(1)

The Union is committed to building an Energy Union with a forward‐looking climate policy. Fuel efficiency is a crucial element of the Union’s 2030 climate and energy policy framework and is key to moderating energy demand.

(2)

The Commission has reviewed Regulation (EC) No 1222/2009 of the European Parliament and of the Council (3) and has identified the need to update its provisions to improve its effectiveness.

(3)

It is appropriate to replace Regulation (EC) No 1222/2009 in order to clarify and update some of its provisions, taking into account technological progress with regard to tyres.

(4)

The transport sector accounts for a third of the Union’s energy consumption. Road transport was responsible for about 22 % of the Union’s total greenhouse gas emissions in 2015. Tyres, mainly because of their rolling resistance, account for 20 to 30 % of the fuel consumption of vehicles. A reduction in the rolling resistance of tyres would therefore contribute significantly to the fuel efficiency of road transport and thus to the reduction of greenhouse gas emissions and to the decarbonisation of the transport sector.

(5)

In order to meet the challenge of reducing the CO2 emissions of road transport, it is appropriate that Member States, in cooperation with the Commission, provide for incentives to innovate with regard to fuel‐efficient and safe C1 tyres, C2 tyres and C3 tyres.

(6)

Tyres are characterised by a number of interrelated parameters. Improving one parameter, such as rolling resistance, may have an adverse impact on other parameters, such as wet grip, while improving wet grip performance may have an adverse impact on external rolling noise. Tyre manufacturers should be encouraged to optimise all parameters beyond the current standards.

(7)

Fuel‐efficient tyres can be cost‐effective, since the fuel savings that they generate more than offset the increased purchase price resulting from the higher production costs of such tyres.

(8)

Regulation (EC) No 661/2009 of the European Parliament and of the Council (4) lays down minimum requirements for the rolling resistance of tyres. Technological developments make it possible to reduce the energy losses that are due to tyre rolling resistance significantly beyond those minimum requirements. To reduce the environmental impact of road transport, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase more fuel‐efficient tyres by providing them with harmonised information on the rolling resistance parameter.

(9)

Improving the labelling of tyres will enable consumers to obtain more relevant and more comparable information on fuel efficiency, safety and noise and to take cost‐effective and environmentally friendly decisions when purchasing tyres.

(10)

Traffic noise is a significant nuisance and has a harmful effect on health. Regulation (EC) No 661/2009 lays down minimum requirements for the external rolling noise of tyres. Technological developments make it possible to reduce external rolling noise significantly beyond those minimum requirements. To reduce traffic noise, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase tyres with lower external rolling noise by providing them with harmonised information on the external rolling noise parameter.

(11)

The provision of harmonised information on external rolling noise also facilitates the implementation of measures to limit traffic noise and contributes to increased awareness of the effect of tyres on traffic noise within the framework of Directive 2002/49/EC of the European Parliament and of the Council (5).

(12)

Regulation (EC) No 661/2009 also lays down minimum requirements for the wet grip of tyres. Technological developments make it possible to improve wet grip significantly beyond those minimum requirements, and thus to reduce wet braking distances. To improve road safety, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase tyres with higher wet grip performance by providing them with harmonised information on the wet grip parameter.

(13)

In order to ensure alignment with the international framework, Regulation (EC) No 661/2009 refers to Regulation No 117 of the Economic Commission for Europe of the United Nations (UNECE) (6), which sets out the relevant measurement methods for the rolling resistance, external rolling noise, and wet and snow grip performance of tyres.

(14)

Information on the performance of tyres that are specifically designed for use in severe snow and ice conditions should be included on the tyre label. Information on snow grip performance should be based on Regulation No 117 of the Economic Commission for Europe of the United Nations (UNECE), in its most up‐to‐date version applicable to the Union, (UNECE Regulation No 117), and the ‘Alpine Symbol’ pictogram contained therein should be included on the tyre label of a tyre which satisfies the minimum snow grip index values set out in that Regulation. Information on ice grip performance should, once the standard is formally adopted, be based on ISO standard ISO 19447 and the ice grip pictogram should be included on the tyre label of a tyre which satisfies the minimum ice grip index values set out in that ISO standard. Until adoption of ISO standard ISO 19447, ice grip performance should be assessed against reliable, accurate and reproducible methods, which take into account the generally recognised state of the art. The tyre label of a tyre which satisfies the minimum ice grip performance standards should show the ice grip pictogram set out in Annex I.

(15)

The abrasion of tyres during use is a significant source of microplastics, which are harmful to the environment and human health. The Commission’s Communication ‘A European Strategy for Plastics in a Circular Economy’ therefore mentions the need to address the unintentional release of microplastics from tyres, inter alia through information measures such as labelling and through minimum requirements for tyres. Linked to tyre abrasion is the concept of mileage, namely the number of kilometres a tyre will last before it needs to be replaced because of tread wear. In addition to tyre abrasion and tread wear, the lifespan of a tyre depends on a range of factors, such as the wear resistance of the tyre, including the compound, tread pattern and structure, road conditions, maintenance, tyre pressure and driving behaviour.

(16)

However, a suitable testing method to measure tyre abrasion and mileage is not currently available. Therefore, the Commission should mandate the development of such a testing method, taking into full consideration the state of the art and internationally developed or proposed standards and regulations, as well as the work carried out by industry.

(17)

Re‐treaded tyres constitute a substantial part of the market for heavy‐duty vehicle tyres. The re‐treading of tyres extends their lifespan and contributes to circular economy objectives, such as waste reduction. Applying labelling requirements to such tyres would bring substantial energy savings. This Regulation should provide for the future inclusion of a suitable testing method to measure the performance of re‐treaded tyres, which is not currently available.

(18)

The energy label provided for under Regulation (EU) 2017/1369 of the European Parliament and of the Council (7), which ranks the energy consumption of products on a scale from ‘A’ to ‘G’, is recognised by over 85 % of Union consumers as a clear and transparent information tool and has proven to be effective in promoting more efficient products. The tyre label should be of the same design to the extent possible, while recognising the specificities of tyre parameters.

(19)

The provision of comparable information on tyre parameters in the form of a standard tyre label is likely to influence purchasing decisions by end-users in favour of more fuel‐efficient, longer‐lasting, safer and quieter tyres. This, in turn, is likely to encourage tyre manufacturers to optimise tyre parameters, which would pave the way for a more sustainable consumption and production of tyres.

(20)

The need for greater information on fuel efficiency and other parameters is relevant for all end-users, including purchasers of replacement tyres, purchasers of tyres fitted on new vehicles, and fleet managers and transport undertakings, who cannot easily compare the parameters of different tyre brands in the absence of a labelling and harmonised testing regime. It is therefore appropriate to require that a tyre label be provided for all tyres offered with or fitted on vehicles.

(21)

Currently, tyre labels are required for tyres for cars (C1 tyres) and vans (C2 tyres) but not for heavy‐duty vehicles (C3 tyres). C3 tyres consume more fuel and cover more kilometres per year than C1 tyres or C2 tyres, and therefore the potential to reduce fuel consumption and greenhouse gas emissions from heavy‐duty vehicles is significant. Therefore, C3 tyres should be included in the scope of this Regulation. Including C3 tyres fully in the scope of this Regulation is also in line with Regulation (EU) 2018/956 of the European Parliament and of the Council (8), which provides for the monitoring and reporting of CO2 emissions from and fuel consumption of new heavy‐duty vehicles, and with Regulation (EU) 2019/1242 of the European Parliament and of the Council (9), which sets CO2 emission performance standards for new heavy‐duty vehicles.

(22)

Many end-users make tyre purchasing decisions without seeing the actual tyre and therefore do not see the tyre label affixed to it. In such situations, end-users should be shown the tyre label before taking their purchasing decisions. The display of a tyre label on tyres at the point of sale, as well as in technical promotional material, should ensure that distributors as well as potential end-users receive harmonised information on the relevant tyre parameters at the time and place of the purchasing decision.

(23)

Some end-users make tyre purchasing decisions before arriving at the point of sale, or purchase tyres by mail order or on the internet. To ensure that those end-users can also make an informed choice on the basis of harmonised information on, inter alia, fuel efficiency, wet grip and external rolling noise, tyre labels should be displayed in all technical promotional material and visual advertisements for specific tyre types, including where such material is made available on the internet. Where visual advertisements pertain to a tyre family, and not only to a specific tyre type, the tyre label does not have to be shown.

(24)

Potential end-users should be provided with information explaining each component of the tyre label and its relevance. That information should be provided in all technical promotional material, for example on suppliers’ websites, but should not be required in visual advertisements. Technical promotional material should not be understood to include advertisements via billboards, newspapers, magazines or radio or television broadcasts.

(25)

Without prejudice to the market surveillance obligations of Member States or to the obligation of suppliers to check product conformity, suppliers should make the requisite product compliance information electronically available in the product database. The information that is relevant to consumers and distributors should be made publicly available in the public part of the product database. That information should be made available as open data so as to give mobile application developers and comparison tools the opportunity to use it. Easy direct access to the public part of the product database should be facilitated by user‐oriented tools that are included on the printed tyre label, such as a dynamic quick response code (QR code).

(26)

The compliance part of the product database should be subject to strict data protection rules. The required specific parts of the technical documentation in the compliance part of the product database should be made available both to market surveillance authorities and to the Commission. Where technical information is too sensitive to include it in the category of technical documentation, market surveillance authorities should have access to that information when necessary in accordance with the duty of cooperation on suppliers or by way of additional parts of the technical documentation uploaded to the product database by suppliers on a voluntary basis.

(27)

The sale of tyres through internet sales platforms, rather than directly from suppliers, is growing. Therefore, hosting service providers should enable the display of the tyre label and product information sheet provided by the supplier close to the price indication. They should inform the distributor of the obligation to display the tyre label and product information sheet, but should not be responsible for the accuracy or content of that tyre label or product information sheet. The obligations imposed on hosting service providers under this Regulation should remain limited to what is reasonable and should not amount to a general obligation to monitor the information that they store or to actively seek facts or circumstances indicating activities that do not comply with the requirements of this Regulation. However, Article 14(1) of Directive 2000/31/EC of the European Parliament and of the Council (10) requires hosting service providers that wish to benefit from the liability exemption contained in that provision to act expeditiously to remove or disable access to information that they store at the request of recipients of their services where such information does not comply with the requirements of this Regulation, such as those relating to missing, incomplete or incorrect tyre labels or product information sheets. They should do so as soon as they obtain actual knowledge of such information or, as regards claims for damages, as soon as they become aware of such information, for example through specific information provided by a market surveillance authority. Suppliers selling directly to end-users via their own website are subject to the same distance selling obligations as distributors.

(28)

Rolling resistance, wet grip, external rolling noise and other parameters should be measured in accordance with reliable, accurate and reproducible methods that take into account the generally recognised state‐of‐the‐art measurement and calculation methods. As far as possible, such methods should reflect average consumer behaviour and be robust in order to deter both intentional and unintentional circumvention. Tyre labels should reflect the comparative performance of the tyres in actual use, within the constraints arising from the need for reliable, accurate and reproducible laboratory testing, in order to enable end-users to compare different tyres and to limit testing costs for manufacturers.

(29)

Where they have sufficient reason to believe that a supplier has not ensured the accuracy of the tyre label and in order to give additional confidence to consumers, national authorities as defined in point (37) of Article 3 of Regulation (EU) 2018/858 of the European Parliament and of the Council (11) should check whether the classes for rolling resistance, wet grip and external rolling noise displayed on the tyre label, as well as the pictograms for other parameters, correspond to the documentation provided by the supplier based on test results and calculations. Such checks may take place during the type‐approval process and do not necessarily require the physical testing of the tyre.

(30)

Compliance by suppliers, wholesalers, dealers and other distributors with the provisions on the labelling of tyres is essential in order to ensure a level playing field in the Union. Member States should therefore monitor such compliance through regular ex‐post controls and market surveillance in accordance with Regulation (EU) 2019/1020 of the European Parliament and of the Council (12).

(31)

In order to facilitate the monitoring of compliance, to provide a useful tool to end-users and to allow alternative ways for distributors to receive product information sheets, tyres should be included in the product database established under Regulation (EU) 2017/1369. That Regulation should therefore be amended accordingly.

(32)

In order for end-users to have confidence in the tyre label, other labels that mimic the tyre label should not be allowed. For the same reason, other labels, marks, symbols or inscriptions that are likely to mislead or confuse end-users with respect to the parameters covered by the tyre label should not be allowed.

(33)

The penalties applicable to infringements of this Regulation and of the delegated acts adopted pursuant thereto should be effective, proportionate and dissuasive.

(34)

In order to promote energy efficiency, climate change mitigation, road safety and environmental protection, Member States should be able to create incentives for the use of energy‐efficient and safe tyres. Member States are free to decide on the nature of such incentives. Such incentives should comply with Union State aid rules and should not constitute unjustifiable market barriers. This Regulation does not prejudice the outcome of any State aid procedures that may be undertaken in accordance with Articles 107 and 108 of the Treaty on the Functioning of the European Union (TFEU) in respect of such incentives.

(35)

In order to amend the content and format of the tyre label, to introduce requirements with respect to re‐treaded tyres, tyre abrasion and mileage, and to adapt the Annexes to technological progress, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law‐Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(36)

Once reliable, accurate and reproducible methods to test and measure tyre abrasion and mileage are available, the Commission should assess the feasibility of adding information on tyre abrasion and mileage to the tyre label. When proposing a delegated act to add tyre abrasion and mileage to the tyre label, the Commission should take that assessment into account, and should collaborate closely with industry, relevant standardisation organisations, such as the European Committee for Standardization (CEN), the United Nations Economic Commission for Europe (UNECE) or the International Organisation for Standardisation (ISO), and representatives of other stakeholders interested in the development of suitable testing methods. Information on tyre abrasion and mileage should be unambiguous and should not negatively affect the clear intelligibility and effectiveness of the tyre label as a whole towards end-users. Such information would also enable end-users to make an informed choice with regard to tyres, their lifespan and the unintentional release of microplastics. This would help protect the environment and at the same time allow end-users to estimate the operating costs of tyres over a longer period.

(37)

Tyres which were already placed on the market before the date of application of this Regulation should not need to be provided with a new tyre label.

(38)

The size of the tyre label should remain the same as that set out in Regulation (EC) No 1222/2009. Details regarding snow grip and ice grip, and the QR code, should be included on the tyre label.

(39)

The Commission should carry out an evaluation of this Regulation. In accordance with paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law‐Making, that evaluation should be based on efficiency, effectiveness, relevance, coherence and value added and should provide the basis for impact assessments of options for further action.

(40)

Since the objective of this Regulation, namely to increase safety, the protection of health, and the economic and environmental efficiency of road transport by providing information to end-users to allow them to choose more fuel‐efficient, longer‐lasting, safer and quieter tyres, cannot be sufficiently achieved by the Member States because it requires harmonised information for end-users, but can rather, by reason of the need for a harmonised regulatory framework and a level playing field for manufacturers, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). A Regulation remains the appropriate legal instrument as it imposes clear and detailed rules which preclude divergent transposition by Member States and thus ensures a higher degree of harmonisation across the Union. A harmonised regulatory framework at Union rather than at Member State level reduces costs for suppliers, ensures a level playing field and ensures the free movement of goods across the internal market. In accordance with the principle of proportionality, as set out in Article 5 TEU, this Regulation does not go beyond what is necessary in order to achieve that objective.

(41)

Regulation (EC) No 1222/2009 should therefore be repealed with effect from the date of the application of this Regulation,

(1)

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

(2)

The Union’s ability to respond to the increasing pressures on water resources could be improved by wider reuse of treated waste water, limiting extraction from surface water bodies and groundwater bodies, reducing the impact of discharge of treated waste water into water bodies, and promoting water savings through multiple uses for urban waste water, while ensuring a high level of environmental protection. Directive 2000/60/EC of the European Parliament and of the Council (4) mentions water reuse, in combination with the promotion of the use of water-efficient technologies in industry and water-saving irrigation techniques, as one of the supplementary measures Member States may choose to apply to achieve that Directive’s objectives of good qualitative and quantitative water status for surface water bodies and groundwater bodies. Council Directive 91/271/EEC (5) requires that treated waste water be reused whenever appropriate.

(3)

The communication of the Commission of 14 November 2012‘A Blueprint to Safeguard Europe’s Water Resources’ points to the need to create an instrument to regulate standards at Union level for water reuse, in order to remove the obstacles to a widespread use of such an alternative water supply option, namely one that can help to reduce water scarcity and lessen the vulnerability of supply systems.

(4)

The communication of the Commission of 18 July 2007‘Addressing the challenge of water scarcity and droughts in the European Union’ sets out the hierarchy of measures that Member States should consider in managing water scarcity and droughts. It states that in regions where all preventive measures have been implemented according to the water hierarchy and where demand for water still exceeds availability, additional water supply infrastructure can in some circumstances, and taking due account of the cost-benefit dimension, serve as an alternative approach to mitigate the impacts of severe drought.

(5)

In its resolution of 9 October 2008 on addressing the challenge of water scarcity and droughts in the European Union (6), the European Parliament recalls that a demand-side approach should be preferred when managing water resources, but considers that the Union should adopt a holistic approach when managing water resources, combining measures of demand management, measures to optimise existing resources within the water cycle and measures to create new resources, and that the approach needs to integrate environmental, social and economic considerations.

(6)

In its communication of 2 December 2015‘Closing the loop – An EU action plan for the Circular Economy’, the Commission committed to taking a series of actions to promote the reuse of treated waste water, including the development of a legislative proposal on minimum requirements for water reuse. The Commission should update its action plan and keep water resources as a priority area in which to intervene.

(7)

The purpose of this Regulation is to facilitate the uptake of water reuse whenever it is appropriate and cost-efficient, thereby creating an enabling framework for those Member States who wish or need to practise water reuse. Water reuse is a promising option for many Member States, but currently only a small number of them practice water reuse and have adopted national legislation or standards in that regard. This Regulation should be flexible enough to allow the continuation of the practice of water reuse and at the same time to ensure that it is possible for other Member States to apply those rules when they decide to introduce this practice at a later stage. Any decision not to practise water reuse should be duly justified based on the criteria laid down in this Regulation and reviewed regularly.

(8)

Directive 2000/60/EC provides Member States with the necessary flexibility to include supplementary measures in the programmes of measures that they adopt to support their efforts to achieve the water quality objectives established by that Directive. The non-exclusive list of supplementary measures provided for in Part B of Annex VI to Directive 2000/60/EC contains, among others, water reuse measures. In this context and in line with a hierarchy of measures that could be considered by the Member States in managing water scarcity and droughts and that encourages measures ranging from water saving to water pricing policy and alternative solutions, and taking due account of the cost-benefit dimension, the minimum requirements for water reuse, as established by this Regulation, should be applicable whenever treated urban waste water from urban waste water treatment plants is reused, in accordance with Directive 91/271/EEC, for agricultural irrigation.

(9)

Reuse of properly treated waste water, for example from urban waste water treatment plants, is considered to have a lower environmental impact than other alternative water supply methods, such as water transfers or desalination. However, such water reuse, which could reduce water wastage and save water, is practised only to a limited extent in the Union. This appears to be partly due to the significant cost of waste water reuse systems and the lack of common Union environmental and health standards for water reuse, and, as regards, in particular, agricultural products, due to the potential health and environmental risks and potential obstacles to the free movement of such products which have been irrigated with reclaimed water.

(10)

Health standards in relation to food hygiene for agricultural products irrigated with reclaimed water can be achieved only if quality requirements for reclaimed water intended for agricultural irrigation do not differ significantly between the Member States. Harmonisation of requirements would also contribute to the efficient functioning of the internal market in relation to such products. It is therefore appropriate to introduce minimum levels of harmonisation by setting minimum requirements for water quality and monitoring. Those minimum requirements should consist of minimum parameters for reclaimed water that are based on the technical reports of the Commission’s Joint Research Centre and reflect international standards on water reuse, and other stricter or additional quality requirements imposed, if necessary, by competent authorities together with any relevant preventive measures.

(11)

Water reuse for agricultural irrigation can also contribute to the promotion of the circular economy by recovering nutrients from the reclaimed water and applying them to crops, by means of fertigation techniques. Thus, water reuse could potentially reduce the need for supplemental applications of mineral fertiliser. End-users should be informed about the nutrient content of reclaimed water.

(12)

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

(13)

The high investment needed to upgrade urban waste water treatment plants and the lack of financial incentives for practising water reuse in agriculture have been identified as being among the reasons for the low uptake of water reuse in the Union. It should be possible to address those issues by promoting innovative schemes and economic incentives to appropriately take account of the costs and the socioeconomic and environmental benefits of water reuse.

(14)

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

(15)

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

(16)

Risk management should comprise the identification and management of risks in a proactive way, and should incorporate the concept of producing reclaimed water of a specific quality required for particular uses. Risk assessment should be based on key elements of risk management and should identify any additional water quality requirements necessary to ensure sufficient protection of the environment and of human and animal health. For that purpose, water reuse risk management plans should ensure that reclaimed water is safely used and managed and that there are no risks to the environment or to human or animal health. In order to develop such risk management plans, 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 World Health Organisation (WHO) guidelines could be used.

(17)

The quality requirements for water intended for human consumption are laid down in Council Directive 98/83/EC (7). Member States should take appropriate measures to ensure that water reuse activities do not lead to a deterioration in the quality of water intended for human consumption. For that reason, the water reuse risk management plan should pay special attention to the protection of water bodies used for the abstraction of water intended for human consumption and relevant safeguard zones.

(18)

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

(19)

In order to effectively protect the environment and human and animal health, reclamation facility operators should be primarily responsible for the quality of reclaimed water at the point of compliance. For the purposes of compliance with the minimum requirements laid down under this Regulation and with any additional conditions set by the competent authority, reclamation facility operators should monitor the quality of reclaimed water. It is therefore appropriate to establish the minimum requirements for monitoring, consisting of the frequencies of the routine monitoring and the timing and performance targets for validation monitoring. Certain requirements for routine monitoring are provided for in Directive 91/271/EEC.

(20)

This Regulation should cover reclaimed water which is obtained from waste water that has been collected in collecting systems, that has been treated in urban waste water treatment plants in accordance with Directive 91/271/EEC and that undergoes further treatment, either in the urban waste water treatment plant or in a reclamation facility, in order to meet the parameters set out in Annex I to this Regulation. In accordance with Directive 91/271/EEC, agglomerations of less than 2 000 population equivalent (p.e.) do not have to be provided with a collecting system. However, urban waste water from agglomerations of less than 2 000 p.e. that enters a collecting system should be subject to appropriate treatment before being discharged into fresh water or estuaries, in accordance with Directive 91/271/EEC. In that context, waste water from agglomerations of less than 2 000 p.e. should fall under the scope of this Regulation only when it enters a collecting system and is subject to treatment in an urban waste water treatment plant. Similarly, this Regulation should not concern biodegradable industrial waste water from plants belonging to the industrial sectors listed in Annex III to Directive 91/271/EEC, unless the waste water from those plants enters a collecting system and is subject to treatment in an urban waste water treatment plant.

(21)

The reuse of treated urban waste water for agricultural irrigation is a market-driven action, based on the demands and needs of the agricultural sector, in particular in certain Member States that face water resource shortages. The reclamation facility operators and the end-users should cooperate to ensure that reclaimed water produced in accordance with the minimum quality requirements established by this Regulation meets the needs of the end-users regarding crop categories. In cases where the quality classes of the water produced by the reclamation facility operators are not compatible with the crop category and irrigation method already in place in the area served, for example in a collective supply system, water quality requirements could be met by using, at a subsequent stage, several water treatment options alone or in combination with non-treatment options for the reclaimed water, in line with the multi-barrier approach.

(22)

In order to ensure optimal reuse of urban waste water resources, end-users should receive training to ensure that they use water of the appropriate reclaimed water quality class. Where the destination of a specific type of crop is unknown or where it has multiple destinations, reclaimed water of the highest quality class should be used, unless appropriate barriers are applied which enable the required quality to be achieved.

(23)

It is necessary to ensure that the use of reclaimed water is safe, thereby encouraging water reuse at Union level and enhancing public confidence in it. Production and supply of reclaimed water for agricultural irrigation should therefore only be permitted on the basis of a permit, granted by competent authorities of Member States. In order to ensure a harmonised approach at Union level, traceability of reclaimed water and transparency, the substantive rules for such permits should be laid down at Union level. However, the details of the procedures for granting permits, such as the designation of the competent authorities and deadlines, should be determined by Member States. Member States should be able to apply existing procedures for granting permits, which should be adapted to take account of the requirements introduced by this Regulation. When designating the parties responsible for the drawing up of the water reuse risk management plan and the competent authority for the granting of the permit for production and supply of reclaimed water, Member States should ensure that there is no conflict of interests.

(24)

If a reclaimed water distribution operator and a reclaimed water storage operator are needed, it should be possible to require such operators to have a permit. If all requirements for the permit are met, the competent authority in the Member State should grant a permit containing all the necessary conditions and measures established in the water reuse risk management plan.

(25)

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

(26)

Competent authorities should verify compliance of reclaimed water with the conditions set out in the relevant permit. In cases of non-compliance, those authorities should require the responsible parties to take the necessary measures to ensure that the reclaimed water is in compliance. Supply of the reclaimed water should be suspended where non-compliance causes a significant risk to the environment or to human or animal health.

(27)

The provisions of this Regulation are intended to be complementary to the requirements of other Union legislation, in particular with regard to possible health and environmental risks. In order to ensure a holistic approach to addressing possible risks to the environment and to human and animal health, the reclamation facility operators and competent authorities should take into account the requirements laid down in other relevant Union legislation, in particular Council Directives 86/278/EEC (8) and 91/676/EEC (9), Directives 91/271/EEC, 98/83/EC and 2000/60/EC, Regulations (EC) No 178/2002 (10), (EC) No 852/2004 (11), (EC) No 183/2005 (12), (EC) No 396/2005 (13) and (EC) No 1069/2009 (14) of the European Parliament and of the Council, Directives 2006/7/EC (15), 2006/118/EC (16), 2008/105/EC (17) and 2011/92/EU (18) of the European Parliament and of the Council, and Commission Regulations (EC) No 2073/2005 (19), (EC) No 1881/2006 (20) and (EU) No 142/2011 (21).

(28)

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

(29)

There is great potential for the recycling and reuse of treated waste water. With a view to promoting and encouraging water reuse, the indication of specific uses within this Regulation should not preclude Member States from allowing the use of reclaimed water for other purposes, including industrial, amenity-related and environmental purposes, as considered necessary in the light of national circumstances and needs, provided a high level of protection of the environment and of human and animal health is ensured.

(30)

Competent authorities should cooperate with other relevant authorities, through the exchange of information, in order to ensure compliance with relevant Union and national requirements.

(31)

In order to increase confidence in water reuse, information should be provided to the public. Making available clear, comprehensive and updated information on water reuse would allow for increased transparency and traceability and could also be of particular use to other relevant authorities for whom the specific water reuse has implications. In order to encourage water reuse and with a view to making stakeholders aware of the benefits of water reuse and thereby promoting acceptance, Member States should ensure that information and awareness-raising campaigns, adapted to the scale of water reuse, are developed.

(32)

End-user education and training are of primary importance as components of implementing and maintaining preventive measures. Specific human exposure preventive measures should be considered in the water reuse risk management plan, such as use of personal protective equipment, handwashing and personal hygiene.

(33)

Directive 2003/4/EC of the European Parliament and of the Council (22) aims to guarantee the right of access to environmental information in the Member States in line with the Convention on access to information, public participation in decision-making and access to justice in environmental matters (23) (the Aarhus Convention). Directive 2003/4/EC lays down extensive obligations related both to making environmental information available upon request and actively disseminating such information. Directive 2007/2/EC of the European Parliament and of the Council (24) covers the sharing of spatial information, including data sets on different environmental topics. It is important that provisions of this Regulation related to access to information and data-sharing arrangements complement those Directives and do not create a separate legal regime. Therefore, the provisions of this Regulation on information to the public and on information about monitoring of implementation should be without prejudice to Directives 2003/4/EC and 2007/2/EC.

(34)

Data provided by Member States are essential to enable the Commission to monitor and assess this Regulation in relation to the objectives it pursues.

(35)

Pursuant to paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (25), the Commission should carry out an evaluation of this Regulation. The evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and Union value added and should provide the basis for impact assessments of possible further measures. The evaluation should take into account scientific progress, in particular as regards the potential impact of substances of emerging concern.

(36)

The minimum requirements for the safe reuse of treated urban waste water reflect available scientific knowledge and internationally recognised water reuse standards and practices and guarantee that such water can be safely used for agricultural irrigation, thereby ensuring a high level of protection of the environment and of human and animal health. In light of the results of the evaluation of this Regulation or whenever new scientific developments and technical progress so require, the Commission should be able to examine the need to review the minimum requirements set out in Section 2 of Annex I and, where appropriate, should submit a legislative proposal to amend this Regulation.

(37)

In order to adapt the key elements of risk management to technical and scientific progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the key elements of risk management provided for in this Regulation. Moreover, in order to ensure a high level of protection of the environment and of human and animal health, the Commission should also be able to adopt delegated acts supplementing the key elements of risk management provided for in this Regulation by laying down technical specifications. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(38)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission for the adoption of detailed rules regarding the format and presentation of the information relating to monitoring of the implementation of this Regulation to be provided by the Member States and regarding the format and presentation of the Union-wide overview drawn up by the European Environment Agency. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (26).

(39)

The aim of this Regulation is, inter alia, to protect the environment and human and animal health. As the Court of Justice has held on numerous occasions, it would be incompatible with the binding effect which the third paragraph of Article 288 of the Treaty on the Functioning of the European Union ascribes to a Directive, to exclude, in principle, the possibility of an obligation imposed by a Directive from being relied on by persons concerned. That consideration also applies in respect of a Regulation which has as its objective to guarantee that reclaimed water is safe for agricultural irrigation.

(40)

Member States should 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.

(41)

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

(42)

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

(43)

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

(44)

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

(1)

In accordance with Council Decision (EU) 2019/1918 (2), the Agreement in the form of an Exchange of Letters concerning the extension of the Protocol setting out the fishing opportunities and financial contribution provided for in the Fisheries Partnership Agreement between the European Community and the Islamic Republic of Mauritania, expiring on 15 November 2019 (‘the Agreement in the form of an Exchange of Letters’), was signed on 13 November 2019.

(2)

The objective of the Agreement in the form of an Exchange of Letters is to enable the European Union and the Islamic Republic of Mauritania to continue to work together on promoting a sustainable fisheries policy and the sound exploitation of fisheries resources in Mauritanian waters and to allow Union vessels to carry out their fishing activities in those waters.

(3)

The Agreement in the form of an Exchange of Letters should be approved,