COMMISSION NOTICE

Guidelines to support the application of Regulation 2020/741 on minimum requirements for water reuse

(2022/C 298/01)

Table of contents

1. Introduction 3

2. General and administrative obligations 3

2.1. Scope 4

2.1.1. Criteria 4

2.1.2. Submitting and reviewing the decision 5

2.2. Competent authority 5

2.3. Contact points 6

2.4. Responsible parties 6

2.4.1. Responsibility of the reclamation facility operator for water quality 7

2.4.2. Responsibility of other actors 7

2.5. Permits 8

2.5.1. Authorities granting the permit 8

2.5.2. Permit application 9

2.5.3. Content of the permit 9

2.5.4. Exemptions for research and pilot projects 10

2.6. Compliance checks 10

2.7. Penalties 10

2.8. Awareness raising and information sharing 11

3. Technical aspects 12

3.1. Risk management 12

3.1.1. Key risk management elements 13

3.1.2. System description 15

3.1.3. Actors and roles 15

3.1.4. Hazard identification and environments and populations at risk 15

3.1.5. Environmental and health risk assessments methods 18

3.1.6. Conditions relating to the additional requirements 20

3.1.7. Preventive measures 20

3.1.8. Quality control and environmental monitoring systems 20

3.1.9. Emergency management and coordination 21

3.2. Types of crops and reclaimed water classes 21

3.2.1. Examples of irrigation methods and crop types 22

3.2.2. Examples of applying barriers to achieve the required water quality class 24

3.3. Validation monitoring 26

3.3.1. General principles 26

3.3.2. Validation monitoring protocols 27

3.3.3. Validation monitoring examples 28

3.3.4. Additional resources 29

1. Introduction

The EU’s water resources are increasingly coming under pressure. This is leading to water stress, when water resources are insufficient to meet the needs, and to a deterioration in water quality. In addition, climate change, unpredictable weather patterns and drought are contributing significantly to the strain on the availability of freshwater. Reusing reclaimed water is widely recognised as a practice that helps manage water resources more efficiently and helps adapt our systems to climate change, in line with the EU’s strategy set out in the European Green Deal (1).

Regulation (EU) 2020/741 of the European Parliament and of the Council on minimum requirements for water reuse (the Water Reuse Regulation) (2) seeks to facilitate and encourage the practice of reusing water for irrigation in agriculture, a sector that can be particularly vulnerable to scarce or intermittent water resources, making the EU food system more sustainable and resilient (3), while protecting public health and the environment.

The Water Reuse Regulation, applicable from 26 June 2023, sets uniform minimum water quality requirements for the safe reuse of treated urban waste water in agricultural irrigation. Harmonised minimum requirements will also ensure the single market for agricultural produce works properly and should boost consumer confidence.

Under this Regulation, urban waste water treated in line with the requirements of Directive 91/271/EEC governing urban waste water treatment (the Urban Waste Water Treatment Directive) (4), must undergo further treatment to meet the new minimum quality parameters and become suitable for use in agriculture.

In addition to the uniform minimum requirements for water quality, the Regulation also sets out uniform minimum monitoring requirements, risk management rules to assess and address potential additional health risks and environmental risks, permitting obligations, and rules on transparency, under which key information on all water reuse projects must be made publicly available.

Article 11(5) of the Water Reuse Regulation requires the Commission, in consultation with Member States, to draw up guidelines for applying the Regulation. This Notice sets out the guidelines. It has been prepared in close cooperation with the Working Group on Water Reuse (5) - established under the Strategic Coordination Group for Water Policy (6) - whose membership includes Member States authorities and stakeholder organisations. The Working Group on Water Reuse thoroughly discussed the document at two meetings on 21-22 October 2021 and 18 February 2022 and provided written comments.

Section 2 of these guidelines covers the general and administrative obligations set by the Regulation, including its scope. Section 3 covers the more technical aspects.

2. General and administrative obligations

This Section covers the following aspects: the scope of the Regulation, and in particular the application of Article 2(2); the competent authority(ies); the contact points and cross-border cooperation; the responsibilities of different actors; permits; compliance checks; penalties; awareness raising and information sharing.

2.1. Scope

The Regulation applies whenever treated urban waste water is reused for agricultural irrigation. However, according to Article 2(2), Member States may decide it is not appropriate to reuse water for agricultural irrigation in one or more of their river basin districts or in parts of them.

Article 2(2) decisions effectively ban water reuse in (part of) a territory and as a result, the Regulation does not apply in those areas. In other words, if a Member State considers the reuse of water inappropriate in only part of its territory, the Regulation would still apply in full in remaining areas where water can be reused.

Some of the more general obligations in the Regulation could still be applicable even if water reuse is banned throughout a Member State. For instance:

— Article 2(3) on exemptions for research projects: if a Member State allows such projects, it should designate the relevant competent authorities responsible for checking compliance with the criteria set out in Article 2(3);

— Article 8 on designating a contact point to cooperate with other Member States;

— Article 10(1) on informing the public about the contact point;

— Article 15 on penalties to ensure that, if a decision is taken not to allow water reuse, it is complied with, i.e. water is not reused and any exempt research projects meet the applicable conditions.

In the absence of an Article 2(2) decision, by the date the Regulation starts applying (26 June 2023), any responsible party in a water reuse system must be able to apply for a permit.

In other words, the default situation (in the absence of a national decision stating otherwise) is that water reuse is allowed subject to a permit granted under the Regulation. This means that the risk management plan must cover all possible risks and the project must be in full compliance with all EU health and environmental legislation.

2.1.1. Criteria

Many different circumstances and climatic characteristics in the Member States can influence a decision as to whether water reuse has a role to play in integrated water management.

It may be that certain Member States’ climatic conditions may render water reuse unnecessary and/or uneconomical, due to the abundance of rainfall. However, even Member States that face water shortages and recurring droughts may also have circumstances that mean that water reuse generally intended to address water scarcity may not be an appropriate practice.

This may be the case, for instance, if certain areas suffer long and prolonged droughts, and surface water bodies are dependent for their ecological flow and good water status on discharges of treated waste water. If treated waste water were to be redirected to a reclamation plant and subsequently to agriculture, this could deprive a surface water course of essential water volumes to guarantee minimum ecological flow.

In these cases, it is also necessary to assess the impact of using alternative sources, i.e. abstraction from (other) surface and/or groundwater bodies, as these may also have an impact on water quantity/quality. Pressure such as water abstraction might impact the quantitative status of groundwater bodies, in which case water reuse might offer an alternative water source. There may also be situations where there is no pressure from abstraction and the cost of reusing water might not be competitive with other water sources.

Any decision should therefore carefully weigh up the advantages and disadvantages of water reuse. All these considerations should feed into any decision not to reuse water in a given area as part of integrated water management.

Article 2(2) of the Regulation sets out the criteria that Member States must take into account to determine whether water reuse is not appropriate in certain river basin districts (or part(s) of them).

Member States taking any such decision under Article 2(2) of the Regulation must duly justify the decision and submit it to the Commission. If the ban is the result of pressure on the quality of surface water bodies that are dependent on the discharged waste water for their flow and ecological status, the decision would be duly justified providing it mentions:

— which bodies are affected;

— their current status:

— what other cost/effective measures have been taken and may be taken to close the gap to good status and/or avoid deterioration;

— the alternative sources of water for agricultural irrigation; and

— whether these other sources could result in over-abstraction from other surface or groundwater bodies, possibly affecting their quantitative or qualitative status.

If the decision is based on the criteria for cost effectiveness, it is important to take all costs into account, both environmental and resource costs (of the reclaimed water, and of the alternative source(s) that the Member State considered more appropriate). The economic analysis carried out under Article 5 of and Annex III to Directive 2000/60/EC Directive may provide useful background information.

2.1.2. Submitting and reviewing the decision

Any duly justified and clearly argued decision, based on the criteria set out in Article 2(2) of the Regulation, must be submitted to the Commission in writing, via the regular communication channels (e.g. via the Member State’s Permanent Representation to the EU). The Member State must also make any such decision available to the public, in accordance with Article 10(3).

Article 2(2) of the Regulation specifies that any such decision must be reviewed whenever necessary, to reflect changing circumstances. In particular, these decisions must be reviewed to take into account climate change projections and national climate change adaptation strategies (updated on a bi-annual basis) (7), and at least every six years, taking into account river basin management plans drawn up under Directive 2000/60/EC.

Any decision to ban water reuse should be therefore justified in the broader context of integrated water management. It should be fully compatible with the management approach set out in the relevant river basin management plans, as well as with climate mitigation and adaptation policies.

This means that the decision to ban water reuse must be based on information on water status, pressure and on the impacts and measures collected and set out in those plans. This would also entail making an assessment of the environmental and resource costs of reclaimed water and other water resources, also taking into account the economic analysis made under Article 5 of Directive 2000/60/EC.

2.2. Competent authority

Competent authorities referred to in Article 3(1) are responsible for:

— granting permits to produce and supply reclaimed water, including ensuring that a water reuse risk management plan is established;

— establishing whether the criteria for exempting research or pilot projects from the Regulation are met (where applicable);

— verifying compliance with the conditions set out in the permits and taking follow-up action in the event of breaches.

These responsibilities may entail, for example: reviewing the water reuse risk management plan and ensuring it covers all aspects; regularly verifying compliance with the measures and tasks in the plans; facilitating communication between different actors in a water reuse scheme; coordinating the exchange of information with other authorities. Depending on their administrative set-up, for example the structures used to manage river basins, Member States may decide to designate more than one competent authority.

If a Member State decides that it is not appropriate to produce and reuse reclaimed water for agricultural irrigation in any river basin district (effectively on its entire territory), in accordance with Article 2, setting up a competent authority would only be necessary if research and pilot projects on water reuse for agricultural irrigation were conducted. Similarly, if a Member State authorises the production of reclaimed water but not its use, a competent authority would also be required to manage permits for production.

2.3. Contact points

Article 8 of the Regulation requires Member States to designate a contact point for cooperation with other Member States’ contact points.

The role of the contact points is to: (a) receive and send requests for assistance; (b) provide assistance upon request; and (c) coordinate communication between competent authorities in different Member States. For example, before granting a permit to produce or supply reclaimed water, competent authorities must exchange information on the conditions set out in the related permit and risk management plans with the contact point in the Member State where reclaimed water is intended to be used. The contact points should respond to requests for assistance without undue delay.

It may not be necessary to create contact points if a Member State decides, on the basis of Article 2(2), that it is not appropriate to use reclaimed water for agricultural irrigation in any river basin district (effectively on its entire territory).

However, if a Member State does not authorise reclaimed water to be used on its territory, but exports reclaimed water to a neighbouring country, it must still have a contact point. Similarly, a contact point is needed in Member States that do not produce reclaimed water on their territory, but wish to import it, for use in irrigation, from a neighbouring country.

In addition, projects carried out in a neighbouring Member State may in some way affect a shared water catchment area and therefore require consultation between Member State competent authorities via the contact points.

2.4. Responsible parties

The Regulation identifies a series of ‘responsible parties’, i.e. actors carrying out a role or activity in a water reuse system. The water reuse system, as defined in Article 3(15), comprises the infrastructure and other technical parts, from the point of entry into 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 3(14) specifies that the responsible parties include:

— the reclamation facility operator;

— the urban waste water treatment plant operator, if this is different from the reclamation facility operator;

— the relevant authorities, other than the designated competent authority; and

— the reclaimed water distribution operator or the reclaimed water storage operator, where relevant.

The Regulation describes the minimum responsibilities for the reclamation facility operator (see Section 2.4.1).

The permit issued by the competent authority will set out the responsibilities for the other responsible parties, taking into account the responsibilities identified in the risk management plan.

The roles of other authorities, different from the competent authority, could include reviewing the risk management plans to verify compliance with the applicable regulations (e.g. on health, the environment, agriculture), setting specific requirements in their domain of expertise and issuing an opinion on the risk management plan.

The Member States may, where relevant, and in accordance with national laws, further define roles and responsibilities, provided they comply with the minimum rules.

2.4.1. Responsibility of the reclamation facility operator for water quality

The reclamation facility operator operates or manages a reclamation facility and it may be a private or a public body. It may be a different entity to the operator of the urban waste water treatment plant under the Urban Waste Water Treatment Directive.

Article 4(1) of the Regulation clarifies that the reclamation facility operator is responsible for the quality of the reclaimed water at the point of compliance.

The point of compliance is, as defined in Article 3(11), the point where the reclamation facility operator delivers the reclaimed water to the next actor in the chain. Depending on the specific set-up of a water reuse system in a Member State, the next actor may be the end user, or, if water is transported, distributed or stored for future use, it could be other actors.

At the point of compliance, which will be specified in the permit for producing and supplying reclaimed water (see Section 2.5 on permits), the reclamation facility operator must ensure that the reclaimed water meets the minimum requirements set out in Annex I as well as any other additional relevant condition set by the competent authority in the related permit, and as described in the risk management plan.

2.4.2. Responsibility of other actors

After the point of compliance, responsibility for water quality passes to the next actor in the chain, either the end user or any intermediate actor in charge of distribution or storage.

The risk management plan must set out the conditions related to distribution, storage and use, where relevant, and identify which parties in the water reuse system are responsible for meeting those requirements.

Where the risk management plan sets conditions of use for the end user, these must comply with EU food (and feed) hygiene legislation and related documents, in particular those mentioned in the Water Reuse Regulation. These include:

— Regulation (EC) No 178/2002 (8): the ‘General food law’, which lays down (in Article 17) the primary responsibility of all food business operators (including primary producers, i.e. farmers).

— Regulation (EC) No 852/2004 (9) on food hygiene: Article 4(1) repeats the responsibility of primary producers to comply with general hygiene provisions (good hygiene practices) laid down in Annex I to that Regulation. Annex I, Part A, II 5(c) states that food business operators producing or harvesting plant products must take adequate measures, and use potable water, or clean water, as appropriate, whenever necessary to prevent contamination.

— Regulation (EC) 2073/2005 (10) laying down microbiological criteria for foodstuffs, which includes E. coli criteria in certain food of non-animal origin (post-harvest).

— Regulation (EU) 2017/625 (11) (replacing Regulation (EC) No 882/2004) providing a legal framework for official controls on food and food safety at any stage of production, processing and distribution. Competent authorities must enforce and verify that the food business operator meets the food safety requirements.

— Commission Notice issuing guidance on addressing microbiological risks in fresh fruit and vegetables at primary production through food hygiene (12).

The Water Reuse Regulation, which defines water quality for a specific water source at a stage before primary production (before it is used for irrigation), complements the food hygiene rules. The food (and feed) hygiene rules apply from the stage of primary production, including irrigation, and cover all aspects of irrigation, for all sources of water.

2.5. Permits

Article 6(1) of the Regulation requires that the production and supply of reclaimed water for agricultural irrigation be subject to a permit. All permits must be based on the water reuse risk management plan and must set out the obligations of the reclamation facility operator and, where relevant, of any other responsible parties, in accordance with Article 6(3).

The Regulation describes the information that permits must cover, but it is up to the Member States to specify the details of the procedures for granting permits, such as the designation of the competent authorities and deadlines.

Therefore this Section does not cover issues related to the procedure, except to say that the Regulation explicitly allows Member States to apply existing procedures for granting permits, provided these are adapted to meet the requirements laid down in the Regulation.

2.5.1. Authorities granting the permit

Water reuse permits can only be granted by the competent authorities designated by the Member States. There should be no conflict of interest between the parties responsible for drawing up the draft water reuse risk management plan and the permit application, and the authority that grants the permit to produce and supply reclaimed water.

For the purpose of assessing an application, the competent authority must consult and exchange information with any other relevant authorities, in particular the water and health authorities (if different from the competent authority) and any other party the competent authority deems relevant.

Examples

Several different set-ups are possible at national level, as illustrated by the examples below.

Example 1 – If the reclamation plant, and thus its operator, is the same as the urban waste water treatment plant, the competent authority could be the urban waste water treatment permitting authority, and thus might be different from the water or health authorities.

In these cases, close cooperation between the different authorities is needed to ensure (i) the applicable water standards are complied with and maximum levels are not exceeded when reduced volumes of water are discharged into a surface water body, and (ii) the health standards are complied with when the water is used for irrigation.

In these cases, the water or health authorities can provide input into the process of preparing the risk management plan and the permit application, since there would be no conflict of interest with the authority granting the permit.

Example 2 – If the reclamation plant, and thus its operator, is different from the urban waste water treatment plant, the competent authority for the water reuse permit might be different from the permitting authority for the urban waste water treatment plant.

It could, for example, be the water or health authorities. In that case, these authorities cannot be involved in drafting the application for the permit or the risk management plan, since this would be a conflict of interest between the permitting authority and the parties drafting the permit application and risk management plan.

Nevertheless, these authorities could be asked to provide data or other information as input to the process, such as water resource monitoring data or other environmental data, providing guidance on the procedures to be followed or similar.

Example 3 – If the reclamation plant is owned by the competent authority, procedures should be in place to avoid conflicts of interest, ensure that the permit application and risk management plan are prepared by all responsible parties as appropriate, and that there is no interference with the person or division in charge of granting the permit.

If all requirements for the permit are met, the competent authority in the Member State should (in accordance with Article 6(5)) grant a permit containing all the necessary conditions and measures set out in the water reuse risk management plan, and without undue delay. This is to ensure regulatory certainty for all parties involved.

If, due to the complexity of an application, the competent authority needs more than 12 months from the date it received a complete application to decide whether to grant a permit, it must communicate the expected date of its decision to the applicant(s).

2.5.2. Permit application

Under Article 6(2), any responsible party in the water reuse system, including the end user where relevant in accordance with national law, can apply for a permit, or for changes to an existing permit. They must submit their application to the competent authority of the Member State in which the reclamation facility operates or is planned to operate.

In some water reuse projects, the reclamation plant operator transfers the reclaimed water directly to the end user. In other projects, however, other parties come into play and there may be a need for a reclaimed water distribution operator and a reclaimed water storage operator.

In these cases, Member States may choose to require such operators and end users to have a specific permit, in accordance with Article 6(7). These specific permits must then set out the obligations, including any additional requirements and barriers identified in the water reuse risk management plan developed for that scheme, as referred to in Article 5(4).

2.5.3. Content of the permit

As set out in Article 6(3), the permit – or permits, where responsible parties other than the reclamation plant operator are required to have a specific permit (Article 6(7)) – must be based on the water reuse risk management plan.

The water reuse risk management plan must be drawn up in line with Annex II to the Regulation. It must set out the conditions to meet to ensure compliance with the water quality, use and monitoring requirements in Annex I to the Regulation.

The permit must specify:

— The reclaimed water quality class(es) and the agricultural use for which the reclaimed water is permitted.

— The place or places where use is authorised.

— The reclamation facilities, including for example the location of the facility(ies), contact details of the operator, and the estimated yearly volume of reclaimed water to be produced.

— Conditions on the minimum requirements for water quality and monitoring set out in Section 2 of Annex I, which could include specifications about the type of treatment.

— Any conditions in relation to additional requirements for the reclamation facility operator, as set out in the water reuse risk management plan.

— Any other conditions necessary to eliminate any unacceptable risks to the environment or to human and animal health. These could include information on the exact role, tasks, activities and responsibilities of the other responsible parties in the system; or obligations related to environmental monitoring systems, depending on the outcomes of the risk management plan, and follow-up procedures if negative environmental consequences arise.

— The validity period of the permit.

— The point of compliance where checks will be carried out to verify that the operator has met its obligations as regards the quality of the reclaimed water.

As set out in Article 6(6), permits must be regularly reviewed and updated whenever necessary. Permits must be reviewed and updated at least when the following changes arise:

— a substantial change in the plant’s capacity;

— equipment is upgraded or new equipment or processes added, resulting in the need for validation monitoring before operation (for class A water);

— changes in climatic or other conditions that have a significant effect on the ecological status of surface water bodies.

2.5.4. Exemptions for research and pilot projects

Under Article 2(1), the Regulation applies whenever reclaimed water is used for agricultural irrigation. However, under Article 2(3) research or pilot projects can be exempted from this rule, if certain conditions are met. The competent authority must ascertain that the following criteria are met in order to grant this exemption:

— 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 inside a safeguard zone designated under Directive 2000/60/EC;

— the research or pilot project will be subject to appropriate monitoring.

It is for the competent authority to set the monitoring conditions and frequencies, on a case-by-case basis, needed to ensure compliance with the Water Framework Directive and other applicable legislation.

Exemptions may not last longer than five years. In addition, no crops grown in a research or pilot project exempted from this Regulation can be placed on the market.

2.6. Compliance checks

Compliance checks need to be performed by the competent authorities to ensure that the requirements set out in the permits are met by the different parties to the water reuse system.

These requirements may be for the reclamation plant operator, at the point of compliance, or for any other responsible parties or end users, according to the water reuse risk management plan.

If these players operate in different Member States – for example in a cross-border project as described in Section 2.3 – the competent authorities with jurisdiction for the relevant players need to perform these checks.

2.7. Penalties

In accordance with Article 15, Member States have to lay down the rules on penalties applicable to infringements of this Regulation and should take all measures necessary to ensure that they are implemented. The penalties should be effective, proportionate and dissuasive.

The following criteria could be taken into account when setting penalties:

a) the nature, gravity, extent and duration of the infringement;

b) the intentional or negligent character of the infringement;

c) the areas affected by the infringement, in particular sensitive areas;

d) the benefits derived from the infringement by those responsible (to ensure that those responsible are deprived of those benefits);

e) the repetitive character of the infringement (to discourage further offences of the same kind).

Member States should put in place compliance assurance measures to prevent and detect infringements and apply the penalties. Compliance assurance includes all the ways in which public authorities intervene to ensure that businesses and others (‘duty-holders’) comply with their environmental obligations including, for example, inspections and enforcement measures.

Broadly three categories of action could be considered:

— compliance monitoring: this means analysis, assessments, surveillance, inspections, investigations, audits or other checks and interventions carried out by, on behalf of, or under the supervision of a competent authority, to examine whether duty-holders are complying with enforceable obligations;

— follow-up and enforcement: this means action by a competent authority under administrative, civil or criminal law in response to non-compliance or suspected non-compliance with an enforceable obligation; and

— compliance promotion and prevention of non-compliance: this means action to encourage compliance with enforceable obligations other than by means of compliance monitoring or follow-up and enforcement.

This rule applies to all aspects of the Regulation, including the rules that Member States may decide to introduce regarding areas of their territories where water reuse is not considered appropriate or regarding scientific or pilot research projects.

2.8. Awareness raising and information sharing

According to Article 9, Member States who practice water reuse for agricultural irrigation are required to organise general awareness-raising campaigns, which could include promoting the benefits of safe water reuse.

Member States are free to adapt the extent and tone of such campaigns to their specific circumstances, including to the scale of water reuse. They may also set up specific information campaigns for end users, to encourage, where appropriate, the use of reclaimed water as a safe and sustainable alternative for irrigation and ensure its optimal and safe use, giving a high level of protection to the environment and human and animal health.

Such information campaigns can be useful for addressing possible public concerns about water reuse and can help ensure broad support for setting up a water reuse scheme. In this context, to create trust and acceptance, it is recommended to involve stakeholders early and carefully tailor messages, tapping into personal experiences and addressing location-specific challenges.

Good practice suggests that multiple levels of public and stakeholder participation can be effective in reaching a wide audience, ranging from targeted awareness-raising campaigns through to consultation and higher levels of stakeholder involvement in planning and decision-making.

As a general indication, the 2016 ‘CIS Guidelines on integrating water reuse into water planning and management in the context of the Water Framework Directive’ (13) suggest gathering the following information as input to information and awareness campaigns:

— the justification of the need for water reuse, e.g. the context of water scarcity, including under future climate conditions;

— the costs of installing treatment and distribution systems;

— the environmental benefits and drawbacks/risks;

— the social and economic benefits and drawbacks/risks: transparency about exposure risks to the public, how these will be addressed and the applicable standards of treatment.

It is also important to take into account the cost of crop losses due to the lack of water for irrigation, which could be minimised by using a reliable and more predictable water source, such as reclaimed water.

Article 10 and 11 of the Regulation set out rules regarding information to be made available to the public and information on how the rules are implemented. This information must be accessible to the European Commission, the European Environment Agency and the European Centre for Diseases Prevention and Control.

Information that has to be made regularly available to the public includes:

— the quantity and quality of reclaimed water supplied;

— the percentage of the total amount of treated urban waste water that the reclaimed water represents, where this data is available;

— the results of compliance checks;

— the designated contact points; and

— any Article 2(2) decision.

Furthermore, Member States will have to publish datasets with additional information on the outcome of compliance checks, as well as additional information on cases of non-compliance, including on measures taken to restore compliance.

Member States may choose the most appropriate format and means of sharing Article 10 information with the public, adapted to their own specific circumstances.

Regarding Article 11, which details the information on implementation that the Member States have to make available, the format and presentation of this data may be set out in implementing acts that the Commission may develop, assisted by the Committee established by Directive 2000/60/EC and in accordance with the procedure detailed in Article 14.

3. Technical aspects

This Section addresses: all aspects related to risk management; types of crops and reclaimed water classes; and validation monitoring.

3.1. Risk management

As set out in Article 5(1) of the Regulation, the competent authority is ultimately responsible for making sure that a risk management plan is established that addresses all possible aspects of a water reuse project, including the production, supply and use of reclaimed water, and which assigns responsibility for each aspect of the management of a reuse project.

While the competent authority is responsible for making sure a risk management plan is established, the parties who must actually draw up the plan are the reclamation facility operator, other responsible parties and end users, as appropriate.

The person/persons/entity who actually develop and draft the risk management plan can be any of the ‘responsible parties’ involved in a water reuse system or the end user, in accordance with national legislation. For the purpose of correctly implementing the Regulation it does not matter who is actually preparing or compiling the plan, as long as all relevant responsible parties and end users are consulted as appropriate and required by the nature, location and characteristics of the water reuse scheme.

The risk management plan can cover one or more water reuse systems, provided it specifically addresses all aspects required by the Regulation. This could lead to a system in which a number of standard basic elements are established - for example in cases with similar crops and irrigation practices in the area served or in a code of good practice – that can form the basis of a more tailored risk management plan for specific water reuse systems.

The aspects that the risk management plan has to address (as required by the Regulation) consist of any additional requirements for the plant operator, to be met before the water is delivered to the next actor in the chain. And appropriate preventive/corrective measures and barriers, monitoring or any other requirement to be applied in the water reuse system, to ensure its safety, after the point of compliance, by other players in the system.

The risk management plan describes the tasks and requirements, and clearly identifies the responsibilities of the relevant actors in the scheme.

There may be cases where a specific end user has not yet been identified. In such cases the risk management plan could be developed on the basis of the intended use of reclaimed water in the specific area (e.g. based on most common agriculture practices and crops).

When a new end user is identified after the risk management plan is finalised, an evaluation should be carried out to establish whether adaptations to the plan are necessary: for example, the new end user’s irrigation practice and crops might differ from those already served by the reclamation facility plant (requiring, for example, a higher class of water quality).

In this case, the risk management plan might require any risks, preventive measures or barriers for the new uses to be reassessed. This might require some adaptations in the water reuse scheme (as well as adaptations to the permit, which is based on the risk management plan, where relevant). This re-assessment could be done by any of the responsible parties or the end user, as appropriate.

3.1.1. Key risk management elements

The risk management plan must be based on the elements of risk management listed in Annex II of the Regulation. It must follow a systematic approach that includes carrying out a structured analysis of the water reuse system, identifying potential hazards and hazardous events (along with the populations and environments at risk and the related exposure routes), and planning, where appropriate, possible preventive measures and barriers to manage and mitigate the assessed risks.

It should also include provisions for communication and cooperation among the parties involved, to ensure that corrective action is taken and notified where required. The key elements of the risk management plan (KRMs) are the basis for ensuring that the reclaimed water is used and managed safely to protect human and animal health and the environment.

Annex II of the Regulation identifies 11 key elements (KRMs), divided into Parts A, B and C and constituting the basis of the suggested overall approach for a risk management plan.

These are:

Part (A) – Key elements of risk management 1. System description (KRM1) – describe the entire water reuse system, from the entry point to the urban waste water treatment plant, to the point of use. 2. Actors and roles (KRM2) – identify all the parties involved in the water reuse system, along with their roles and responsibilities. 3. Hazard identification (KRM3) – identify potential hazards (pathogens and pollutants) and hazardous events (e.g. treatment failures) associated with the water reuse system. 4. Environments and populations at risk and exposure routes (KRM4) - identify populations and environments potentially exposed to each identified hazard. 5. Environmental and health risk assessments (KRM5) – for each previously identified hazard, identify potential associated risks for each receptor (people, animals, crops or plants, other terrestrial biota, aquatic biota, soils or the environment in general), for each exposure route. Risk assessment may be conducted with qualitative and semi-quantitative methods; quantitative risk assessment would require sufficient supporting data. This risk assessment should also take into account any obligations and requirements set out by the EU legislation indicated in the Regulation, as well as any relevant national or local legislation.

Part (B) – Conditions relating to the additional requirements 6. Additional requirements (KRM6) - the outcomes of the risk assessment might identify additional or stricter water quality and monitoring requirements than those from Section 2 of Annex I of the Regulation. If additional parameters or limits are included, this should be based on the outcomes of the risk assessment and supported by scientific evidence that they originate from the water reuse system and not from other sources. These additional parameters may also include the following pollutants: heavy metals, pesticides, disinfection by-products, pharmaceuticals, substances of emerging concern, bacteria that exhibit anti-microbial resistance.

Part (C) - Preventive measures 7. Preventive measures (KRM7) – identify preventive measures or barriers (additional or already in place) that should be applied to parts of the water reuse system, to limit or mitigate any identified risk. For example, access control methods, additional water treatments or specific irrigation technologies or barriers. 8. Quality control systems (KRM8) – determine quality control measures, including protocols for monitoring the reclaimed water for the relevant parameters and maintenance programmes for the equipment, to ensure the effectiveness of the treatment chain and the preventive measures adopted. 9. Environmental monitoring system (KRM9) - set up an environmental monitoring system to control the release of the identified pollutants in the exposed environmental receptors (e.g. freshwater, groundwater, soil). The monitoring system could include documented procedures already in place to ensure ongoing environmental protection, where appropriate, or these could be further developed or tailored, depending on the results of the environmental risk assessment. 10. Emergency management (KRM10) - set up protocols to manage incidents and emergencies. 11. Coordination (KRM11) – determine coordination and communication mechanisms between the different actors involved in the water reuse system.

One possible structure to help organise the analysis of the KRM elements is described in the Joint Research Centre (JRC) technical report ‘Technical Guidance – Water Reuse Risk Management for Agricultural Irrigation Schemes in Europe’ (14). This JRC report proposes a modular structure (see Figure 1), whereby each module addresses a specific aspect of a risk management plan and includes several of the KRMs:

— Module I - Preparation (KRMs 1 and 2);

— Module II - Risk Assessment (KRMs 3, 4, 5 and 6);

— Module III - Monitoring (KRMs 6 and 9);

— Module IV - Governance, Management and Communication (KRMs 7, 8, 9, 10 and 11).

Figure 1

Water reuse key risk management elements (KRMs) organised into four modules, to aid the formulation of a risk management plan

3.1.2. System description

A detailed description of the system (KRM1) is the starting point for completely characterising the entire water reuse system - from the inlet point for the raw waste water into the urban waste water treatment plant (UWWTP), to the final uses of reclaimed water. It should include a detailed description of the UWWTP and/or the reclamation facility, any infrastructure related to pumping, storage and distribution, irrigation systems, and final uses, within the identified system boundaries (see example in Figure 2).

To collect the data necessary for the risk assessment, the system description should also include a characterisation of the water quality for the sources of waste water entering the UWWTP, water volume data, any variability and weather events, and a description of the surrounding environmental matrices (soil, groundwater and surface water, ecosystems).

Figure 2

Main elements of a water reuse system, identifying receptors in the risk assessment

3.1.3. Actors and roles

All the actors involved and their roles and responsibilities should be identified for each element of the water reuse system (KRM2).

This should include, the actors responsible for (i) operating the plants (UWWTP and reclamation facility operators), (ii) transport and storage, where relevant, and (iii) the irrigated fields (farmers). It should also include any relevant authorities or bodies (e.g. water authorities, public health authorities, environmental authorities), or other parties such as associations of farmers and consortia of irrigators.

3.1.4. Hazard identification and environments and populations at risk

Elements KRM3 and KRM4 include:

1. Identifying any potential hazards (pollutants and pathogens) or hazardous events (failure of treatments, accidental leakages, contamination) that originate from the water reuse system and might pose a risk to public health and/or the environment;

2. Characterising potential exposure routes for each hazard to the identified human, animal or environmental receptors (populations and environments exposed). These elements are needed to be able to subsequently assess the health and environmental risks (KRM5).

The identification of hazards (KRM3) should include any pathogens and pollutants in the reclaimed water that might pose a risk to the human and animal health and the environment.

Microbial pathogens in reclaimed water (e.g. E. coli and other bacteria, viruses, parasites) used for agricultural irrigation could be responsible for water-borne disease outbreaks (e.g. gastroenteritis) and other acute effects (15).

Chemical pollutants that could be still present in reclaimed water might also pose a risk to human health. However, chemical contaminants are usually present at low concentrations in UWWTP effluents from domestic waste water, and generally require a longer exposure to cause illnesses or acute reactions, so overall the risk from these pollutants is lower than that posed by pathogens.

It is important to identify any industries located in the area served by the UWWTP whose discharges into the urban collection system might contribute to high concentrations of specific chemical pollutants in the urban waste water (e.g. pharmaceutical industries, galvanisation industries).

Uncontrolled concentrations of chemical hazards in UWWTP effluents might occur as a result of hazardous events, like accidental or inappropriate discharges. The likelihood of these can be minimised by appropriate preventive measures (16).

Full compliance of the reclaimed water with any legislation applicable to the water reuse system, regulating both microbiological and chemical pollutants, along with the requirements for agricultural irrigation set by the hygiene of feed and foodstuff legislations, would ensure the protection of the environment, as well as human and animal health.

The risk management system should ensure, therefore, that the use of reclaimed water does not lead to a harmful concentration of contaminants in a specific environmental matrix (e.g. groundwater) and that appropriate preventive measures are taken to prevent this (e.g. by appropriate treatments to reduce pollutants within set-up limits, by minimising any accidental release to the surroundings).

Along with the characterisation of the reclaimed water, an initial screening list of relevant hazards (pathogens and chemical pollutants) might be identified by also taking into account all the relevant EU, national and local legislation, as well as the requirements in the legislation (listed in Annex II point 5 of the Regulation) on protecting surface and groundwater resources. This legislation includes: the Water Framework Directive (WFD) 2000/60/EC, the Groundwater Directive (GWD) 2006/118/EC, the Environmental Quality Standards Directive (EQSD) 2008/105/EC, the Nitrates Directive (ND) Directive 91/676/EEC and, where applicable, the Bathing Water Directive (BWD) 2006/7/EC and Drinking Water Directive (DWD) 2020/2184.

The requirements that the reclaimed water should comply with will depend on the site-specific conditions for the water reuse system and the assessment of how the use of reclaimed water for agricultural irrigation may affect the surrounding environment through potential pathways (e.g. irrigational water run-off, infiltration into groundwater, etc.).

In particular, if reclaimed water were to migrate towards water bodies (surface or groundwater) in the area covered by the water reuse system, the assessment should consider whether the receiving water bodies would still meet the environmental objectives of Article 4 of the WFD (i.e. good surface water ecological and chemical status and good groundwater chemical status – with chemical status being further specified in the EQSD and GWD).

Good ecological and chemical status for surface water imply compliance with EU and national environmental quality standards (EQS). EU environmental quality standards are set under the EQS Directive, whereas national standards may address pollutants of national concern, namely River Basin Specific Pollutants, which are part of good surface ecological status.

The EQS Directive also provides for a ‘Watch List’ mechanism to collect monitoring data at EU-level on pollutants of emerging concern and substances that may pose a risk to or via the aquatic environment, and for which data on risk are insufficient to set an environmental quality standard.

The chemical status of freshwaters identified by Member States within their river basin management plans can be consulted via the WISE system (17).

Further information on environmental quality standards for priority substances can be consulted via the ECHA database (18).

Relevant information on emissions of specific pollutants can be found in the European Pollutant Release and Transfer Register (applicable to UWWTP with a capacity of 100 000 P.E.) (19).

Other site-specific conditions for protecting surface water and groundwater may also apply: for example, if the water reuse system and the irrigated areas are located near a Nitrate Vulnerable Zone designated under the Nitrates Directive.

Although water reuse in agriculture could be a way of recovering nutrients for irrigation, careful consideration should be given to avoiding nitrates pollution in water resources, by reducing the nitrate content in the reclaimed water below harmful levels.

Similarly, if the reclaimed water is likely to migrate to water bodies classified as Drinking Water Protected Areas (DWPAs), it is important to (i) identify any risks of contamination for drinking water sources from regulated pollutants present in the reclaimed water and (ii) plan any treatments needed to reduce them to acceptable levels.

Furthermore, if reclaimed water runs off to surface waters used for recreational bathing activities, additional requirements for pathogens, deriving from the Bathing Water Directive, may be included. These laws aim to protect the environment and human health by setting standards and/or monitoring obligations for pathogens or chemicals, including heavy metals, disinfection by-products, pharmaceuticals and other substances classified as priority pollutants.

Because reclaimed water is used for agricultural irrigation, the Regulation identifies additional legislation in Annex II point 5 that protects food and feed, soil, crops, and animals. The relevance of the requirements in this legislation to a specific water reuse system will depend on the types of cultivation (e.g. production of foodstuff or feedstuff) and practices (e.g. use of pesticides, use of sewage sludge) on the agricultural field irrigated with reclaimed water.

These requirements include: requirements on the hygiene of foodstuff (Regulation (EC) No 852/2004), feed hygiene (Regulation (EC) No 183/2005), microbiological criteria (Regulation (EC) No 2073/200), maximum contaminants in foodstuff (Regulation (EC) No 1881/2006), levels of pesticides in food and feed (Regulation (EC) No 396/2005), use of sewage sludge (Directive 86/278/EEC), and the protection of animal health (Regulations (EC) No 1069/2009 and (EU) No 142/2011).

Figure 3 shows a graphical example of how to determine which directive or regulation applies to a water reuse system, assuming potential pathways of the reclaimed water to the environmental matrices (freshwater resources) due to accidental leakages or via run-off from the irrigated field.

The figure also illustrates the regulations and directive listed at point 5 of Annex II that might apply, depending on the agricultural practices. A table identifying the applicability of these requirements to a water reuse system is also presented in Annex 2 to this Notice.

Figure 3

Example of (i) how to identify applicable directives and regulations in a water reuse system, based on potential pathways taken by reclaimed water to the surrounding environments (surface water and groundwater) and (ii) regulations and directives that could apply to agricultural irrigation, depending on specific agricultural practices

Other specific aspects linked to the effect of reclaimed water quality parameters on agronomic characteristics, including hazards on soil and crops/plants, should also be considered. According to ISO 16075-1:2020, agronomic hazards from reclaimed water that could damage soil and irrigated crops are: (i) chemical substances, such as salinity, boron, specific ion toxicity; (ii) other chemical elements; and (iii) nutrients.

Pathogens that could cause disease to plants or crops are not usually found in reclaimed water from UWWTP effluents. However, their presence in reclaimed water could be assessed in site-specific conditions (e.g. run-off of irrigation water infected with plant pathogens).

Annex 2 of this Notice contains informative examples and tables for pathogens and pollutants typically present in UWWTP effluents and regulated by some of the above-mentioned directives and regulations, as well as examples of agronomic hazards that could affect soils, crops, freshwater and groundwater during agricultural irrigation.

It also contains examples of hazardous events and exposure routes for health and environmental risk assessment, and examples of populations and environments at risk.

Note, however, that the lists of resources in the Annex are not to be considered exhaustive and are proposed purely for information. The hazards should be accurately identified for each specific water reuse system, considering the characterisation of the reclaimed water and any applicable requirements.

Some other pollutants that are not yet regulated and cannot be found in the listed directives and regulations (e.g. micro-plastics or some compounds of emerging concern) could be added to the list of hazards, if the risk to human and animal health or the environment is supported by scientific evidence and it is proven that these contaminants originate from the water reuse system and not from other sources. The risk assessment could also identify the source of these contaminants, e.g. due to the presence of particular industries, and plan any preventive measures.

3.1.5. Environmental and health risk assessments methods

Environmental and health risk assessment (KRM5) should be conducted by taking into account previously identified hazards (individually or in groups) and hazardous events, potential routes of exposure and the receptors identified within the water reuse system.

Risk assessment may be conducted by qualitative or semi-quantitative methods. Qualitative risk assessment is suggested as the most appropriate and economically-feasible methodology. Quantitative risk assessment could be used for projects with high risk and when enough supporting data are available for their implementation.

As regards methodologies, qualitative, semi-quantitative and quantitative methodologies can be used for these assessments. The health risk assessment evaluates any risk to human and animal health, whereas the environmental risk assessment aims to determine if the identified contaminants in the reclaimed water affect the quality status of environmental matrices.

Qualitative and semi-quantitative risk assessments can be developed through several approaches, such as event trees, matrices or indicators. A usual methodology is the one based on a combined evaluation of the likelihood and magnitude/severity of the impact of a hazard on the exposed receptor.

Likelihood analysis can be performed through historical data review or assessment of human error, fault trees and event trees. The analysis of the impacts is usually done through a classification into categories, with increasing levels of severity for the impact.

There are several methods on qualitative and semi-quantitative risk assessment available in published guidelines and standards that can be followed (e.g. WHO Guidelines, 2006; ISO 20426 (2018); FAO and WHO, 2019) (20).

Annex 3 of this Notice illustrates qualitative and semi-quantitative methods for assessing the health risk by using matrices to identify likelihood and severity of impact. It also illustrates a semi-quantitative methodology applicable to water resources. The JRC Technical Report (21) also provides further practical examples.

Quantitative risk assessments can provide a numerical estimation of the risk – for example the impact of specific microbial infection in one year under a specific scenario.

This characterisation of the risks to human and animal health is usually based on dose-response relationships to identify if a hazard or hazardous event might have an effect on health.

A health risk assessment by microbial hazard can be done using a quantitative microbial risk assessment (QMRA), based on evaluating dose-response relationships between the concentration of hazards and the effect it may cause on receptors. The outputs from this method represent the probability values for adverse health effects and are expressed by probability of infection or by the disability-adjusted life years (DALY) indicator.

This approach can answer specific questions that apply to a certain point. Therefore, to cover the whole project and increase the level of security, it can be combined with qualitative or semi-quantitative methods.

Methodologies and criteria for QMRA and DALY can be consulted in the WHO Guidelines (2006) and the WHO Guidelines on QMRA (2016) (22).

A quantitative approach for assessing the environmental risk (Quantitative Chemical Risk Assessment, QCRA) is usually based on:

— the ratio of the predicted environmental concentration, calculated with complex models for fate and transfers of a specific pollutant to environmental compartments; and

— the predicted no-effect concentrations, or the maximum allowable concentration of the pollutant, as set by the applicable legislation (e.g. environmental quality standards applicable to water bodies according to their quality status).

This type of approach requires a significant volume of monitoring data from the water reuse projects and detailed characterisations of the surrounding environment. This means it is applicable only for projects where sufficient data is available and assumptions are supported by scientific evidence.

3.1.6. Conditions relating to the additional requirements

The outcome of the health and environmental risk assessment will help establish if any specific additional requirements (KRM6) for parameters (additional to or stricter than those specified in Section 2 of Annex I) should be added for water quality and monitoring.

This could include additional pathogens or pollutants identified by the health and environmental risk assessment, taking into account the site-specific conditions, as well as the applicable directives and regulations as described before.

For example, the risk assessment could identify that a specific pollutant in reclaimed water (e.g. nitrates) could negatively affect a nearby water body (e.g. by eutrophication), if present in the reclaimed water at higher concentration than the predicted maximum allowable.

Therefore, a limit based on the maximum allowable concentration, resulting from the risk assessment, could be established for the reclaimed water quality, and this parameter could be included among those to be monitored.

The maximum allowable concentrations could also be equal to the required limits, for example, for the specific quality class (e.g. environmental quality standards, EQS) of the exposed water body. A list of additional parameters, along with the identified limits, could be added for water quality and monitoring, if it is clear that they originate from the water reuse system and the reference values for them are supported by the risk assessment and by a sufficient degree of scientific knowledge.

3.1.7. Preventive measures

KRM7 should include the identification of preventive measures and barriers applicable to the water reuse system, to remove or reduce to an acceptable level the identified hazards that might lead to a risk.

Preventive measures are any treatments, actions or procedures, whether already implemented or identified during the risk assessment that can be applied at different parts of the water reuse system. For example: (i) at the UWWTP (i.e. by evaluating the process in place and/or by identifying additional treatments); (ii) at the reclamation facility (e.g. considering adding advanced treatments); (ii) at the irrigated fields (e.g. by considering alternative irrigation methods that minimise risks to exposure, providing buffer zones, etc.), protecting workers and farmers (e.g. identifying specific PPE or hygiene protocols, in addition to possible measures already taken to comply with rules on health and safety at work).

The identification of barriers or modifications to the existing irrigation system could be based on the evaluation of existing methods, type of crops and class of water, and should be decided in consultation with the farmers, and other actors in the water reuse system. Please refer to Annex 4 of this document for examples of preventive measures and barriers.

3.1.8. Quality control and environmental monitoring systems

KRM8 and KRM9 elements include all the monitoring activities planned for the water reuse system: identification of procedures and protocols for the quality control of the system and for the environmental monitoring system (EMS).

Operational and environmental monitoring programmes provide assurances to workers, the public and authorities of adequate system performance. They should include protocols, programmes (e.g. location, parameters, frequency) and procedures for at least the requirements on routine monitoring and any additional parameters and limits identified as additional requirements by the risk assessment (KRM6).

A quality management system, developed according to ISO 9001 standards or equivalent, may also be prepared by the plant operators whenever appropriate.

The EMS protocols should be based on the results of the environmental risk assessment, to ensure continued protection of the environment when using reclaimed water. Protocols should be in line with existing legislation, e.g. water resources monitoring should comply with Directive 90/2009/EC (23) to ensure the results are comparable with those obtained through monitoring under the Water Framework Directive.

3.1.9. Emergency management and coordination

KRM10 and KRM11 include management, emergencies and communication protocols linked to the elements KRM10 (Emergency Management), and KRM11 (Coordination).

These programmes constitute the basis for effective communication between the party(ies) responsible for a risk management plan and the actors involved.

KRM11 should include protocols on how the information will be communicated between actors, formats and procedure for reporting accidents and emergencies, notification procedures, sources of information and consultation processes.

Annex 5 of this Notice can be consulted for examples of (i) protocols for managing incidents and emergencies and (ii) communication protocols.

3.2. Types of crops and reclaimed water classes

For the safe use of reclaimed water, Table 1 - Annex I of the Regulation sets out permitted classes of reclaimed water quality (Class A, B, C, D) that must be used for irrigating a given category of crops, based on the irrigation method chosen.

The minimum water quality requirements for each class in Table 2 - Annex I differ mainly by concentration of E. coli, as well as other aggregate parameters.

With the combination of crop types and the number and type of accredited barriers, such as irrigation methods, risks can be minimised by avoiding any contact between the reclaimed water and the edible parts of irrigated produce (see Annex 4 to this Notice for examples).

To do so, it is important to first establish whether the edible part of the crops will likely be in contact with the reclaimed water. The risk of contact should be assessed for each specific water reuse system, by evaluating the presumed distance of the edible part of the crops to the irrigated soil and the potential pathways of reclaimed water when sprayed, delivered in drops or by flooding.

If the crops undergo additional treatments (e.g. cooking or industrial processes) that reduce potential contamination, these should also be considered.

According to the Regulation, reclaimed water can be used for the agricultural irrigation of:

— Food crops consumed raw: crops cultivated for human consumption, which will not undergo additional processes. Based on the distance (24) of the edible part of the crop from the ground, further classification includes: — Root crops: that grow below ground in the soil and the root portion is edible (e.g. carrots, onions, beetroots) — Above-ground low-growing crops: that grow above ground in partial contact with soil. These crops can be further divided into crops which grow on the soil surface, such a leafy crops (e.g. lettuce) and crops that grow above ground with the edible portion at <25 cm above the soil surface (e.g. tomato, pepper) — Above-ground high-growing crops: that grow above ground and with the edible portions at >50 cm above the soil surface, which therefore do not normally touch the soil (e.g. fruit trees)

— Processed food crops: crops cultivated for human consumption that will undergo additional processes (i.e. cooked or industrially processed) and will not be eaten raw (e.g. rice, wheat)

— Non-food crops (fodder): crops cultivated not for human consumption but for pastures and forage or in other sectors (industrial, energy and seeded crops)

Irrigation methods can be generally classified into:

— Open or gravity-flow irrigation systems: water is applied directly to the soil surface and is not subject to pressure. This includes flood and furrow irrigation.

— Sprinkler irrigation systems: water is sprayed into the air and falls on the soil surface like rainfall.

— Micro irrigation systems: water is applied locally with drip or trickle systems (surface or sub-surface) or by micro-spray irrigation.

Irrigation methods should be assessed as pathways that potentially allow contaminants to reach the crops. For example, with sprayed systems, above-ground high-growing crops (e.g. fruit trees) could be exposed to contamination by falling drops, so a higher quality of water should generally be selected.

Localised systems (e.g. drip irrigation) are associated with a lower contamination risk, since water is directed to the inedible part of crops. Additional appropriate and accredited barriers might be applied to achieve the required water quality class (see Section 3.2.2 and Annex 4).

Any risk to the health of workers or people living near the irrigated area should also be assessed. For example, aerosols from sprinkler irrigation systems could reach receptors living near irrigated areas. Aerosol-related risks depend especially on the irrigation water quality and wind velocity (responsible for disseminating aerosols around the irrigated area).

Note that the irrigation methods and preventive measures or barriers indicated in the following section are examples of a suggested approach on how to interpret Table 1- Annex I. They are not intended to be an exhaustive list.

The irrigation systems and preventive measures or barriers already in place or planned should be assessed in order to identify whether additional requirements (e.g. additional treatments or barriers, changes to the irrigation system) could be needed, to minimise potential crop contamination, depending on the class of reclaimed water.

3.2.1. Examples of irrigation methods and crop types

Figure 4 shows two examples of schematics that could help identify the classes of reclaimed water that provide sufficient protection for consumers and workers against E.coli when irrigating by (a) gravity-flow or pressurised methods or (b) localised systems.

Regardless of the class of water, the schematics take into account additional microbial requirements when reclaimed water is used to irrigate pastures or forages (intestinal nematodes, Note 3 of Figure 4) and where there is risk of aerosols (Legionella spp, Note 1 of Figure 4).

Figure 4

Examples of schematics for selecting the class of reclaimed water (according to the Regulation) for (a) open irrigation methods or (b) localised irrigation methods

The following example from the WHO Safety Plan Guidelines (Worked Example: SSP in Newtown - hypothetical) has been adapted to the requirements of the Regulation, to show how the above schematics could be applied in practice.

Only the elements of this example that are allowed by the Regulation were considered. Reclaimed water was used to grow several types of crops, using different irrigation methods (Table 1).

Table 1

Crop types and irrigation methods used in the example

Crops categories Irrigation methods Destination of crops (*1) — Root crops consumed raw (onions, carrot) — Low-ground leaf crops consumed raw (lettuce, peppers) — High-ground crops consumed raw (fruits) — Flood — Open furrows — Manual applications (e.g. scoops, watering cans) — Spray irrigation — Consumed by farmers and their families — Sold to local community for consumption — Sold to nearby cities for consumption

In this case, according to Tables 1 and 2 of Annex I of the Regulation, considering the potential pathways by which the reclaimed water could reach the crops, the following classes should be selected:

— For root crops and leafy crops consumed raw, when flood, furrow or spray irrigation is applied Class A (E. coli ≤ 10 number/100 mL)

— For food crops that grow low above-ground, consumed raw (e.g. pepper): when flood, furrow or spray irrigation is applied Class A (E. coli ≤ 10 number/100 mL); when drip or sub-surface irrigation systems are used Class B (E. coli ≤100 number/100 mL).

— For food crops grown high above-ground and not in direct contact with reclaimed water (i.e. fruit trees) only when furrow or flood irrigation is applied Class B (E. coli ≤100 number/100 mL).

Based on further risk evaluation, in presence of fruits with edible skin, Class A might be required when spray irrigation is used, to avoid potential contamination of the fruits from the sprayed water. For fruits with inedible skin, Class B could be appropriate, but the final selection of water quality should be based on the risk assessment.

3.2.2. Examples of applying barriers to achieve the required water quality class

Article 2(4) of the Regulation specifies that food business operators can achieve the water quality required to comply with Regulation 852/2004 by using after the point of compliance several water treatment options, either alone or in combination with non-treatment options.

According to the multi-barrier approach, the log reductions to obtain the required water quality class can indeed be achieved by different treatment and non-treatment measures in combination (barriers).

According to Article 3(12) of the Regulation, when reclaimed water is used for irrigation, a barrier is defined as:

— any means, including physical or process-related steps or conditions of use, that reduces or prevents a risk of human infection by preventing contact between reclaimed water and (i) produce that will be ingested, or (ii) and directly exposed persons, or

— other means that, for example, reduce the concentration of microorganisms in the reclaimed water or prevent their survival on the produce that will be ingested.

In other words, and in line with Annex I Section 2 of the Regulation, a barrier should be seen as a means for minimising the risks to levels equivalent to those of the required water quality class for the selected crops.

Different barriers might achieve different log reductions and a combination of them can be applied to the reclaimed water to achieve the required overall log reduction necessary to minimise any risks, based on the selected water quality class.

Table 2 suggests the number of barriers that should be applied to the reclaimed water quality class to obtain the required equivalent level of higher class, based on the type of crop.

Table 3 suggests types of accredited barriers, as well as their related log reduction.

Annex 4 to this Notice contains examples of how to determine the type and number of barriers, based on type of crop and water quality class.

Table 2

Suggested number of barriers needed for irrigation with reclaimed water, according to their quality (adapted from Table 3 of ISO 16075:2020)

NB - changes to the ISO table were made solely to exclude from this table water quality classes and types of crop that are not addressed in the Water Reuse Regulation. See below the table for further explanation on how to interpret this table in relation to the Water Reuse Regulation.

Category(1) Irrigation of vegetables consumed raw(2) Irrigation of vegetables after processing and pastures(3) Irrigation of food crops other than vegetables (orchards, vineyards) and horticulture(4) Irrigation of fodder and seeded crops(5) Irrigation of industrial and energy crops(6) A 0 0 0 0 0 B 1 0 0 0 0 C 3 1 1 0 0 D forbidden forbidden 3 1 (*) 0 The following definitions for each column in the table are in line with Table 1 of Annex 1 to the Water Reuse Regulation and are intended to help the reader find the crop category that broadly corresponds to the ISO categorisation, and thus identify which additional barriers may be needed: (1) Minimum reclaimed water quality class. (2) Food crops consumed raw where the edible part is in direct contact with reclaimed water and root crops consumed raw. (3) Processed food crops and non-food crops, including crops used to feed milk- or meat- producing animals. (4) Food crops consumed raw, where the edible part is produced above ground and it is not in direct contact with reclaimed water. (5) 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 used to feed milk- or meat- producing animals (in both cases, when drip irrigation or another irrigation method is used that avoids direct contact with the edible part of the crop). NB. The seeded crops mentioned here can be seeds for human consumption or for use as animal fodder. (6) Industrial, energy crops, and seeded crops (intended to produce seeds for sowing). (*) Note from ISO 16075:2020: Edible seeds or seeds for sowing which have been irrigated for less than 30 days prior to harvesting. If the period before harvesting is equal to or higher than 30 days, then class D can be directly applicable without restrictions (i.e. without the need for additional barriers).





Table 3

Types of accredited barriers and respective pathogen log reductions (adapted from Table 2 of ISO 16075:2020)

Changes were made solely to exclude from this table water quality classes and types of crop that are not addressed in the Water Reuse Regulation.

Type of barrier Application Pathogen log reduction Number of barriers IRRIGATION OF FOOD CROPS Drip irrigation Drip irrigation of low-growing crops such as 25 cm or more above the ground 2 1 Drip irrigation of high-growing crops such as 50 cm or more above the ground 4 2 Sub-surface drip irrigation where water does not ascend by capillary action to the ground surface 6 3 Spray and sprinkle- irrigation Sprinkler and micro-sprinkler irrigation of low-growing crops such as 25 cm or more from the water jet 2 1 Sprinkler and micro-sprinkler irrigation of fruit trees such as 50 cm or more from the water jet 4 2 Additional disinfection in field Low level disinfection (<1 mg/L of total chlorine, after 30 min. of chlorination) 2 1 High level disinfection (≥1 mg/L of total chlorine, after 30 min. of chlorination) 4 2 Sun resistant cover sheet In drip irrigation, where the sheet separates the irrigation from the vegetables 2 to 4 1 Pathogen die-off Die-off support through irrigation cessation or interruption before harvest 0,5 to 2 per day 1 to 2 Produce washing before selling to the customers Washing salad crops, vegetables, and fruits with drinking water 1 1 Produce disinfection before selling to the customers Washing salad crops, vegetables and fruits with a weak disinfectant solution and rinsing with drinking water 1 1 Produce peeling Peeling of fruits and root crops 2 1 IRRIGATION OF FODDER AND SEEDED CROPS Access control Restricting entry into the irrigated field for 24 h and more after irrigation, for example, animal entering pastures or workers entering fields 0,5 to 2 1 Restricting entry into the irrigated field five days and more after irrigation 2 to 4 2 Sun drying of fodder crops Fodder crops and other crops that are sun-dried and harvested before consumption 2 to 4 2 Note: barriers could already be in place at the irrigation field; crop restrictions and irrigation methods as barriers are already included in the Regulation when selecting reclaimed water quality class and type of crop.

3.3. Validation monitoring

3.3.1. General principles

Validation monitoring is necessary to demonstrate that the design of new water reuse systems or any changes in existing treatment lines will reliably and consistently achieve certain inactivation levels of microbial indicators for Class A of reclaimed water quality (Table 4 – Annex I of the Regulation). Inactivation of microbial indicators is expressed in log10 reduction (25).

Validation monitoring is different from the regular routine monitoring that is performed by the operator (Table 3 - Annex I of the Regulation) to make sure the treatment process is reaching the requirements of the Regulation. It should be seen as an intense, short-term activity to be performed before commissioning or during the start-up phase of new treatment trains or processes, or when they are upgraded.

Changes in the water reuse system that entail process updates might be due, for example, to structural variations in:

1. waste water flow and/or quality due to new discharged permits in the sewage system;

2. population equivalents (P.E.) served by the Urban Waste Water Treatment Plant (UWWTP);

3. climatic conditions (increase in seasonal rainfall or drought events);

4. other conditions not addressed by the risk management plan, which require an update in the technology/processes used.

Because any substantial changes in the capacity of a UWWTP or upgrades in the treatment line of the reuse system will require an existing permit to be reviewed or updated (Article 6(6)), it is recommended to conclude validation monitoring before an authorisation procedure commences.

In any case, during validation activities, reclaimed water might not be delivered for its end-use until monitoring is completed. During this time, reclaimed water could be sent back either to the inlet of the UWWTP or to an identified point of discharge, until the validation’s microbial quality requirements are met.

Once validation monitoring confirms that the new system or technologies meet the requirements for microbial indicators, it will be sufficient to continue with the requirements of routine monitoring.

To support the validation activities, a report illustrating validation monitoring approach, experimental design, and analysis of inlet and outlet samples for the required microbial indicators can be prepared. The report should be prepared by a qualified waste water professional.

Reclamation facilities that were already in operation and continue to meet the reclaimed water quality requirements set out in Table 2 (a) on 25 June 2020 have no obligation to perform validation monitoring.

3.3.2. Validation monitoring protocols

Table 4 - Annex I of the Regulation specifies the log10 reductions to be complied with through validation monitoring on the treatment chain (i.e. between the inlet point for raw waste water into the UWWTP and the point of compliance) for bacteria, viruses and protozoa indicators (E. coli, Campylobacter, total coliphages/F-specific coliphages/somatic coliphages/coliphages, rotavirus, Clostridium perfringens spores/spore-forming sulfate-reducing bacteria and Cryptosporidium).

Because in any given reclamation facility the required log10 reduction could be met by combining different processes, no single, harmonised validation monitoring protocol can be identified. Instead, this should be defined and implemented for each specific case by waste water professionals.

When establishing a validation protocol for a water reuse system, the difference between the concentrations in raw waste water and in the target water quality class will determine the needed number and level of treatments (Figure 5).

For well-established treatment processes, default values of log10 removal are often available from technical guidelines, textbooks and published data; for innovative processes, a testing protocol should be designed to gather log10 reduction data.

Figure 5 shows an example how the target log10 reduction of E. coli can be achieved by the sum of multiple treatments. It is worth noting that, although primary and secondary treatments might reduce the pathogenic bacteria of some logs, disinfection and tertiary treatments are those associated with the highest log reduction and should be carefully characterised.

When a system comprises multiple treatments, log removal values could be determined by technical values or by conducting on-site or off-site pre-testing protocols. On-site validation analysis could then be conducted at the facility(ies), on inlet and outlet samples. Guidelines or standards may be developed at national or other level, to standardise validation monitoring.

Figure 5

Evaluation of an arbitrary multi-barrier water reuse system to reduce E.coli to required log10 reduction for Class A of irrigation (log10 reduction ranges are assumed in Table 3.4 of the Australian Guidelines – see Section 3.3.4)

Once the treatments at the reclamation facility has been identified, there are several strategies for performing validation monitoring, mainly conducting either off-site tests or on-site preliminary tests. Any of these approaches can be used for validation. However, should off-site tests not be enough, on-site testing can complement them. To comply with the validation requirements of the Regulation, it would then be sufficient to test inlet and outlet effluent samples.

The following steps show how to conduct a pre-testing protocol:

— Available performance data on treatments against microbial indicators could first be gathered by consulting technical data sheets from suppliers, published scientific and technical literature, guidelines from legislative authorities or professional bodies, and historical data. This would determine if any process is well-established or pre-testing is necessary.

— If enough technical data is available to prove that the treatments will meet the validation requirements, a pre-testing protocol might not be necessary.

However, it will still be necessary to conduct the analysis required by Table 4 of Annex I to the Regulation, for validation monitoring during the start-up phase in the inlet and outlet effluent, to prove that microbial log10 reductions are achieved.

Preliminary tests could be performed for the specific process/technology on the most challenging organisms for each group of microbial indicators (bacteria, virus, and protozoa), and then validated for all the groups.

Laboratory tests (off-site) or pilot tests (off-site or on-site) might be implemented for innovative technologies, to collect specific design parameters or when there is a lack of data on the performance of the technology.

Experimental design can be developed based on available information and the expertise of waste water professionals. Laboratory tests could be performed on real waste water or, if this is not possible, a solution can be prepared with spiked target organisms. Samples could then be further analysed on-site to confirm laboratory observations.

— For on-site tests, the reclamation facility operators could perform validation monitoring, after having established the protocol. Where needed, they could also be supported by independent and qualified professionals, to oversee the activities. Analysis of validation monitoring should be performed by an independent and certified laboratory.

— For microbial monitoring, it is important to perform analysis on a number of samples that is statistically valid – so at least three samples at each sample point to allow the calculation of averages and standard deviations.

It is suggested that standard deviation should be less than 1 log10 among the samples. At least 90 % of samples should meet the performance targets. The frequency and duration of validation monitoring should be established on the basis of the protocol developed for the specific case.

— If there is no biological indicator in the reclaimed water, the validation requirements are not needed. In particular, if the microbial indicator is not present in the raw waste water, or it is present at a low concentration, it is considered that validation monitoring has approved that indicator.

3.3.3. Validation monitoring examples

The following case was selected from the Australian Guidelines as an example of how a validation monitoring protocol might be performed under the requirements of the Regulation.

In this case, spray irrigation of salad crops with reclaimed water from a UWWTP was planned. Validation monitoring was required during the commissioning of the new plant and before the approval of the water reuse system (in the terms of the Regulation, before granting a permit).

In this example, the system was not designed on the basis of available technical standards, thus default values for log reduction were not available. Therefore, a testing plan at lab and pilot scale was necessary to obtain performance data on the inactivation of selected microbes.

The treatment chain for the water reuse system included: secondary treatment, lagoon, coagulation, dissolved air flotation and filtration, and chlorination. Table 2 reports the initial and final concentrations from the performed analysis. For reference, the last column reports the minimum requirements under the Regulation.

Table 2

Validation monitoring results according to an example available in the Australian Guidelines

Indicator microorganisms (*2) Initial concentration in raw waste water Concentration in treated waste water Total log reduction Performance target from Regulation (Table 4 of Annex I) Cryptosporidium 2 000 /litre <1 /50 litres 5 log ≥5 log Giardia 20 000 /litre <1 /50 litres NA NA Adenoviruses, reoviruses, enteroviruses, hepatitis A 8 000 /litre <1 /50 litres 5,5 log NA E. coli NA <1 CFU/100 mL >6 log ≥5 log

3.3.4. Additional resources

Because a validation monitoring procedure should be designed to cover specific treatments, some external resources are reported here for consideration by waste water practitioners, to help them implement a specific protocol.

Validation aspect Reference Typical log10 reduction ranges for microbial indicators in conventional waste water treatment processes (26) — Table 3.4, Chapter 3, Australian Guidelines for Water recycling: Managing Health and Environmental Risks, 2006. — Table 1 - Global water pathogen project part four. Management of risk from excreta and waste water pathogen reduction and survival in complete treatment works, 2019 — Metcalf & Eddy Inc., et al. Waste Water Engineering: Treatment and Resource Recovery. 5th ed., McGraw-Hill Professional, 2013. Validation protocols for disinfection systems — ISO 20468-4 Guidelines for performance evaluation of treatment technologies for water reuse systems - Part-4: UV Disinfection — USEPA. 2006. Ultraviolet Disinfection Guidance Manual for the Final Long Term 2 Enhanced Surface Water Treatment Rule. EPA 815-R-06-007. U.S. Environmental Protection Agency, Office of Water, Washington, DC. U.S. Environmental Protection Agency, Office of Water, Washington, DC.USEPA, 2005. Membrane Filtration Guidance Manual. EPA 815-R-06-009. U.S. Environmental Protection Agency, Office of Water, Washington, DC. — Metcalf & Eddy Inc., et al. Waste Water Engineering: Treatment and Resource Recovery. 5th ed., McGraw-Hill Professional, 2013.W

(1) Both the Circular Economy Action Plan (COM/2020/98 final) and the EU’s new climate adaptation strategy (COM/2021/82 final) refer to water reuse, as the EU’s ability to respond to the increasing pressures on water resources could be improved by wider reuse of treated waste water. In addition to irrigation, water reuse can also be usefully applied in the industrial sector, contributing to the goals set in the Commission’s proposal for a revised Industrial Emissions Directive (COM(2022) 156 final/2).

(2) OJ L 177, 5.6.2020, p. 32.

(3) Water reuse could contribute to the goal of reducing the environmental and climate footprint of the EU food system, set out in the Farm to Fork Strategy (COM/2020/381 final).

(4) OJ L 135, 30.5.1991, p. 40, the Urban Waste Water Treatment Directive requires that treated waste water be reused whenever appropriate. This Directive is currently under review, but the planned future legislative set up is expected to reinforce the link to the practice of water reuse. Thus, any reference to this Directive in this Notice will in future refer to the planned revised legislation on the treatment of urban waste water.

(5) Formerly called Ad Hoc Task Group on Water Reuse, set up as a permanent Working Group in 2022.

(6) For more information on this group: https://circabc.europa.eu/ui/group/9ab5926d-bed4-4322-9aa7-9964bbe8312d/library/3644e20b-f5c5-46de-9d2f-3d9efb965fac?p=1&n=10&sort=modified_DESC

(7) Article 5(4) of Regulation (EU) 2021/1119 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999, OJ L 243, 9.7.2021, p. 1, Article 19(1) of Regulation (EU) 2018/1999 on the Governance of the Energy Union and Climate Action (OJ L 328, 21.12.2018, p. 1).

(8) Regulation (EC) No 178/2002 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).

(9) Regulation (EC) No 852/2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

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

(11) Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products (OJ L 95, 7.4.2017, p. 1).

(12) Commission notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene (OJ C 163, 23.5.2017, p. 1).

(13) https://ec.europa.eu/environment/water/pdf/Guidelines_on_water_reuse.pdf

(14) R. Maffettone and B. M. Gawlik (2022), Technical Guidance: Water Reuse Risk Management for Agricultural Irrigation Schemes in Europe, European Commission, Luxembourg, JRC 129596.

(15) Acute effects: health effects that usually occur rapidly, as a result of short-term exposure. Chronic effect: adverse health effect resulting from long-term exposure to a substance.

(16) WHO Guidelines for the Safe Use of Wastewater, Excreta and Greywater (WHO, 2006).

(17) WISE Freshwater resource catalogue - https://water.europa.eu/freshwater/data-maps-and-tools/metadata#surface-water-bodies-priority-substances-2nd-rbmp-overview-chart

(18) Environmental Quality Standards – ECHA - https://echa.europa.eu/environmental-quality-standards

(19) The European Pollutant Release and Transfer Register – https://ec.europa.eu/environment/industry/stationary/e-prtr/legislation.htm

(20) FAO and WHO, 2019. Safety and Quality of Water Used in Food Production and Processing – Meeting report. Microbiological Risk Assessment Series No 33 Rome – https://www.fao.org/3/ca6062en/CA6062EN.pdf

(21) R. Maffettone and B. M. Gawlik (2022), Technical Guidance: Water Reuse Risk Management for Agricultural Irrigation Schemes in Europe, European Commission, Luxembourg, JRC 129596

(22) WHO, 2016. Quantitative Microbial Risk Assessment: Application for Water Safety Management. World Health Organisation, Geneva, Switzerland – https://apps.who.int/iris/handle/10665/246195

(23) Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC, technical specifications for chemical analysis and monitoring of water status (OJ L 201, 1.8.2009, p. 36).

(24) Please see Annex 4 for examples on distances between edible parts of the crops and irrigated ground.

(*1) Without prejudice to the current legislation and guidance documents already in place for food safety and hygiene. Note that, according to the boundaries of Figure 2, the risk assessment will end at the point at which the crop is produced.

(25) 1-log removal = 90 % reduction in density of the target organism, 2-log removal = 99 % reduction, 3-log removal = 99,9 % reduction, etc.

(*2) detected using cell culture except in the case of hepatitis A, which was detected using the polymerase chain reaction

(26) Reduction rates depend on specific operating conditions, such as retention times, contact times and concentrations of chemicals used, pore size, filter depths, pre-treatment, and other factors. Ranges given should not be used as a basis for design or regulation – they are meant to show relative comparisons during the design of the validation monitoring protocol.