Article 1 Subject matter and purpose
1. This Regulation lays down minimum requirements for water quality and monitoring and provisions on risk management, for the safe use of reclaimed water in the context of integrated water management. 2. The purpose of this Regulation is to guarantee that reclaimed water is safe for agricultural irrigation, thereby ensuring a high level of protection of the environment and of human and animal health, promoting the circular economy, supporting adaptation to climate change, and contributing to the objectives of Directive 2000/60/EC by addressing water scarcity and the resulting pressure on water resources, in a coordinated way throughout the Union, thus also contributing to the efficient functioning of the internal market.
Article 2 Scope
1. This Regulation applies whenever treated urban waste water is reused, in accordance with Article 12(1) of Directive 91/271/EEC, for agricultural irrigation as specified in Section 1 of Annex I to this Regulation. 2. A Member State may decide that it is not appropriate to reuse water for agricultural irrigation in one or more of its river basin districts or parts thereof, taking into account the following criteria: (a) the geographic and climatic conditions of the district or parts thereof; (b) the pressures on and the status of other water resources, including the quantitative status of groundwater bodies as referred to in Directive 2000/60/EC; (c) the pressures on and the status of the surface water bodies in which treated urban waste water is discharged; (d) the environmental and resource costs of reclaimed water and of other water resources. Any decision taken pursuant to the first subparagraph shall be duly justified on the basis of the criteria referred to in that subparagraph and submitted to the Commission. It shall be reviewed as necessary, in particular taking into account climate change projections and national climate change adaptation strategies, and at least every six years taking into account river basin management plans established pursuant to Directive 2000/60/EC. 3. By way of derogation from paragraph 1, research or pilot projects in relation to reclamation facilities may be exempted from this Regulation where the competent authority establishes that the following criteria are met: (a) the research or pilot project will not be carried out within a water body used for the abstraction of water intended for human consumption or a relevant safeguard zone designated pursuant to Directive 2000/60/EC; (b) the research or pilot project will be subject to appropriate monitoring. Any exemption pursuant to this paragraph shall be limited to a maximum period of five years. Crops resulting from a research or pilot project exempted pursuant to this paragraph shall not be placed on the market. 4. This Regulation applies without prejudice to Regulation (EC) No 852/2004 and does not preclude food business operators from obtaining the water quality required to comply with that Regulation by using, at a subsequent stage, several water treatment options alone or in combination with non-treatment options, or from using alternative water sources for agricultural irrigation.
Article 3 Definitions
For the purposes of this Regulation, the following definitions apply: (1) ‘competent authority’ means an authority or a body designated by a Member State to carry out its obligations under this Regulation regarding the granting of permits for the production or supply of reclaimed water, regarding exemptions for research or pilot projects and regarding compliance checks; (2) ‘end-user’ means a natural or legal person, whether a public or private entity, that uses reclaimed water for agricultural irrigation; (3) ‘urban waste water’ means urban waste water as defined in point (1) of Article 2 of Directive 91/271/EEC; (4) ‘reclaimed water’ means urban waste water that has been treated in compliance with the requirements set out in Directive 91/271/EEC and which results from further treatment in a reclamation facility in accordance with Section 2 of Annex I to this Regulation; (5) ‘reclamation facility’ means an urban waste water treatment plant or other facility that further treats urban waste water that complies with the requirements set out in Directive 91/271/EEC in order to produce water that is fit for a use specified in Section 1 of Annex I to this Regulation; (6) ‘reclamation facility operator’ means a natural or legal person, representing a private entity or a public authority, that operates or controls a reclamation facility; (7) ‘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 environment in general; (8) ‘risk’ means the likelihood of identified hazards causing harm in a specified timeframe, including the severity of the consequences; (9) ‘risk management’ means systematic management that consistently ensures that water reuse is safe in a specific context; (10) ‘preventive measure’ means an appropriate action or activity that can prevent or eliminate a health or environmental risk, or that can reduce such a risk to an acceptable level; (11) ‘point of compliance’ means the point where a reclamation facility operator delivers reclaimed water to the next actor in the chain; (12) ‘barrier’ is any means, including physical or process-related steps or conditions of use, that reduces or prevents a risk of human infection by preventing contact of reclaimed water with produce to be ingested and directly exposed persons, or other means that, for example, reduces the concentration of microorganisms in the reclaimed water or prevents their survival on the produce to be ingested; (13) ‘permit’ means a written authorisation issued by a competent authority to produce or supply reclaimed water for agricultural irrigation in accordance with this Regulation; (14) ‘responsible party’ means a party carrying out a role or activity in the water reuse system, including the reclamation facility operator, the urban waste water treatment plant operator where different from the reclamation facility operator, the relevant authority other than the designated competent authority, the reclaimed water distribution operator or the reclaimed water storage operator; (15) ‘water reuse system’ means the infrastructure and other technical elements necessary for producing, supplying and using reclaimed water; it comprises all the elements from the entry point of the urban waste water treatment plant to the point where reclaimed water is used for agricultural irrigation, including distribution and storage infrastructure, where relevant.
Article 4 Obligations of the reclamation facility operator and obligations regarding reclaimed water quality
1. The reclamation facility operator shall ensure that, at the point of compliance, reclaimed water intended for agricultural irrigation as specified in Section 1 of Annex I complies with the following: (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 (c) and (d) of Article 6(3), as regards water quality. Beyond the point of compliance, the quality of the water shall no longer be the responsibility of the reclamation facility operator. 2. In order to ensure compliance in accordance with paragraph 1, the reclamation facility operator shall monitor water quality in accordance with the following: (a) Section 2 of Annex I; (b) any additional conditions set by the competent authority in the relevant permit pursuant to points (c) and (d) of Article 6(3), as regards monitoring.
Article 5 Risk management
1. For the purpose of producing, supplying and using reclaimed water, the competent authority shall ensure that a water reuse risk management plan is established. One water reuse risk management plan may cover one or more water reuse systems. 2. The water reuse risk management plan shall be prepared by the reclamation facility operator, other responsible parties and end-users, as appropriate. The responsible parties preparing the water reuse risk management plan shall consult all other relevant responsible parties and end-users, as appropriate. 3. The water reuse risk management plan shall be based on all the key elements of risk management set out in Annex II. It shall identify the risk management responsibilities of the reclamation facility operator and other responsible parties. 4. The water reuse risk management plan shall in particular: (a) set out any necessary requirements for the reclamation facility operator, in addition to those specified in Annex I, in accordance with point (B) of Annex II to further mitigate any risks before the point of compliance; (b) identify hazards, risks and appropriate preventive and/or possible corrective measures in accordance with point (C) of Annex II; (c) identify additional barriers in the water reuse system and set out any additional requirements, which are necessary after the point of compliance to ensure that the water reuse system is safe, including conditions related to distribution, storage and use where relevant, and identify the parties responsible for meeting those requirements. 5. The Commission is empowered to adopt delegated acts in accordance with Article 13 amending this Regulation in order to adapt to technical and scientific progress the key elements of risk management set out in Annex II. The Commission is also empowered to adopt delegated acts in accordance with Article 13 supplementing this Regulation in order to lay down technical specifications of the key elements of risk management set out in Annex II.
Article 6 Reclaimed water permit obligations
1. The production and supply of reclaimed water intended for agricultural irrigation as specified in Section 1 of Annex I shall be subject to a permit. 2. The responsible parties in the water reuse system, including the end-user where relevant in accordance with national law, shall submit an application for a permit or for a modification of an existing permit to the competent authority of the Member State in which the reclamation facility operates or is planned to operate. 3. The permit shall set out the obligations of the reclamation facility operator and, where relevant, of any other responsible parties. The permit shall be based on the water reuse risk management plan and shall specify, inter alia, the following: (a) the reclaimed water quality class or classes and the agricultural use for which, in accordance with Annex I, the reclaimed water is permitted, the place of use, the reclamation facilities and the estimated yearly volume of the reclaimed water to be produced; (b) conditions in relation to the minimum requirements for water quality and monitoring set out in Section 2 of Annex I; (c) any conditions in relation to additional requirements for the reclamation facility operator, set out in the water reuse risk management plan; (d) any other conditions necessary to eliminate any unacceptable risks to the environment and to human and animal health so that any risks are of an acceptable level; (e) the validity period of the permit; (f) the point of compliance. 4. For the purpose of assessing an application, the competent authority shall consult and exchange relevant information with other relevant authorities, in particular the water and health authorities if different from the competent authority, and any other party which the competent authority considers relevant. 5. The competent authority shall decide without delay whether to grant a permit. Where, due to the complexity of an application, the competent authority needs more than 12 months from the receipt of a complete application to decide whether to grant a permit, it shall communicate the expected date of its decision to the applicant. 6. Permits shall be regularly reconsidered, and shall be updated where necessary, at least in the following cases: (a) there has been a substantial change in capacity; (b) equipment has been upgraded; (c) new equipment or processes have been added; or (d) there have been changes in climatic or other conditions which significantly affect the ecological status of surface water bodies. 7. Member States may require that storage, distribution and use of reclaimed water be subject to a specific permit in order to apply the additional requirements and barriers identified in the water reuse risk management plan as referred to in Article 5(4).
Article 7 Compliance check
1. The competent authority shall verify whether there is compliance with the conditions set out in the permit. Compliance checks shall be carried out through the following means: (a) on-the-spot checks; (b) monitoring data obtained in particular pursuant to this Regulation; (c) any other adequate means. 2. In the event of non-compliance with the conditions set out in the permit, the competent authority shall require the reclamation facility operator and, where relevant, the other responsible parties to take any necessary measures to restore compliance without delay and immediately inform the end-users affected. 3. Where non-compliance with the conditions set out in the permit represents a significant risk to the environment or to human or animal health, the reclamation facility operator or any other responsible parties shall immediately suspend supply of the reclaimed water until the competent authority determines that compliance has been restored, following procedures defined in the water reuse risk management plan, in accordance with point (a) of Section 2 of Annex I. 4. If an incident affecting compliance with the conditions set out in the permit occurs, the reclamation facility operator or any other responsible parties shall immediately inform the competent authority and other parties which could potentially be affected, and communicate to the competent authority the information necessary for assessing the impact of such an incident. 5. The competent authority shall regularly verify compliance by the responsible parties with the measures and tasks set out in the water reuse risk management plan.
Article 8 Cooperation between Member States
1. Where water reuse is of cross-border relevance, Member States shall designate a contact point for the purposes of cooperation with other Member States’ contact points and competent authorities, as appropriate, or shall use existing structures stemming from international agreements. The role of contact points or existing structures shall be to: (a) receive and transmit requests for assistance; (b) provide assistance upon request; and (c) coordinate communication between competent authorities. Before granting a permit, competent authorities shall exchange information on the conditions set out in Article 6(3) with the contact point in the Member State in which reclaimed water is intended to be used. 2. Member States shall respond to requests for assistance without undue delay.
Article 9 Information and awareness-raising
Savings of water resources as a result of water reuse shall be the subject of general awareness-raising campaigns in Member States where reclaimed water is used for agricultural irrigation. Such campaigns may include the promotion of the benefits of safe water reuse. Those Member States may also set up information campaigns for end-users to ensure the optimal and safe use of reclaimed water, thereby ensuring a high level of protection of the environment and of human and animal health. Member States may adapt such information and awareness-raising campaigns to the scale of water reuse.
Article 10 Information to the public
1. Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States in which reclaimed water is used for agricultural irrigation as specified in Section 1 of Annex I to this Regulation shall ensure that adequate and up-to-date information on water reuse is available to the public, online or by other means. That information shall include the following: (a) the quantity and the quality of the reclaimed water supplied in accordance with this Regulation; (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, where such data are available; (c) the permits granted or modified in accordance with this Regulation, including the conditions set by competent authorities in accordance with Article 6(3) of this Regulation; (d) the results of any compliance checks carried out in accordance with Article 7(1) of this Regulation; (e) the contact points designated in accordance with Article 8(1) of this Regulation. 2. The information referred to in paragraph 1 shall be updated every two years. 3. Member States shall ensure that any decision taken in accordance with Article 2(2) is made available to the public, online or by other means.
Article 11 Information relating to monitoring of implementation
1. Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States in which reclaimed water is used for agricultural irrigation as specified in Section 1 of Annex I to this Regulation, assisted by the European Environment Agency, shall: (a) set up and publish by 26 June 2026, and update every six years thereafter, a data set containing information on the outcome of the compliance check performed in accordance with Article 7(1) of this Regulation and other information to be made available to the public, online or by other means, in accordance with Article 10 of this Regulation; (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, which has been collected in accordance with Article 7(1) of this Regulation, and information on the measures taken in accordance with Article 7(2) and (3) of this Regulation. 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 sets referred to in paragraph 1, the European Environment Agency, in consultation with Member States, shall draw up, publish and update, on a regular basis or following a request from the Commission, a Union-wide overview. That overview 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 14. 5. By 26 June 2022, the Commission shall, in consultation with Member States, establish guidelines to support the application of this Regulation.
Article 12 Evaluation and review
1. The Commission shall, by 26 June 2028, carry out an evaluation of this Regulation. The evaluation shall be based on at least the following: (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); (c) relevant scientific, analytical and epidemiological data; (d) technical and scientific knowledge; (e) WHO recommendations, where available, or other international guidance or ISO standards. 2. In carrying out the evaluation, the Commission shall pay particular attention to the following aspects: (a) the minimum requirements set out in Annex I; (b) the key elements of risk management set out in Annex II; (c) the additional requirements set by competent authorities pursuant to points (c) and (d) of Article 6(3); (d) the impact of water reuse on the environment and on human and animal health, including the impact of substances of emerging concern. 3. As part of the evaluation, 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; (b) expanding the requirements of this Regulation to cover the indirect use of treated waste water. 4. Based on the results of the evaluation or whenever new technical and scientific knowledge so requires, the Commission may examine the need to review the minimum requirements set out in Section 2 of Annex I. 5. Where appropriate, the Commission shall submit a legislative proposal to amend this Regulation.
Article 13 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 5(5) shall be conferred on the Commission for a period of five years from 25 June 2020. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 5(5) 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 5(5) shall enter into force only if no objection has been expressed either by the European Parliament or 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 14 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. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 15 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 26 June 2024, notify the Commission of those rules and of those measures and shall notify it of any subsequent amendment affecting them.
Article 16 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 26 June 2023.