicator microorganisms
   (*2) | Performance targets for the treatment chain


  (log10 reduction) |
| --- | --- | --- |
| A | E. coli | ≥ 5,0 |
| Total coliphages/ F-specific coliphages/somatic coliphages/coliphages (*3) | ≥ 6,0 |
| Clostridium perfringens spores/spore-forming sulfate-reducing bacteria (*4) | ≥ 5,0 |

Reclaimed

water quality

class

Indicator microorganisms
   (*2)

Performance targets for the treatment chain

(log10 reduction)

A

E. coli

≥ 5,0

Total coliphages/ F-specific coliphages/somatic coliphages/coliphages (*3)

≥ 6,0

Clostridium perfringens spores/spore-forming sulfate-reducing bacteria (*4)

≥ 5,0

Methods of analysis for monitoring shall be validated and documented by the operator in accordance with EN ISO/IEC-17025 or other national or international standards which ensure an equivalent quality.
  The reclamation plant operator shall ensure that the laboratories selected for the validation monitoring implement quality management practices in accordance with standard ISO/IEC 17025. [Am. 119]

---

(*1)  Drip irrigation (also called trickle irrigation) is a micro-irrigation system capable of delivering water drops or tiny streams to the plants and involves dripping water onto the soil or directly under its surface at very low rates (2-20 litres/hour) from a system of small diameter plastic pipes fitted with outlets called emitters or drippers.

(1)  Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (OJ L 135, 30.5.1991, p. 40).

(*2)  The reference pathogens Campylobacter, Rotavirus and Cryptosporidium can also be used for validation monitoring purposes instead of the proposed indicator microorganisms. The following log10 reduction performance targets should then apply: Campylobacter (≥ 5,0), Rotavirus (≥ 6,0) and Cryptosporidium (≥ 5,0).
  The national health authority may lay down further indicators relating to the specific case, when there is evidence of a need to ensure that there is a high level of protection of human and animal health and the environment. [Am. 116]

(*3)  Total coliphages is selected as the most appropriate viral indicator. However, if analysis of total coliphages is not feasible, at least one of them (F-specific or somatic coliphages) has to be analysed.
  If total coliphages are not present in sufficient quantity in raw waste water effluent, the compliance with the performance target may be established by addition of the performance granted to individual treatment steps based on scientific evidence for standard well-established processes, such as published data of testing reports, case studies etc., or tested in laboratory under controlled conditions for innovative treatment. [Am. 117]

(*4)  Clostridium perfringens spores is selected as the most appropriate protozoa indicator. However sporeforming sulfate-reducing bacteria is an alternative if the concentration of Clostridium perfringens spores does not allow to validate the requested log10 removal.
  If Clostridium perfringens are not present in sufficient quantity in raw waste water effluent, the compliance with the performance target may be established by addition of the performance granted to individual treatment steps based on scientific evidence for standard well-established processes, such as published data of testing reports, case studies etc, or tested in laboratory under controlled conditions for innovative treatment. [Am. 118]

ANNEX II

(a)
     Key risk management tasks [Am. 120]

| -1. | Conduct a feasibility analysis of the planned reclamation facility that takes into consideration at least the development costs of the facility in relation to regional demand for reclaimed water, the potential end-users and the facility’s treated waste water requirements, and assesses the quality of the treated waste water entering the facility. [Am. 121] |
| --- | --- |

-1.

| 1. | Describe the water reuse system, from the waste water entering the urban waste water treatment plant to the point of use, including the sources of waste water, the treatment steps and technologies at the reclamation plant, the supply and storage infrastructure, the intended use, the place of use, and the quantities of reclaimed water to be supplied. The aim of this task is to provide a detailed description of the entire water reuse system. |
| --- | --- |

1.

| 2. | Identify potential hazards, in particular the presence of pollutants and pathogens, and the potential for hazardous events such as treatment failures, accidental leakages or contamination in the described water reuse system. |
| --- | --- |

2.

| 3. | Identify the environments, populations and individuals at risk of direct or indirect exposure to the identified potential hazards, taking into account specific environmental factors such as local hydrogeology, topology, soil type and ecology, and factors related to the type of crops and farming practices.
  The health risks assessment, including hazard identification, dose-response, exposure assessment and risk characterisation, shall be taken into consideration throughout the stages of the waste water reuse system.
  Possible irreversible or long-term negative
  environmental or health
  effects
  , including the potential negative impacts on ecological flows,
  of the water reclamation operation
  , such as distribution, storage and use,
  have to be considered as well. [Am. 122] |
| --- | --- |

3.

| 4. | Conduct a risk assessment covering both environmental risks and risks to human and animal health, taking into account the nature of the identified potential hazards, the identified environments, populations and individuals at risk of exposure to those hazards and the severity of possible effects of the hazards, as well as all relevant Union and national legislation, guidance documents and minimum requirements in relation to food and feed and worker safety
  and environmental objectives
  .
  Qualitative studies may be used for the purposes of the risk assessment
  . Scientific uncertainty in risk characterisation shall be addressed in accordance with the precautionary principle. [Am. 123]

  The risk assessment shall consist of the following elements:






  (a) | an assessment of environmental risks, including all of the following:






  i. | confirmation of the nature of the hazards, including, where relevant, the predicted no-effect level; |
| --- | --- | --- | --- |

4.

The risk assessment shall consist of the following elements:

(a)

an assessment of environmental risks, including all of the following:

i.

confirmation of the nature of the hazards, including, where relevant, the predicted no-effect level;

| ii. | assessment of the potential range of exposure; |
| --- | --- |

ii.

assessment of the potential range of exposure;

| iii. | characterisation of the risk. |
| --- | --- |

iii.

characterisation of the risk.

| (b) | an assessment of risks to human health, including all of the following:






  i. | confirmation of the nature of the hazards, including, where relevant, the dose-response relationship
  in cooperation with health authorities
  ; [Am. 124] |
| --- | --- | --- |

(b)

an assessment of risks to human health, including all of the following:

i.

confirmation of the nature of the hazards, including, where relevant, the dose-response relationship
  in cooperation with health authorities
  ; [Am. 124]

| ii. | assessment of the potential range of dose or exposure; |
| --- | --- |

ii.

assessment of the potential range of dose or exposure;

| iii. | characterisation of the risk. |
| --- | --- |

iii.

characterisation of the risk.

The following requirements and obligations shall, as a minimum, be
  taken into account


  complied with
  in the risk assessment: [Am. 125]

| (a) | the requirement to reduce and prevent water pollution from nitrates in accordance with Directive 91/676/EEC; |
| --- | --- |

(a)

the requirement to reduce and prevent water pollution from nitrates in accordance with Directive 91/676/EEC;

| (b) | the obligation for drinking water protected areas to meet the requirements of Directive 98/83/EC; |
| --- | --- |

(b)

the obligation for drinking water protected areas to meet the requirements of Directive 98/83/EC;

| (c) | the requirement to meet the environmental objectives set out in Directive 2000/60/EC; |
| --- | --- |

(c)

the requirement to meet the environmental objectives set out in Directive 2000/60/EC;

| (d) | the requirement to prevent groundwater pollution in accordance with Directive 2006/118/EC; |
| --- | --- |

(d)

the requirement to prevent groundwater pollution in accordance with Directive 2006/118/EC;

| (e) | the requirement to meet the environmental quality standards for priority substances and certain other pollutants laid down in Directive 2008/105/EC; |
| --- | --- |

(e)

the requirement to meet the environmental quality standards for priority substances and certain other pollutants laid down in Directive 2008/105/EC;

| (f) | the requirement to meet the environmental quality standards for pollutants of national concern (i.e. river basin specific pollutants) laid down in Directive 2000/60/EC; |
| --- | --- |

(f)

the requirement to meet the environmental quality standards for pollutants of national concern (i.e. river basin specific pollutants) laid down in Directive 2000/60/EC;

| (g) | the requirement to meet the bathing water quality standards laid down in Directive 2006/7/EC; |
| --- | --- |

(g)

the requirement to meet the bathing water quality standards laid down in Directive 2006/7/EC;

| (h) | the requirements concerning the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture under Directive 86/278/EEC; |
| --- | --- |

(h)

the requirements concerning the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture under Directive 86/278/EEC;

| (i) | the requirements regarding hygiene of foodstuffs as laid down in Regulation (EC) No 852/2004 and the guidance provided in the Commission Notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene; |
| --- | --- |

(i)

the requirements regarding hygiene of foodstuffs as laid down in Regulation (EC) No 852/2004 and the guidance provided in the Commission Notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene;

| (j) | the requirements for feed hygiene laid down in Regulation (EC) No 183/2005. |
| --- | --- |

(j)

the requirements for feed hygiene laid down in Regulation (EC) No 183/2005.

| (k) | the requirement to comply with the relevant microbiological criteria set out in Regulation (EC) No 2073/2005; |
| --- | --- |

(k)

the requirement to comply with the relevant microbiological criteria set out in Regulation (EC) No 2073/2005;

| (l) | the requirements regarding maximum levels for certain contaminants in foodstuffs set out in Regulation (EC) No 1881/2006; |
| --- | --- |

(l)

the requirements regarding maximum levels for certain contaminants in foodstuffs set out in Regulation (EC) No 1881/2006;

| (m) | the requirements regarding maximum residue levels of pesticides in or on food and feed set out in Regulation (EC) No 396/2005; |
| --- | --- |

(m)

the requirements regarding maximum residue levels of pesticides in or on food and feed set out in Regulation (EC) No 396/2005;

| (n) | the requirements regarding animal health in Regulations (EC) No 1069/2009 and (EU) No 142/2011. |
| --- | --- |

(n)

the requirements regarding animal health in Regulations (EC) No 1069/2009 and (EU) No 142/2011.

(b)
     
  Conditions relating to the additional requirements [Am. 126]

| 5. | When necessary and appropriate to ensure sufficient

  adequate
  protection of the environment and human health, specify requirements for water quality and monitoring that are additional to and/or stricter than those specified in Annex I.

  Depending on the outcome of the risk assessment referred to in point 4, Such additional requirements may in particular concern:






  (a) | heavy metals; |
| --- | --- | --- |

5.

Depending on the outcome of the risk assessment referred to in point 4, Such additional requirements may in particular concern:

(a)

heavy metals;

| (b) | pesticides; |
| --- | --- |

(b)

pesticides;

| (c) | disinfection by-products; |
| --- | --- |

(c)

disinfection by-products;

| (d) | pharmaceuticals; |
| --- | --- |

(d)

pharmaceuticals;

| (da) | the presence of microplastics; |
| --- | --- |

(da)

the presence of microplastics;

| (e) | other substances of emerging concern

  pollutants that have emerged as significant from environmental and public health analyses carried out at local level
  ; |
| --- | --- |

(e)

other substances of emerging concern

  pollutants that have emerged as significant from environmental and public health analyses carried out at local level
  ;

| (f) | anti-microbial resistance. [Am. 127] |
| --- | --- |

(f)

anti-microbial resistance. [Am. 127]

(c)
     
  Preventive measures [Am. 128]

| 6. | Identify preventive measures that are already in place or that should be taken to limit risks so that all identified risks can be adequately managed.
  Such preventive measures may include:






  (a) | access control; |
| --- | --- | --- |

6.

Such preventive measures may include:

(a)

access control;

| (b) | additional disinfection or pollutants removal measures; |
| --- | --- |

(b)

additional disinfection or pollutants removal measures;

| (c) | specific irrigation technology mitigating the risk of aerosol formation (e.g. drip irrigation); |
| --- | --- |

(c)

specific irrigation technology mitigating the risk of aerosol formation (e.g. drip irrigation);

| (d) | pathogen die-off support before harvest; |
| --- | --- |

(d)

pathogen die-off support before harvest;

| (e) | establishment of minimum safety distances. |
| --- | --- |

(e)

establishment of minimum safety distances.

Specific preventive measures that may be relevant are set out in Table 1.

Table 1: Specific preventive measures

| Reclaimed


  water quality


  class | Specific preventive measures |
| --- | --- |
| A | — | Pigs must not be exposed to fodder irrigated with reclaimed water unless there is sufficient data to indicate that the risks for a specific case can be managed. |

Reclaimed

water quality

class

Specific preventive measures

A

—

Pigs must not be exposed to fodder irrigated with reclaimed water unless there is sufficient data to indicate that the risks for a specific case can be managed.

B

| — | Prohibition of harvesting of wet irrigated or dropped produce. |
| --- | --- |

—

Prohibition of harvesting of wet irrigated or dropped produce.

| — | Exclude lactating dairy cattle from pasture until pasture is dry. |
| --- | --- |

—

Exclude lactating dairy cattle from pasture until pasture is dry.

| — | Fodder has to be dried or ensiled before packaging. |
| --- | --- |

—

Fodder has to be dried or ensiled before packaging.

| — | Pigs must not be exposed to fodder irrigated with reclaimed water unless there is sufficient data to indicate that the risks for a specific case can be managed. |
| --- | --- |

—

Pigs must not be exposed to fodder irrigated with reclaimed water unless there is sufficient data to indicate that the risks for a specific case can be managed.

C

| — | Prohibition of harvesting of wet irrigated or dropped produce. |
| --- | --- |

—

Prohibition of harvesting of wet irrigated or dropped produce.

| — | Exclude grazing animals from pasture for five days after last irrigation. |
| --- | --- |

—

Exclude grazing animals from pasture for five days after last irrigation.

| — | Fodder has to be dried or ensiled before packaging. |
| --- | --- |

—

Fodder has to be dried or ensiled before packaging.

| — | Pigs must not be exposed to fodder irrigated with reclaimed water unless there is sufficient data to indicate that the risks for a specific case can be managed. |
| --- | --- |

—

Pigs must not be exposed to fodder irrigated with reclaimed water unless there is sufficient data to indicate that the risks for a specific case can be managed.

D

| — | Prohibition of harvesting of wet irrigated or dropped produce. |
| --- | --- |

—

Prohibition of harvesting of wet irrigated or dropped produce.

| 7. | Ensure that adequate quality control systems and procedures are in place, including monitoring of the reclaimed water for relevant parameters, and that adequate maintenance programmes for equipment are established. |
| --- | --- |

7.

| 8. | Ensure that environmental monitoring systems are in place that will detect any negative effects of the water reuse, as well as ensure that feedback from the monitoring is provided and that all processes and procedures are appropriately validated and documented.
  It is recommended that the reclamation plant operator set up and maintain a quality management system certified under ISO 9001 or equivalent. |
| --- | --- |

8.

It is recommended that the reclamation plant operator set up and maintain a quality management system certified under ISO 9001 or equivalent.

| 8a. | Ensure that the reclamation facility is equipped with an alternative means of discharging the treated waste water that is not reused. [Am. 129] |
| --- | --- |

8a.

| 9. | Ensure that an appropriate system is in place to manage incidents and emergencies, including procedures to inform all relevant parties appropriately such event, and keep a regularly updated emergency response plan. |
| --- | --- |

9.

| 9a. | Ensure that the reclaimed water distribution infrastructure is separate and constructed in such a manner that it avoids risks of contamination of the supply and distribution system for water intended for human consumption. [Am. 130] |
| --- | --- |

9a.

| 9b. | Ensure that the reclaimed water distribution infrastructure is appropriately marked, and, where it is constructed with open storm drains, that it is adequately equipped with sufficiently visible signage, including where waste water is mixed with water of other origins. [Am. 131] |
| --- | --- |

9b.

| 9c. | Ensure that coordination mechanisms are established amongst different actors to guarantee the safe production and use of reclaimed water. [Am. 132] |
| --- | --- |

9c.

---