Regulation (EU) 2020/741 of the European Parliament and of the Council of 25 May 2020 on minimum requirements for water reuse (Text with EEA relevance)

• CELEX: Regulation (EU) 2020/741
• Articles: 18

Article 1 Subject matter and purpose

1.   This Regulation lays down minimum requirements for water quality and monitoring and provisions on risk management, for the safe use of reclaimed water in the context of integrated water management.

2.   The purpose of this Regulation is to guarantee that reclaimed water is safe for agricultural irrigation, thereby ensuring a high level of protection of the environment and of human and animal health, promoting the circular economy, supporting adaptation to climate change, and contributing to the objectives of Directive 2000/60/EC by addressing water scarcity and the resulting pressure on water resources, in a coordinated way throughout the Union, thus also contributing to the efficient functioning of the internal market.

Article 2 Scope

1.   This Regulation applies whenever treated urban waste water is reused, in accordance with Article 12(1) of Directive 91/271/EEC, for agricultural irrigation as specified in Section 1 of Annex I to this Regulation.

2.   A Member State may decide that it is not appropriate to reuse water for agricultural irrigation in one or more of its river basin districts or parts thereof, taking into account the following criteria:

(a)

the geographic and climatic conditions of the district or parts thereof;

(b)

the pressures on and the status of other water resources, including the quantitative status of groundwater bodies as referred to in Directive 2000/60/EC;

(c)

the pressures on and the status of the surface water bodies in which treated urban waste water is discharged;

(d)

the environmental and resource costs of reclaimed water and of other water resources.

Any decision taken pursuant to the first subparagraph shall be duly justified on the basis of the criteria referred to in that subparagraph and submitted to the Commission. It shall be reviewed as necessary, in particular taking into account climate change projections and national climate change adaptation strategies, and at least every six years taking into account river basin management plans established pursuant to Directive 2000/60/EC.

3.   By way of derogation from paragraph 1, research or pilot projects in relation to reclamation facilities may be exempted from this Regulation where the competent authority establishes that the following criteria are met:

(a)

the research or pilot project will not be carried out within a water body used for the abstraction of water intended for human consumption or a relevant safeguard zone designated pursuant to Directive 2000/60/EC;

(b)

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

Any exemption pursuant to this paragraph shall be limited to a maximum period of five years.

Crops resulting from a research or pilot project exempted pursuant to this paragraph shall not be placed on the market.

4.   This Regulation applies without prejudice to Regulation (EC) No 852/2004 and does not preclude food business operators from obtaining the water quality required to comply with that Regulation by using, at a subsequent stage, several water treatment options alone or in combination with non-treatment options, or from using alternative water sources for agricultural irrigation.

Article 3 Definitions

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

(1)

‘competent authority’ means an authority or a body designated by a Member State to carry out its obligations under this Regulation regarding the granting of permits for the production or supply of reclaimed water, regarding exemptions for research or pilot projects and regarding compliance checks;

(2)

‘end-user’ means a natural or legal person, whether a public or private entity, that uses reclaimed water for agricultural irrigation;

(3)

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

(4)

‘reclaimed water’ means urban waste water that has been treated in compliance with the requirements set out in Directive 91/271/EEC and which results from further treatment in a reclamation facility in accordance with Section 2 of Annex I to this Regulation;

(5)

‘reclamation facility’ means an urban waste water treatment plant or other facility that further treats urban waste water that complies with the requirements set out in Directive 91/271/EEC in order to produce water that is fit for a use specified in Section 1 of Annex I to this Regulation;

(6)

‘reclamation facility operator’ means a natural or legal person, representing a private entity or a public authority, that operates or controls a reclamation facility;

(7)

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

(8)

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

(9)

‘risk management’ means systematic management that consistently ensures that water reuse is safe in a specific context;

(10)

‘preventive measure’ means an appropriate action or activity that can prevent or eliminate a health or environmental risk, or that can reduce such a risk to an acceptable level;

(11)

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

(12)

‘barrier’ is any means, including physical or process-related steps or conditions of use, that reduces or prevents a risk of human infection by preventing contact of reclaimed water with produce to be ingested and directly exposed persons, or other means that, for example, reduces the concentration of microorganisms in the reclaimed water or prevents their survival on the produce to be ingested;

(13)

‘permit’ means a written authorisation issued by a competent authority to produce or supply reclaimed water for agricultural irrigation in accordance with this Regulation;

(14)

‘responsible party’ means a party carrying out a role or activity in the water reuse system, including the reclamation facility operator, the urban waste water treatment plant operator where different from the reclamation facility operator, the relevant authority other than the designated competent authority, the reclaimed water distribution operator or the reclaimed water storage operator;

(15)

‘water reuse system’ means the infrastructure and other technical elements necessary for producing, supplying and using reclaimed water; it comprises all the elements from the entry point of the urban waste water treatment plant to the point where reclaimed water is used for agricultural irrigation, including distribution and storage infrastructure, where relevant.

Article 4 Obligations of the reclamation facility operator and obligations regarding reclaimed water quality

1.   The reclamation facility operator shall ensure that, at the point of compliance, reclaimed water intended for agricultural irrigation as specified in Section 1 of Annex I complies with the following:

(a)

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

(b)

any additional conditions set by the competent authority in the relevant permit pursuant to points (c) and (d) of Article 6(3), as regards water quality.

Beyond the point of compliance, the quality of the water shall no longer be the responsibility of the reclamation facility operator.

2.   In order to ensure compliance in accordance with paragraph 1, the reclamation facility operator shall monitor water quality in accordance with the following:

(a)

Section 2 of Annex I;

(b)

any additional conditions set by the competent authority in the relevant permit pursuant to points (c) and (d) of Article 6(3), as regards monitoring.

Article 5 Risk management

1.   For the purpose of producing, supplying and using reclaimed water, the competent authority shall ensure that a water reuse risk management plan is established.

One water reuse risk management plan may cover one or more water reuse systems.

2.   The water reuse risk management plan shall be prepared by the reclamation facility operator, other responsible parties and end-users, as appropriate. The responsible parties preparing the water reuse risk management plan shall consult all other relevant responsible parties and end-users, as appropriate.

3.   The water reuse risk management plan shall be based on all the key elements of risk management set out in Annex II. It shall identify the risk management responsibilities of the reclamation facility operator and other responsible parties.

4.   The water reuse risk management plan shall in particular:

(a)

set out any necessary requirements for the reclamation facility operator, in addition to those specified in Annex I, in accordance with point (B) of Annex II to further mitigate any risks before the point of compliance;

(b)

identify hazards, risks and appropriate preventive and/or possible corrective measures in accordance with point (C) of Annex II;

(c)

identify additional barriers in the water reuse system and set out any additional requirements, which are necessary after the point of compliance to ensure that the water reuse system is safe, including conditions related to distribution, storage and use where relevant, and identify the parties responsible for meeting those requirements.

5.   The Commission is empowered to adopt delegated acts in accordance with Article 13 amending this Regulation in order to adapt to technical and scientific progress the key elements of risk management set out in Annex II.

The Commission is also empowered to adopt delegated acts in accordance with Article 13 supplementing this Regulation in order to lay down technical specifications of the key elements of risk management set out in Annex II.

Article 6 Reclaimed water permit obligations

1.   The production and supply of reclaimed water intended for agricultural irrigation as specified in Section 1 of Annex I shall be subject to a permit.

2.   The responsible parties in the water reuse system, including the end-user where relevant in accordance with national law, shall submit an application for a permit or for a modification of an existing permit to the competent authority of the Member State in which the reclamation facility operates or is planned to operate.

3.   The permit shall set out the obligations of the reclamation facility operator and, where relevant, of any other responsible parties. The permit shall be based on the water reuse risk management plan and shall specify, inter alia, the following:

(a)

the reclaimed water quality class or classes and the agricultural use for which, in accordance with Annex I, the reclaimed water is permitted, the place of use, the reclamation facilities and the estimated yearly volume of the reclaimed water to be produced;

(b)

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

(c)

any conditions in relation to additional requirements for the reclamation facility operator, set out in the water reuse risk management plan;

(d)

any other conditions necessary to eliminate any unacceptable risks to the environment and to human and animal health so that any risks are of an acceptable level;

(e)

the validity period of the permit;

(f)

the point of compliance.

4.   For the purpose of assessing an application, the competent authority shall consult and exchange relevant information with other relevant authorities, in particular the water and health authorities if different from the competent authority, and any other party which the competent authority considers relevant.

5.   The competent authority shall decide without delay whether to grant a permit. Where, due to the complexity of an application, the competent authority needs more than 12 months from the receipt of a complete application to decide whether to grant a permit, it shall communicate the expected date of its decision to the applicant.

6.   Permits shall be regularly reconsidered, and shall be updated where necessary, at least in the following cases:

(a)

there has been a substantial change in capacity;

(b)

equipment has been upgraded;

(c)

new equipment or processes have been added; or

(d)

there have been changes in climatic or other conditions which significantly affect the ecological status of surface water bodies.

7.   Member States may require that storage, distribution and use of reclaimed water be subject to a specific permit in order to apply the additional requirements and barriers identified in the water reuse risk management plan as referred to in Article 5(4).

Article 7 Compliance check

1.   The competent authority shall verify whether there is compliance with the conditions set out in the permit. Compliance checks shall be carried out through the following means:

(a)

on-the-spot checks;

(b)

monitoring data obtained in particular pursuant to this Regulation;

(c)

any other adequate means.

2.   In the event of non-compliance with the conditions set out in the permit, the competent authority shall require the reclamation facility operator and, where relevant, the other responsible parties to take any necessary measures to restore compliance without delay and immediately inform the end-users affected.

3.   Where non-compliance with the conditions set out in the permit represents a significant risk to the environment or to human or animal health, the reclamation facility operator or any other responsible parties shall immediately suspend supply of the reclaimed water until the competent authority determines that compliance has been restored, following procedures defined in the water reuse risk management plan, in accordance with point (a) of Section 2 of Annex I.

4.   If an incident affecting compliance with the conditions set out in the permit occurs, the reclamation facility operator or any other responsible parties shall immediately inform the competent authority and other parties which could potentially be affected, and communicate to the competent authority the information necessary for assessing the impact of such an incident.

5.   The competent authority shall regularly verify compliance by the responsible parties with the measures and tasks set out in the water reuse risk management plan.

Article 8 Cooperation between Member States

1.   Where water reuse is of cross-border relevance, Member States shall designate a contact point for the purposes of cooperation with other Member States’ contact points and competent authorities, as appropriate, or shall use existing structures stemming from international agreements.

The role of contact points or existing structures shall be to:

(a)

receive and transmit requests for assistance;

(b)

provide assistance upon request; and

(c)

coordinate communication between competent authorities.

Before granting a permit, competent authorities shall exchange information on the conditions set out in Article 6(3) with the contact point in the Member State in which reclaimed water is intended to be used.

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

Article 9 Information and awareness-raising

Savings of water resources as a result of water reuse shall be the subject of general awareness-raising campaigns in Member States where reclaimed water is used for agricultural irrigation. Such campaigns may include the promotion of the benefits of safe water reuse.

Those Member States may also set up information campaigns for end-users to ensure the optimal and safe use of reclaimed water, thereby ensuring a high level of protection of the environment and of human and animal health.

Member States may adapt such information and awareness-raising campaigns to the scale of water reuse.

Article 10 Information to the public

1.   Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States in which reclaimed water is used for agricultural irrigation as specified in Section 1 of Annex I to this Regulation shall ensure that adequate and up-to-date information on water reuse is available to the public, online or by other means. That information shall include the following:

(a)

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

(b)

the percentage of the reclaimed water in the Member State supplied in accordance with this Regulation compared to the total amount of treated urban waste water, where such data are available;

(c)

the permits granted or modified in accordance with this Regulation, including the conditions set by competent authorities in accordance with Article 6(3) of this Regulation;

(d)

the results of any compliance checks carried out in accordance with Article 7(1) of this Regulation;

(e)

the contact points designated in accordance with Article 8(1) of this Regulation.

2.   The information referred to in paragraph 1 shall be updated every two years.

3.   Member States shall ensure that any decision taken in accordance with Article 2(2) is made available to the public, online or by other means.

Article 11 Information relating to monitoring of implementation

1.   Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States in which reclaimed water is used for agricultural irrigation as specified in Section 1 of Annex I to this Regulation, assisted by the European Environment Agency, shall:

(a)

set up and publish by 26 June 2026, and update every six years thereafter, a data set containing information on the outcome of the compliance check performed in accordance with Article 7(1) of this Regulation and other information to be made available to the public, online or by other means, in accordance with Article 10 of this Regulation;

(b)

set up, publish and update annually thereafter, a data set containing information on cases of non-compliance with the conditions set out in the permit, which has been collected in accordance with Article 7(1) of this Regulation, and information on the measures taken in accordance with Article 7(2) and (3) of this Regulation.

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

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

4.   The Commission may, by means of implementing acts, lay down detailed rules regarding the format and presentation of the information to be provided in accordance with paragraph 1 as well as detailed rules regarding the format and presentation of the Union-wide overview referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14.

5.   By 26 June 2022, the Commission shall, in consultation with Member States, establish guidelines to support the application of this Regulation.

Article 12 Evaluation and review

1.   The Commission shall, by 26 June 2028, carry out an evaluation of this Regulation. The evaluation shall be based on at least the following:

(a)

the experience gathered from the implementation of this Regulation;

(b)

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

(c)

relevant scientific, analytical and epidemiological data;

(d)

technical and scientific knowledge;

(e)

WHO recommendations, where available, or other international guidance or ISO standards.

2.   In carrying out the evaluation, the Commission shall pay particular attention to the following aspects:

(a)

the minimum requirements set out in Annex I;

(b)

the key elements of risk management set out in Annex II;

(c)

the additional requirements set by competent authorities pursuant to points (c) and (d) of Article 6(3);

(d)

the impact of water reuse on the environment and on human and animal health, including the impact of substances of emerging concern.

3.   As part of the evaluation, the Commission shall assess the feasibility of:

(a)

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

(b)

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

4.   Based on the results of the evaluation or whenever new technical and scientific knowledge so requires, the Commission may examine the need to review the minimum requirements set out in Section 2 of Annex I.

5.   Where appropriate, the Commission shall submit a legislative proposal to amend this Regulation.

Article 13 Exercise of the delegation

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

2.   The power to adopt delegated acts referred to in Article 5(5) shall be conferred on the Commission for a period of five years from 25 June 2020. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

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

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

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

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

Article 14 Committee procedure

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

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

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

Article 15 Penalties

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 26 June 2024, notify the Commission of those rules and of those measures and shall notify it of any subsequent amendment affecting them.

Article 16 Entry into force and application

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

It shall apply from 26 June 2023.

Schedules & Appendices

ANNEX I USES AND MINIMUM REQUIREMENTS

ANNEX I

USES AND MINIMUM REQUIREMENTS

Section 1

Uses of reclaimed water

Agricultural irrigation

Agricultural irrigation means irrigation of the following types of crops:

—

food crops consumed raw, meaning crops which are intended for human consumption in a raw or unprocessed state;

—

processed food crops, meaning crops which are intended for human consumption after a treatment process (i.e. cooked or industrially processed);

—

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

Without prejudice to other relevant Union law in the fields of the environment and of health, Member States may use reclaimed water for further uses such as:

—

industrial water reuse; and

—

amenity-related and environmental purposes.

Section 2

Minimum requirements

Minimum requirements applicable to reclaimed water intended for agricultural irrigation

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

Crops belonging to a given category shall be irrigated with reclaimed water of the corresponding minimum reclaimed water quality class as set out in Table 1, unless appropriate additional barriers as referred to in point (c) of Article 5(4) are used, which result in achieving the quality requirements set out in Table 2 of point (a). Such additional barriers may be based on the indicative list of preventive measures referred to in point 7 of Annex II or in any other equivalent national or international standards, e.g. the standard ISO 16075-2.

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

Minimum reclaimed water quality class

Crop category  ( *1 )

Irrigation method

A

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

All irrigation methods

B

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

All irrigation methods

C

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

Drip irrigation  ( *2 ) or other irrigation method that avoids direct contact with the edible part of the crop

D

Industrial, energy and seeded crops

All irrigation methods  ( *3 )

(a)   Minimum requirements for water quality

Table 2 – Reclaimed water quality requirements for agricultural irrigation

Reclaimed water quality class

Indicative technology target

Quality requirements

E. coli

(number/100 ml)

BOD 5

(mg/l)

TSS

(mg/l)

Turbidity

(NTU)

Other

A

Secondary treatment, filtration, and disinfection

≤ 10

≤ 10

≤ 10

≤ 5

Legionella spp.: < 1 000 cfu/l where there is a risk of aerosolisation

Intestinal nematodes (helminth eggs): ≤ 1 egg/l for irrigation of pastures or forage

B

Secondary treatment, and disinfection

≤ 100

In accordance with Directive 91/271/EEC

(Annex I, Table 1)

In accordance with Directive 91/271/EEC

(Annex I, Table 1)

-

C

Secondary treatment, and disinfection

≤ 1 000

-

D

Secondary treatment, and disinfection

≤ 10 000

-

Reclaimed water shall be considered to be in compliance with the requirements set out in Table 2 where the measurements for that reclaimed water meet all of the following criteria:

—

the indicated values for E. coli , Legionella spp. and intestinal nematodes are met in 90 % or more of the samples; none of the values of the samples exceed the maximum deviation limit of 1 log unit from the indicated value for E. coli and Legionella spp. and 100 % of the indicated value for intestinal nematodes;

—

the indicated values for BOD 5 , TSS, and turbidity in Class A are met in 90 % or more of the samples; none of the values of the samples exceed the maximum deviation limit of 100 % of the indicated value.

(b)   Minimum requirements for monitoring

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

The samples to be used to verify compliance with the microbiological parameters at the point of compliance shall be taken in accordance with standard EN ISO 19458 or with any other national or international standards that ensure equivalent quality.

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

Minimum monitoring frequencies

Reclaimed water quality class

E. coli

BOD 5

TSS

Turbidity

Legionella spp.

(when applicable)

Intestinal nematodes

(when applicable)

A

Once a week

Once a week

Once a week

Continuous

Twice a month

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

B

Once a week

In accordance with Directive 91/271/EEC

(Annex I, Section D)

In accordance with Directive 91/271/EEC

(Annex I, Section D)

-

C

Twice a month

-

D

Twice a month

-

Validation monitoring shall be performed before a new reclamation facility is put into operation.

Reclamation facilities that are already in operation and that meet the reclaimed water quality requirements set out in Table 2 of point (a) on 25 June 2020 shall be exempted from that validation monitoring obligation.

However, validation monitoring shall be performed in all cases where equipment is upgraded, and when new equipment or processes are added.

Validation monitoring shall be performed for the reclaimed water quality class with the most stringent requirements, Class A, to assess whether the performance targets (log 10 reduction) are complied with. Validation monitoring shall entail the monitoring of the indicator microorganisms associated with each group of pathogens, namely bacteria, viruses and protozoa. The indicator microorganisms selected are E. coli for pathogenic bacteria, F-specific coliphages, somatic coliphages or coliphages for pathogenic viruses, and Clostridium perfringens spores or spore-forming sulfate-reducing bacteria for protozoa. Performance targets (log 10 reduction) for the validation monitoring for the selected indicator microorganisms are set out in Table 4 and shall be met at the point of compliance, considering the concentrations of the raw waste water entering the urban waste water treatment plant. At least 90 % of validation samples shall reach or exceed the performance targets.

If a biological indicator is not present in sufficient quantity in raw waste water to achieve the log 10 reduction, the absence of such biological indicator in reclaimed water shall mean that the validation requirements are complied with. The compliance with the performance target may be established by analytical control, by addition of the performance granted to individual treatment steps based on scientific evidence for standard well-established processes, such as published data of testing reports or case studies, or tested in a laboratory under controlled conditions for innovative treatment.

Table 4 – Validation monitoring of reclaimed water for agricultural irrigation

Reclaimed water quality class

Indicator microorganisms  ( *4 )

Performance targets for the treatment chain

(log 10 reduction)

A

E. coli

≥ 5,0

Total coliphages/F-specific coliphages/somatic coliphages/coliphages  ( *5 )

≥ 6,0

Clostridium perfringens spores/spore-forming sulfate-reducing bacteria  ( *6 )

≥ 4,0 (in case of Clostridium perfringens spores)

≥ 5,0 (in case of spore-forming sulfate-reducing bacteria)

Methods of analysis for monitoring shall be validated and documented in accordance with EN ISO/IEC-17025 or other national or international standards that ensure an equivalent quality.

( *1 )   If the same type of irrigated crop falls under multiple categories of Table 1, the requirements of the most stringent category shall apply.

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

( *3 )   In the case of irrigation methods which imitate rain, special attention should be paid to the protection of the health of workers or bystanders. For this purpose, appropriate preventive measures shall be applied.

( *4 )   The reference pathogens Campylobacter , Rotavirus and Cryptosporidium may also be used for validation monitoring purposes instead of the proposed indicator microorganisms. The following log 10 reduction performance targets shall then apply: Campylobacter (≥ 5,0), Rotavirus (≥ 6,0) and Cryptosporidium (≥ 5,0).

( *5 )   Total coliphages is selected as the most appropriate viral indicator. However, if analysis of total coliphages is not feasible, at least one of them (F-specific or somatic coliphages) shall be analysed.

( *6 )

Clostridium perfringens spores is selected as the most appropriate protozoa indicator. However, spore-forming sulfate-reducing bacteria are an alternative if the concentration of Clostridium perfringens spores does not make it possible to validate the requested log 10 removal.

ANNEX II

ANNEX II

(A)

Key elements of risk management

Risk management shall comprise identifying and managing risks in a proactive way to ensure that reclaimed water is safely used and managed and that there is no risk to the environment or to human or animal health. For those purposes, a water reuse risk management plan shall be established on the basis of the following elements:

1.

Description of the entire water reuse system, from the entry of waste water into the urban waste water treatment plant to the point of use, including the sources of waste water, the treatment steps and the technologies used at the reclamation facility, the supply, distribution and storage infrastructure, the intended use, the place and period of use (e.g. temporary or ad-hoc use), the irrigation method, the crop type, other water sources if a mix is intended to be used and the volume of reclaimed water to be supplied.

2.

Identification of all parties involved in the water reuse system and a clear description of their roles and responsibilities.

3.

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

4.

Identification of the environments and populations at risk, and the exposure routes to the identified potential hazards, taking into account specific environmental factors, such as local hydrogeology, topology, soil type and ecology, and factors related to the type of crops and farming and irrigation practices. Consideration of possible irreversible or long-term negative environmental and health effects of the water reclamation operation, supported by scientific evidence.

5.

Assessment of risks to the environment and to human and animal health, taking into account the nature of the identified potential hazards, the duration of the intended uses, the identified environments and populations at risk of exposure to those hazards and the severity of possible effects of the hazards considering the precautionary principle, as well as all relevant Union and national legislation, guidance documents and minimum requirements in relation to food and feed and worker safety. The risk assessment could be based on a review of available scientific studies and data.

The risk assessment shall consist of the following elements:

(a)

an assessment of risks to the environment, including all of the following:

(i)

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

(ii)

assessment of the potential range of exposure;

(iii)

characterisation of the risks;

(b)

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

(i)

confirmation of the nature of the hazards, including, where relevant, the dose-response relationship;

(ii)

assessment of the potential range of dose or exposure;

(iii)

characterisation of the risks.

The risk assessment may be carried out using qualitative or semi-quantitative risk assessment. Quantitative risk assessment shall be used when there are sufficient supporting data or in projects having a potential high risk for the environment or public health.

The following requirements and obligations shall, as a minimum, be taken into account in the risk assessment:

(a)

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

(b)

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

(c)

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

(d)

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

(e)

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

(f)

the requirement to meet the environmental quality standards for pollutants of national concern, namely river basin specific pollutants, laid down in Directive 2000/60/EC;

(g)

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

(h)

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

(i)

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

(j)

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

(k)

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

(l)

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

(m)

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

(n)

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

(B)

Conditions relating to the additional requirements

6.

Consideration of requirements for water quality and monitoring that are additional to or stricter than those specified in Section 2 of Annex I, or both, when necessary and appropriate to ensure adequate protection of the environment and of human and animal health, in particular when there is clear scientific evidence that the risk originates from reclaimed water and not from other sources.

Depending on the outcome of the risk assessment referred to in point 5, such additional requirements may in particular concern:

(a)

heavy metals;

(b)

pesticides;

(c)

disinfection by-products;

(d)

pharmaceuticals;

(e)

other substances of emerging concern, including micro pollutants and micro plastics;

(f)

anti-microbial resistance.

(C)

Preventive measures

7.

Identification of preventive measures that are already in place or that should be taken to limit risks so that all identified risks can be adequately managed. Special attention shall be paid to water bodies used for the abstraction of water intended for human consumption and relevant safeguard zones.

Such preventive measures may include:

(a)

access control;

(b)

additional disinfection or pollutant removal measures;

(c)

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

(d)

specific requirements for sprinkler irrigation (e.g. maximum wind speed, distances between sprinkler and sensitive areas);

(e)

specific requirements for agricultural fields (e.g. slope inclination, field water saturation and karstic areas);

(f)

pathogen die-off support before harvest;

(g)

establishment of minimum safety distances (e.g. from surface water, including sources for livestock, or activities such as aquaculture, fish farming, shellfish aquaculture, swimming and other aquatic activities);

(h)

signage at irrigation sites, indicating that reclaimed water is being used and is not suitable for drinking.

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

Table 1 – Specific preventive measures

Reclaimed water quality class

Specific preventive measures

A

—

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

B

—

Prohibition of harvesting of wet irrigated or dropped produce.

—

Exclude lactating dairy cattle from pasture until pasture is dry.

—

Fodder has to be dried or ensiled before packaging.

—

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

C

—

Prohibition of harvesting of wet irrigated or dropped produce.

—

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

—

Fodder has to be dried or ensiled before packaging.

—

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

D

—

Prohibition of harvesting of wet irrigated or dropped produce.

8.

Adequate quality control systems and procedures, including monitoring the reclaimed water for relevant parameters, and adequate maintenance programmes for equipment.

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

9.

Environmental monitoring systems to ensure that feedback from the monitoring is provided and that all processes and procedures are appropriately validated and documented.

10.

Appropriate systems to manage incidents and emergencies, including procedures to inform all relevant parties of such events in an appropriate manner, and regular updates of emergency response plan.

Member States could use existing international guidance or standards, such as ISO 20426:2018 Guidelines for health risk assessment and management for non-potable water reuse, ISO 16075:2015 Guidelines for treated waste water use for irrigation projects or other equivalent standards accepted at international level, or WHO guidelines, as instruments for the systematic identification of hazards, the evaluation and the management of risks, based on a priority approach applied to the whole chain (from the treatment of urban waste water for reuse, to the distribution and the utilisation for agricultural irrigation, to the control of the effects) and on site specific risk assessment.

11.

Ensure that coordination mechanisms are established amongst different actors to guarantee the safe production and use of reclaimed water.