# Directive 2013/39/EU of the European Parliament and of the CouncilShow full title

Directive 2013/39/EU of the European Parliament and of the Council of 12 August 2013 amending Directives 2000/60/EC and 2008/105/EC            as regards priority substances in the field of water policy (Text with EEA relevance)         

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# Directive 2013/39/EU of the European Parliament and of the Council

# of 12 August 2013

# amending Directives 2000/60/EC and 2008/105/EC as regards priority substances in the field of water policy

# (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the European Commission,

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

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

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

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

Whereas:

(1)Chemical pollution of surface water poses a threat to the aquatic environment, with effects such as acute and chronic toxicity                              in aquatic organisms, accumulation of pollutants in the ecosystem and loss of habitats and biodiversity, and also poses a                              threat to human health. As a matter of priority, causes of pollution should be identified and emissions of pollutants should                              be dealt with at source, in the most economically and environmentally effective manner.

(2)Pursuant to the second sentence of Article 191(2) of the Treaty on the Functioning of the European Union (TFEU), Union policy                              on the environment is to be based on the precautionary principle and on the principles that preventive action should be taken,                              that environmental damage should, as a priority, be rectified at source and that the polluter should pay.

(3)Treating waste water can be very costly. In order to facilitate cheaper and more cost effective treatment, the development                              of innovative water treatment technologies could be stimulated.

(4)Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community                              action in the field of water policy(4) lays down a strategy against the pollution of water. That strategy involves the identification of priority substances amongst                              those that pose a significant risk to, or via, the aquatic environment at Union level. Decision No 2455/2001/EC of the European                              Parliament and of the Council of 20 November 2001 establishing the list of priority substances in the field of water policy(5) set out the first list of 33 substances or groups of substances that were prioritised at Union level for inclusion in Annex                              X to Directive 2000/60/EC.

(5)Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards                              in the field of water policy(6) lays down environmental quality standards (EQS), in accordance with Directive 2000/60/EC, for the 33 priority substances                              identified in Decision No 2455/2001/EC and eight other pollutants that were already regulated at Union level.

(6)Pursuant to Article 191(3) TFEU, in preparing its policy on the environment, the Union is to take account of available scientific                              and technical data, environmental conditions in the various regions of the Union, the potential benefits and costs of action                              or lack of action as well as the economic and social development of the Union as a whole and the balanced development of its                              regions. Scientific, environmental and socio-economic factors, including human health considerations, should be taken into                              account in developing a cost-effective and proportionate policy on the prevention and control of chemical pollution of surface                              waters, including in reviewing the list of priority substances in accordance with Article 16(4) of Directive 2000/60/EC. In                              view of that aim, the polluter pays principle underpinning Directive 2000/60/EC should be consistently applied.

(7)The Commission has conducted a review of the list of priority substances in accordance with Article 16(4) of Directive 2000/60/EC                              and with Article 8 of Directive 2008/105/EC and has come to the conclusion that it is appropriate to amend the list of priority                              substances by identifying new substances for priority action at Union level, setting EQS for those newly identified substances,                              revising the EQS for some existing substances in line with scientific progress and setting biota EQS for some existing and                              newly identified priority substances.

(8)The review of the priority substances list has been supported by an extensive consultation with experts from the Commission                              services, Member States, stakeholders and the Scientific Committee on Health and Environmental Risks.

(9)The revised EQS for existing priority substances should be taken into account for the first time in river basin management                              plans covering the period 2015 to 2021. The newly identified priority substances and their EQS should be taken into account                              in the establishment of supplementary monitoring programmes and in preliminary programmes of measures to be submitted by the                              end of 2018. With the aim of achieving good surface water chemical status, the revised EQS for existing priority substances                              should be met by the end of 2021 and the EQS for newly identified priority substances by the end of 2027, without prejudice                              to Article 4(4) to (9) of Directive 2000/60/EC, which includes inter alia provisions for extending the deadline for achieving                              good surface water chemical status or achieving less stringent environmental objectives for specific bodies of water on the                              grounds of disproportionate cost and/or socio-economic need, provided that no further deterioration occurs in the status of                              the affected bodies of water. The determination of surface water chemical status by the 2015 deadline laid down in Article                              4 of Directive 2000/60/EC should be based, therefore, only on the substances and EQS set out in Directive 2008/105/EC in the                              version in force on 13 January 2009 unless those EQS are stricter than the revised EQS under this Directive, in which case                              the latter should be applied.

(10)Since the adoption of Directive 2000/60/EC, numerous Union acts have been adopted, in accordance with Article 16(6) of that                              Directive, which constitute emission controls for individual priority substances. Moreover, many environmental protection                              measures fall under the scope of other existing Union law. Where the objectives laid down in Article 16(1) of Directive 2000/60/EC                              can be effectively achieved by existing instruments, priority should be given to implementing and revising those instruments                              rather than establishing new measures. The inclusion of a substance in Annex X to Directive 2000/60/EC is without prejudice                              to the application of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning                              the placing of plant protection products on the market(7).

(11)In order to improve coordination between Directive 2000/60/EC, Regulation (EC) No 1907/2006 of the European Parliament and                              of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),                              establishing a European Chemicals Agency(8), and relevant sectoral legislation, potential synergies should be explored with a view to identifying possible areas where                              data gathered through implementation of Directive 2000/60/EC can be used to support REACH and other relevant substance evaluation                              procedures and, conversely, areas where data generated for the purpose of substance evaluations under REACH and relevant sectoral                              legislation can be used to support the implementation of Directive 2000/60/EC, including the prioritisation outlined in Article                              16(2) of that Directive.

(12)The progressive reduction of pollution from priority substances and the cessation or phasing-out of discharges, emissions                              and losses of priority hazardous substances, as required by Directive 2000/60/EC, may often be achieved most cost-effectively                              through Union substance-specific measures at source, for example pursuant to Regulations (EC) No 1907/2006, (EC) No 1107/2009,                              (EU) No 528/2012(9) or Directives 2001/82/EC(10), 2001/83/EC(11) or 2010/75/EU(12). Coherence between those legal acts, Directive 2000/60/EC and other relevant legislation should therefore be strengthened                              to ensure that source-control mechanisms are applied as appropriate. Where the outcome of the regular review of Annex X to                              Directive 2000/60/EC, and available monitoring data, show that the measures in place at Union or Member State level are insufficient                              to achieve the EQS for certain priority substances or the cessation or phasing-out objective for certain priority hazardous                              substances, appropriate action should be taken at Union or Member State level with a view to achieving the objectives of Directive                              2000/60/EC, taking into account the risk evaluations, socio-economic and cost-benefit analyses carried out under the relevant                              legislation as well as the availability of alternatives.

(13)Since the derivation of the EQS for the 33 priority substances included in Annex X to Directive 2000/60/EC, a number of risk                              assessments under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing                              substances(13), later replaced by Regulation (EC) No 1907/2006, have been concluded. In order to ensure an appropriate level of protection                              and to update EQS in line with the latest scientific and technical knowledge concerning risks to, or via, the aquatic environment,                              the EQS for some of the existing substances should be revised.

(14)Additional substances posing a significant risk to, or via, the aquatic environment at Union level have been identified and                              prioritised using the approaches specified in Article 16(2) of Directive 2000/60/EC and should be added to the list of priority                              substances. The latest available scientific and technical information has been taken into account in deriving the EQS for                              those substances.

(15)The contamination of water and soil with pharmaceutical residues is an emerging environmental concern. In evaluating and controlling                              the risk to, or via, the aquatic environment from medicinal products, adequate attention should be paid to Union environmental                              objectives. In order to address that concern, the Commission should study the risks of environmental effects from medicinal                              products and provide an analysis of the relevance and effectiveness of the current legislative framework in protecting the                              aquatic environment and human health via the aquatic environment.

(16)The derivation of EQS for priority hazardous substances usually involves higher levels of uncertainty than is the case for                              priority substances but such EQS still establish a benchmark to assess compliance with the objective of good surface water                              chemical status, as defined in Article 2(24) and points (ii) and (iii) of point (a) of Article 4(1) of Directive 2000/60/EC.                              However, in order to ensure an adequate level of protection for the environment and human health, the cessation or phasing-out                              of discharges, emissions and losses of priority hazardous substances should also be aimed at, in accordance with point (iv)                              of point (a) of Article 4(1) of Directive 2000/60/EC.

(17)Scientific knowledge about the fate and effects of pollutants in water has evolved significantly over recent years. More is                              known about which compartment of the aquatic environment (water, sediment or biota, hereinafter ‘matrix’) a substance is likely                              to be found in, and therefore where its concentration is most likely to be measurable. Some very hydrophobic substances accumulate                              in biota and are hardly detectable in water even using the most advanced analytical techniques. For such substances, EQS should                              be set for biota. Nevertheless, in order to take advantage of their monitoring strategy and adapt it to their local circumstances,                              Member States should have flexibility to apply an EQS for an alternative matrix or, where relevant, an alternative biota taxon,                              for example sub-phylum Crustacea, paraphylum ‘fish’, class Cephalopoda or class Bivalvia (mussels and clams), provided that                              the level of protection afforded by the EQS and the monitoring system applied by the Member States is as good as that provided                              by the EQS and matrix laid down in this Directive.

(18)Novel monitoring methods such as passive sampling and other tools show promise for future application, and their development                              should therefore be pursued.

(19)Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of the European Parliament and                              of the Council, technical specifications for chemical analysis and monitoring of water status(14), establishes minimum performance criteria for the analytical methods used in monitoring water status. Those criteria ensure                              meaningful and relevant monitoring information by requiring the use of analytical methods that are sensitive enough to ensure                              that any exceedance of an EQS can be reliably detected and measured. Member States should be permitted to monitor in matrices                              or in biota taxa other than those specified by this Directive only if the analytical method used meets the minimum performance                              criteria set out in Article 4 of Directive 2009/90/EC for the relevant EQS and matrix or biota taxon, or performs at least                              as well as the method available for the EQS and matrix or biota taxon specified in this Directive.

(20)The implementation of this Directive involves challenges which include the diversity of the possible solutions to scientific,                              technical and practical questions and the incomplete development of monitoring methods, as well as constraints on human and                              financial resources. To help address some of those challenges, the development of monitoring strategies and analytical methods                              should be supported by technical work by expert groups under the Common Implementation Strategy for Directive 2000/60/EC.

(21)Persistent, bioaccumulative and toxic substances (PBTs) and other substances that behave like PBTs can be found for decades                              in the aquatic environment at levels posing a significant risk, even if extensive measures to reduce or eliminate emissions                              of such substances have already been taken. Some are also capable of long-range transport and are largely ubiquitous in the                              environment. Several such substances are among the existing and newly identified priority hazardous substances. For some of                              those substances there is evidence of long-term ubiquity in the aquatic environment at Union level, and those particular substances                              therefore need special consideration as regards their impact on the presentation of chemical status under Directive 2000/60/EC                              and as regards monitoring requirements.

(22)As regards the presentation of chemical status under Section 1.4.3 of Annex V to Directive 2000/60/EC, Member States should                              be allowed to present separately the impact on chemical status of substances that behave like ubiquitous PBTs so that improvements                              in water quality achieved in relation to other substances are not obscured. In addition to the obligatory map covering all                              substances, additional maps, covering substances behaving like ubiquitous PBTs and separately covering the rest of the substances,                              could be provided.

(23)Monitoring should be adapted to the spatial and temporal scale of the expected variation in concentrations. Given the widespread                              distribution and long recovery times expected for substances behaving like ubiquitous PBTs, Member States should be allowed                              to reduce the number of monitoring sites and/or the frequency of monitoring for those substances to the minimum level sufficient                              for reliable long-term trend analysis, provided that a statistically robust monitoring baseline is available.

(24)The special consideration given to substances behaving like ubiquitous PBTs does not exempt the Union or the Member States                              from taking measures additional to those already taken, including at international level, to reduce or eliminate discharges,                              emissions and losses of those substances so as to achieve the objectives set out in point (a) of Article 4(1) of Directive                              2000/60/EC.

(25)Under Article 10(3) of Directive 2000/60/EC, where a quality objective or quality standard established pursuant to that Directive,                              to the Directives listed in Annex IX to Directive 2000/60/EC, or pursuant to any other Union legislation, requires stricter                              conditions than those which would result from the application of Article 10(2) of that Directive, more stringent emission                              controls are to be set accordingly. A similar provision has also been included in Article 18 of Directive 2010/75/EU. It follows                              from those Articles that the emission controls set under the legislation listed in Article 10(2) of Directive 2000/60/EC should                              be the minimum controls applied. Where those controls cannot ensure that an EQS is met, for example in the case of a substance                              behaving like a ubiquitous PBT, but stricter conditions would not either, even in conjunction with stricter conditions for                              other discharges, emissions and losses affecting the water body, such stricter conditions could not be considered as being                              required to meet that EQS.

(26)High-quality monitoring data, along with data on ecotoxicological and toxicological effects, are needed for the risk assessments                              that support the selection of new priority substances. The monitoring data collected from Member States, although significantly                              improved over the past years, are not always fit for purpose in terms of quality and Union coverage. Monitoring data are particularly                              lacking for many emerging pollutants, which can be defined as pollutants currently not included in routine monitoring programmes                              at Union level but which could pose a significant risk requiring regulation, depending upon their potential ecotoxicological                              and toxicological effects and on their levels in the aquatic environment.

(27)A new mechanism is needed to provide the Commission with targeted high-quality monitoring information on the concentration                              of substances in the aquatic environment, with a focus on emerging pollutants and substances for which available monitoring                              data are of insufficient quality for the purpose of risk assessment. The new mechanism should facilitate the gathering of                              that information across Union river basins and complement monitoring data from programmes under Articles 5 and 8 of Directive                              2000/60/EC and other reliable sources. In order to maintain monitoring costs at reasonable levels, the mechanism should focus                              on a limited number of substances, included temporarily in a watch list, and a limited number of monitoring sites, but should                              provide representative data that are fit for the purpose of the Union prioritisation process. The list should be dynamic and                              its validity in time should be limited, in order to respond to new information on the potential risks posed by emerging pollutants                              and to avoid monitoring substances for longer than necessary.

(28)In order to simplify and streamline reporting obligations for the Member States, and increase coherence with other related                              aspects of water management, the notification requirements in Article 3 of Directive 2008/105/EC should be merged with the                              overall reporting obligations under Article 15 of Directive 2000/60/EC.

(29)As regards the presentation of chemical status in accordance with Section 1.4.3 of Annex V to Directive 2000/60/EC, for the                              purposes of the update of the programmes of measures and of the river basin management plans to be carried out in accordance                              with Article 11(8) and Article 13(7) of Directive 2000/60/EC respectively, Member States should be allowed to present separately                              the impact on chemical status of newly identified priority substances and of existing priority substances with revised EQS,                              so that the introduction of new requirements is not mistakenly perceived as an indication that the chemical status of surface                              waters has deteriorated. In addition to the obligatory map covering all substances, additional maps, covering newly identified                              substances and existing substances with revised EQS, and separately covering the rest of the substances, could be provided.

(30)It is important that environmental information on the status of Union surface waters and on the achievements of strategies                              against chemical pollution is made available to the public in a timely manner. With a view to strengthening access and transparency,                              a central portal providing information on the river basin management plans and their reviews and updates should be accessible                              to the public electronically in each Member State.

(31)With the adoption of this proposal and submission of its report to the European Parliament and to the Council, the Commission                              has completed its first review of the list of priority substances as required under Article 8 of Directive 2008/105/EC. This                              has included a review of the substances listed in Annex III to that Directive, some of which have been identified for prioritisation.                              There is currently insufficient evidence to prioritise the other substances listed in Annex III. The possibility of new information                              regarding those substances becoming available means that they are not excluded from future review, as is the case for the                              other substances considered but not prioritised in the present review. Annex III to Directive 2008/105/EC has therefore become                              obsolete and should be deleted. Article 8 of that Directive should be amended accordingly, also regarding the date of reporting                              to the European Parliament and to the Council.

(32)In order to react to relevant technical and scientific progress in the area covered by this Directive in a timely manner,                              the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the updating                              of the methods for applying the EQS laid down in the Directive. It is of particular importance that the Commission carry out                              appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing                              up delegated acts, should ensure simultaneous, timely and appropriate transmission of relevant documents to the European Parliament                              and to the Council.

(33)In order to improve the information basis for future identification of priority substances, in particular as regards emerging                              pollutants, implementing powers should be conferred on the Commission in respect of the establishment and updating of a watch                              list. Furthermore, in order to ensure uniform conditions for the implementation of this Directive and for the formats for                              the reporting to the Commission of the monitoring data and information, implementing powers should be conferred on the Commission.                              Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council                              of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of                              the Commission’s exercise of implementing powers(15).

(34)In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory                              documents(16), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one                              or more documents explaining the relationship between the components of a directive and the corresponding parts of national                              transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be                              justified.

(35)Since the objective of this Directive, namely that of achieving good surface water chemical status by laying down EQS for                              priority substances and certain other pollutants, cannot be sufficiently achieved by the Member States and can therefore,                              by reason of the need to maintain the same level of protection of surface water throughout the Union, 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 Directive                              does not go beyond what is necessary in order to achieve that objective.

(36)Directives 2000/60/EC and 2008/105/EC should therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

# Article 1U.K.

Directive 2000/60/EC is amended as follows:

Article 16(4) is replaced by the following:

‘4.The Commission shall review the adopted list of priority substances at the latest four years after the date of entry into                                    force of this Directive and at least every six years thereafter, and come forward with proposals as appropriate.’;                           

Annex X is replaced by the text set out in Annex I to this Directive.

# Article 2U.K.

Directive 2008/105/EC is amended as follows:

Article 2 is replaced by the following:

## ‘Article 2Definitions

For the purposes of this Directive, the definitions laid down in Article 2 of Directive 2000/60/EC and in Article 2 of Commission                                 Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of the European Parliament and of the Council,                                 technical specifications for chemical analysis and monitoring of water status(17) shall apply.                           

In addition, the following definitions shall apply:                           

“matrix” means a compartment of the aquatic environment, namely water, sediment or biota;                                    

“biota taxon” means a particular aquatic taxon within the taxonomic rank “sub-phylum”, “class” or their equivalent.’;                                    

Article 3 is replaced by the following:

## ‘Article 3Environmental quality standards

1.Without prejudice to paragraph 1a, Member States shall apply the EQS laid down in Part A of Annex I for bodies of surface                                    water, and shall apply those EQS in accordance with the requirements laid down in Part B of Annex I.                           

1a.Without prejudice to the obligations arising under this Directive in the version in force on 13 January 2009 and in particular                                    the achievement of good surface water chemical status in relation to the substances and the EQS listed therein, Member States                                    shall implement the EQS laid down in Part A of Annex I as regards:                           

the substances numbered 2, 5, 15, 20, 22, 23, 28 in Part A of Annex I, for which revised EQS are set, with effect from 22                                          December 2015, with the aim of achieving good surface water chemical status in relation to those substances by 22 December                                          2021 by means of programmes of measures included in the 2015 river basin management plans produced in accordance with Article                                          13(7) of Directive 2000/60/EC; and                                    

the newly identified substances numbered 34 to 45 in Part A of Annex I, with effect from 22 December 2018, with the aim of                                          achieving good surface water chemical status in relation to those substances by 22 December 2027 and preventing deterioration                                          in the chemical status of surface water bodies in relation to those substances. For this purpose, Member States shall, by                                          22 December 2018, establish and submit to the Commission a supplementary monitoring programme and a preliminary programme                                          of measures covering those substances. A final programme of measures in accordance with Article 11 of Directive 2000/60/EC                                          shall be established by 22 December 2021 and shall be implemented and made fully operational as soon as possible after that                                          date and not later than 22 December 2024.                                    

Article 4(4) to (9) of Directive 2000/60/EC shall apply *mutatis mutandis* to the substances listed in points (i) and (ii) of the first subparagraph.                           

2.For the substances numbered 5, 15, 16, 17, 21, 28, 34, 35, 37, 43 and 44 in Part A of Annex I, Member States shall apply the                                    biota EQS laid down in Part A of Annex I.                           

For substances other than those referred to in the first subparagraph, Member States shall apply the water EQS laid down in                                 Part A of Annex I.                           

3.Member States may opt, in relation to one or more categories of surface water, to apply an EQS for a matrix other than that                                    specified in paragraph 2, or, where relevant, for a biota taxon other than those specified in Part A of Annex I.                           

Member States that make use of the option referred to in the first subparagraph shall apply the relevant EQS laid down in                                 Part A of Annex I or, if none is included for the matrix or biota taxon, establish an EQS that offers at least the same level                                 of protection as the EQS laid down in Part A of Annex I.                           

Member States may use the option referred to in the first subparagraph only where the method of analysis used for the chosen                                 matrix or biota taxon fulfils the minimum performance criteria laid down in Article 4 of Directive 2009/90/EC. Where those                                 criteria are not met for any matrix, Member States shall ensure that monitoring is carried out using best available techniques                                 not entailing excessive costs and that the method of analysis performs at least as well as that available for the matrix specified                                 in paragraph 2 of this Article for the relevant substance.                           

3a.Where a potential risk to, or via, the aquatic environment from acute exposure has been identified as a result of measured                                    or estimated environmental concentrations or emissions and where a biota or sediment EQS is being applied, Member States shall                                    ensure that monitoring in surface water is also carried out and shall apply the MAC-EQS laid down in Part A of Annex I to                                    this Directive where such EQS have been established.                           

3b.Where, pursuant to Article 5 of Directive 2009/90/EC, the calculated mean value of a measurement, when carried out using the                                    best available technique not entailing excessive costs, is referred to as “less than limit of quantification”, and the limit                                    of quantification of that technique is above the EQS, the result for the substance being measured shall not be considered                                    for the purposes of assessing the overall chemical status of that water body.                           

4.For substances for which an EQS for sediment and/or biota is applied, Member States shall monitor the substance in the relevant                                    matrix at least once every year, unless technical knowledge and expert judgment justify another interval.                           

5.Member States shall include the following information in the updated river basin management plans produced in accordance with                                    Article 13(7) of Directive 2000/60/EC:                           

(a)a table presenting the limits of quantification of the methods of analysis applied, and information on the performance of                                    those methods in relation to the minimum performance criteria laid down in Article 4 of Directive 2009/90/EC;                           

(b)for the substances for which the option in paragraph 3 of this Article is used:                           

the reasons and basis for using that option;                                    

where relevant, the alternative EQS established, evidence that those EQS would offer at least the same level of protection                                          as the EQS laid down in Part A of Annex I, including the data and methodology used to derive the EQS, and the categories of                                          surface water to which they would apply;                                    

for comparison with the information referred to in point (a) of this paragraph, the limits of quantification of the methods                                          of analysis for the matrices specified in Part A of Annex I to this Directive, including information on the performance of                                          those methods in relation to the minimum performance criteria laid down in Article 4 of Directive 2009/90/EC;                                    

(c)justification for the frequency of monitoring applied in accordance with paragraph 4, if monitoring intervals are longer than                                    one year.                           

5a.Member States shall take the necessary measures to ensure that the updated river basin management plans, produced in accordance                                    with Article 13(7) of Directive 2000/60/EC, containing the results and impact of the measures taken to prevent chemical pollution                                    of surface water, and the interim report describing progress in the implementation of the planned programme of measures in                                    accordance with Article 15(3) of Directive 2000/60/EC, are provided through a central portal which is accessible to the public                                    electronically in accordance with Article 7(1) of Directive 2003/4/EC of the European Parliament and of the Council of 28                                    January 2003 on public access to environmental information(18).                           

6.Member States shall arrange for the long-term trend analysis of concentrations of those priority substances listed in Part                                    A of Annex I that tend to accumulate in sediment and/or biota, giving particular consideration to the substances numbered                                    2, 5, 6, 7, 12, 15, 16, 17, 18, 20, 21, 26, 28, 30, 34, 35, 36, 37, 43 and 44 listed in Part A of Annex I, on the basis of                                    the monitoring of surface water status carried out in accordance with Article 8 of Directive 2000/60/EC. Member States shall                                    take measures aimed at ensuring, subject to Article 4 of Directive 2000/60/EC, that such concentrations do not significantly                                    increase in sediment and/or relevant biota.                           

Member States shall determine the frequency of monitoring in sediment and/or biota so as to provide sufficient data for a                                 reliable long-term trend analysis. As a guideline, monitoring should take place every three years, unless technical knowledge                                 and expert judgment justify another interval.                           

7.The Commission shall examine technical and scientific progress, including the conclusions of risk assessments as referred                                    to in points (a) and (b) of Article 16(2) of Directive 2000/60/EC and information from the registration of substances made                                    publicly available in accordance with Article 119 of Regulation (EC) No 1907/2006, and, if necessary, propose that the EQS                                    laid down in Part A of Annex I to this Directive be revised in accordance with the procedure laid down in Article 294 TFEU                                    in line with the timetable provided for in Article 16(4) of Directive 2000/60/EC.                           

8.The Commission shall be empowered to adopt delegated acts in accordance with Article 10, where necessary in order to adapt                                    point 3 of Part B of Annex I to this Directive to scientific or technical developments.                           

8a.In order to facilitate the implementation of this Article, technical guidelines on monitoring strategies and analytical methods                                    for substances, including sampling and monitoring of biota, shall be developed, to the extent possible, by 22 December 2014,                                    as part of the existing implementation process of Directive 2000/60/EC.                           

In particular, the guidelines shall cover:                           

(a)the monitoring of substances in biota as provided for in paragraphs 2 and 3 of this Article;                           

(b)in the case of newly identified substances (numbered 34 to 45 in Part A of Annex I) and substances for which stricter EQS                                    are established (numbered 2, 5, 15, 20, 22, 23 and 28 in Part A of Annex I), analytical methods compliant with the minimum                                    performance criteria laid down in Article 4 of Directive 2009/90/EC.                           

8b.In the case of substances for which technical guidelines have not been adopted by 22 December 2014, the deadline of 22 December                                    2015 referred to in point (i) of paragraph (1a) shall be extended to 22 December 2018, and the deadline of 22 December 2021                                    referred to in that point shall be extended to 22 December 2027.’;                           

Article 4(4) and Article 5(6) are deleted;

the following Article is inserted:

## ‘Article 7aCoordination

1.For priority substances that fall within the scope of Regulations (EC) No 1907/2006, (EC) No 1107/2009(19), (EU) No 528/2012(20) or Directive 2010/75/EU(21), the Commission shall, as part of the regular review of Annex X to Directive 2000/60/EC pursuant to Article 16(4) of that                                    Directive, assess whether the measures in place at Union and Member State level are sufficient to achieve the EQS for priority                                    substances and the cessation or phasing-out objective for discharges, emissions and losses of priority hazardous substances                                    in accordance with point (a) of Article 4(1) and Article 16(6) of Directive 2000/60/EC.                           

2.The Commission shall report to the European Parliament and to the Council on the outcome of the assessment referred to in                                    paragraph 1 of this Article in accordance with the timetable laid down in Article 16(4) of Directive 2000/60/EC and shall                                    accompany its report with any appropriate proposals including for control measures.                           

3.Where the results of the report show that additional measures at Union or Member State level may be necessary in order to                                    facilitate compliance with Directive 2000/60/EC in relation to a particular substance approved pursuant to Regulation (EC)                                    No 1107/2009 or Regulation (EU) No 528/2012, Member States or the Commission shall apply Articles 21 or 44 of Regulation (EC)                                    No 1107/2009 or Articles 15 or 48 of Regulation (EU) No 528/2012, as appropriate, to that substance, or products containing                                    that substance.                           

In the case of substances falling within the scope of Regulation (EC) No 1907/2006, the Commission shall initiate, where appropriate,                                 the procedure referred to in Articles 59, 61 or 69 of that Regulation.                           

In applying the provisions of the Regulations referred to in the first and second subparagraphs, Member States and the Commission                                 shall take into account any risk evaluations and socio-economic or cost-benefit analyses required under those Regulations,                                 including as regards the availability of alternatives.’;                           

Articles 8 and 9 are replaced by the following:

## ‘Article 8Review of Annex X to Directive 2000/60/EC

The Commission shall report to the European Parliament and to the Council on the outcome of the regular review of Annex X                                 to Directive 2000/60/EC provided for in Article 16(4) of that Directive. It shall accompany the report, where appropriate,                                 with legislative proposals to amend Annex X including, in particular, proposals to identify new priority substances or priority                                 hazardous substances or to identify certain priority substances as priority hazardous substances and to set corresponding                                 EQS for surface water, sediment or biota, as appropriate.                           

## Article 8aSpecific provisions for certain substances

1.In the river basin management plans produced in accordance with Article 13 of Directive 2000/60/EC, without prejudice to the                                    requirements of Section 1.4.3 of Annex V thereof regarding the presentation of the overall chemical status and the objectives                                    and obligations laid down in point (a) of Article 4(1), in point (k) of Article 11(3) and in Article 16(6) of that Directive,                                    Member States may provide additional maps that present the chemical status information for one or more of the following substances                                    separately from the information for the rest of the substances identified in Part A of Annex I to this Directive:                           

(a)substances numbered 5, 21, 28, 30, 35, 37, 43 and 44 (substances behaving like ubiquitous PBTs);                           

(b)substances numbered 34 to 45 (newly identified substances);                           

(c)substances numbered 2, 5, 15, 20, 22, 23 and 28 (substances for which revised, stricter EQS are established).                           

Member States may also present the extent of any deviation from the EQS value for the substances referred to in points (a)                                 to (c) of the first subparagraph in the river basin management plans. Member States providing such additional maps shall seek                                 to ensure their inter-comparability at river basin and Union level.                           

2.Member States may monitor the substances numbered 5, 21, 28, 30, 35, 37, 43 and 44 in Part A of Annex I less intensively than                                    is required for priority substances in accordance with Article 3(4) of this Directive and Annex V to Directive 2000/60/EC,                                    provided that the monitoring is representative and a statistically robust baseline is available regarding the presence of                                    those substances in the aquatic environment. As a guideline, in accordance with the second subparagraph of Article 3(6) of                                    this Directive, monitoring should take place every three years, unless technical knowledge and expert judgment justify another                                    interval.                           

## Article 8bWatch list

1.The Commission shall establish a watch list of substances for which Union-wide monitoring data are to be gathered for the                                    purpose of supporting future prioritisation exercises in accordance with Article 16(2) of Directive 2000/60/EC, to complement                                    data from, inter alia, analyses and reviews under Article 5 and monitoring programmes under Article 8 of that Directive.                           

The first watch list shall contain a maximum of 10 substances or groups of substances and shall indicate the monitoring matrices                                 and the possible methods of analysis not entailing excessive costs for each substance. Subject to the availability of methods                                 of analysis not entailing excessive costs, the maximum number of substances or groups of substances that the Commission is                                 allowed to include in the list shall increase by one at each update of the list in accordance with paragraph 2 of this Article,                                 up to a maximum number of 14. The substances to be included in the watch list shall be selected from amongst those for which                                 the information available indicates that they may pose a significant risk at Union level to, or via, the aquatic environment                                 and for which monitoring data are insufficient.                           

Diclofenac (CAS 15307-79-6), 17-beta-estradiol (E2) (CAS 50-28-2) and 17-alpha-ethinylestradiol (EE2) (CAS 57-63-6) shall                                 be included in the first watch list, in order to gather monitoring data for the purpose of facilitating the determination                                 of appropriate measures to address the risk posed by those substances.                           

In selecting the substances for the watch list, the Commission shall take into account all available information including:                           

(a)the results of the most recent regular review of Annex X to Directive 2000/60/EC provided for in Article 16(4) of that Directive;                           

(b)research projects;                           

(c)recommendations from the stakeholders referred to in Article 16(5) of Directive 2000/60/EC;                           

(d)Member States’ characterisation of river basin districts and the results of monitoring programmes, under Articles 5 and 8                                    of Directive 2000/60/EC respectively;                           

(e)on production volumes, use patterns, intrinsic properties (including, where relevant, particle size), concentrations in the                                    environment and effects, including information gathered in accordance with Directives 98/8/EC, 2001/82/EC(22) and 2001/83/EC(23), and with Regulations (EC) No 1907/2006 and (EC) No 1107/2009.                           

2.The Commission shall establish the first watch list as referred to in paragraph 1 by 14 September 2014 and shall update it                                    every 24 months thereafter. When updating the watch list, the Commission shall remove any substance for which a risk-based                                    assessment as referred to in Article 16(2) of Directive 2000/60/EC can be concluded without additional monitoring data. The                                    duration of a continuous watch list monitoring period for any individual substance shall not exceed four years.                           

3.Member States shall monitor each substance in the watch list at selected representative monitoring stations over at least                                    a 12-month period. For the first watch list, the monitoring period shall commence by 14 September 2015 or within six months                                    of the establishment of the watch list, whichever is the later. For each substance included in subsequent lists, Member States                                    shall commence monitoring within six months of its inclusion in the list.                           

Each Member State shall select at least one monitoring station, plus one station if it has more than one million inhabitants,                                 plus the number of stations equal to its geographical area in km2 divided by 60 000 (rounded to the nearest integer), plus the number of stations equal to its population divided by five million(rounded                                 to the nearest integer).                           

In selecting the representative monitoring stations, the monitoring frequency and timing for each substance, Member States                                 shall take into account the use patterns and possible occurrence of the substance. The frequency of monitoring shall be no                                 less than once per year.                           

Where a Member State provides sufficient, comparable, representative and recent monitoring data for a particular substance                                 from existing monitoring programmes or studies, it may decide not to undertake additional monitoring under the watch list                                 mechanism for that substance, provided also that the substance was monitored using a methodology that satisfies the requirements                                 of the technical guidelines developed by the Commission in accordance with Article 8b(5).                           

4.Member States shall report to the Commission the results of the monitoring carried out pursuant to paragraph 3. For the first                                    watch list, the monitoring results shall be reported within 15 months of 14 September 2015 or within 21 months of the establishment                                    of the watch list, whichever is the later, and every 12 months thereafter while the substance is kept on the list. For each                                    substance included in subsequent lists, Member States shall report the results of the monitoring to the Commission within                                    21 months of the inclusion of the substance in the watch list, and every 12 months thereafter while the substance is kept                                    on the list. The report shall include information on the representativeness of the monitoring stations and monitoring strategy.                           

5.The Commission shall adopt implementing acts establishing and updating the watch list as referred to in paragraphs 1 and 2.                                    It may also adopt technical formats for reporting the monitoring results and related information to the Commission. Those                                    implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2).                           

The Commission shall develop guidelines, including technical specifications, with a view to facilitating the monitoring of                                 the substances in the watch list and is invited to promote coordination of such monitoring.                           

## Article 8cSpecific provisions for pharmaceutical substances

Pursuant to Article 16(9) of Directive 2000/60/EC, and where appropriate on the basis of the outcome of its 2013 study on                                 the risks posed by medicinal products in the environment and of other relevant studies and reports, the Commission shall,                                 as far as possible within two years from 13 September 2013 develop a strategic approach to pollution of water by pharmaceutical                                 substances. That strategic approach shall, where appropriate, include proposals enabling, to the extent necessary, the environmental                                 impacts of medicines to be taken into account more effectively in the procedure for placing medicinal products on the market.                                 In the framework of that strategic approach, the Commission shall, where appropriate, by 14 September 2017 propose measures                                 to be taken at Union and/or Member State level, as appropriate, to address the possible environmental impacts of pharmaceutical                                 substances, particularly those referred to in Article 8b(1), with a view to reducing discharges, emissions and losses of such                                 substances into the aquatic environment, taking into account public health needs and the cost-effectiveness of the measures                                 proposed.                           

## Article 9Committee procedure

1.The Commission shall be assisted by the Committee established under Article 21(1) of Directive 2000/60/EC. That Committee                                    is a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February                                    2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise                                    of implementing powers(24).                           

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 9aExercise 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 3(8) shall be conferred on the Commission for a period of six years                                    from 13 September 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months                                    before the end of the six-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 3(8) 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.As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the                                    Council.                           

5.A delegated act adopted pursuant to Article 3(8) 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.’;                           

Annex I is amended as follows:

Part A is replaced by the text set out in Annex II to this Directive;

points 2 and 3 of Part B are replaced by the following:

## ‘2.Columns 6 and 7 of the table: for any given surface water body, applying the MAC-EQS means that the measured concentration                                             at any representative monitoring point within the water body does not exceed the standard.

However, in accordance with Section 1.3.4 of Annex V to Directive 2000/60/EC, Member States may introduce statistical methods,                                          such as a percentile calculation, to ensure an acceptable level of confidence and precision for determining compliance with                                          the MAC-EQS. Where Member States do so, such statistical methods shall comply with detailed rules laid down in accordance                                          with the examination procedure referred to in Article 9(2) of this Directive.                                    

## 3.The water EQS laid down in this Annex are expressed as total concentrations in the whole water sample.

By way of derogation from the first subparagraph, in the case of cadmium, lead, mercury and nickel (hereinafter “metals”),                                          the water EQS refer to the dissolved concentration, i.e. the dissolved phase of a water sample obtained by filtration through                                          a 0,45 μm filter or any equivalent pre-treatment, or, where specifically indicated, to the bioavailable concentration.                                    

Member States may, when assessing the monitoring results against the relevant EQS, take into account:                                    

natural background concentrations for metals and their compounds where such concentrations prevent compliance with the relevant                                                   EQS;                                             

hardness, pH, dissolved organic carbon or other water quality parameters that affect the bioavailability of metals, the bioavailable                                                   concentrations being determined using appropriate bioavailability modelling.’;                                             

Annexes II and III are deleted.

# Article 3U.K.

1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive                        by 14 September 2015. They shall forthwith communicate to the Commission the text of those provisions.                  

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference                     on the occasion of their official publication. Member States shall determine how such reference is to be made.                  

2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the                        field covered by this Directive.                  

# Article 4U.K.

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

# Article 5U.K.

This Directive is addressed to the Member States.

Done at Brussels, 12 August 2013.

*For the European Parliament*                            

*The President*                            

M. Schulz                            

*For the Council*                            

*The President*                            

L. Linkevičius                            

## ANNEX IU.K.

### “‘ANNEX X

#### **LIST OF PRIORITY SUBSTANCES IN THE FIELD OF WATER POLICY**

## ANNEX IIU.K.

### “‘ANNEX I**ENVIRONMENTAL QUALITY STANDARDS FOR PRIORITY SUBSTANCES AND CERTAIN OTHER POLLUTANTS**

### PART A:U.K.ENVIRONMENTAL QUALITY STANDARDS (EQS)

:

annual average.

:

maximum allowable concentration.

:

[μg/l] for columns (4) to (7)

[μg/kg wet weight] for column (8)

1

OJ C 229, 31.7.2012, p. 116.                           

2

OJ C 17, 19.1.2013, p. 91.                           

3

Position of the European Parliament of 2 July 2013 (not yet published in the Official Journal) and decision of the Council                              of 22 July 2013.                           

4

OJ L 327, 22.12.2000, p. 1.                           

5

OJ L 331, 15.12.2001, p. 1.                           

6

OJ L 348, 24.12.2008, p. 84.                           

7

OJ L 309, 24.11.2009, p. 1.                           

8

OJ L 396, 30.12.2006, p. 1.                           

9

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on                              the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).                           

10

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary                              medicinal products (OJ L 311, 28.11.2001, p. 1).                           

11

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal                              products for human use (OJ L 311, 28.11.2001, p. 67).                           

12

Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated                              pollution prevention and control) (OJ L 334, 17.12.2010, p. 17).                           

13

OJ L 84, 5.4.1993, p. 1.                           

14

OJ L 201, 1.8.2009, p. 36.                           

15

OJ L 55, 28.2.2011, p. 13.                           

16

OJ C 369, 17.12.2011, p. 14.                           

17

OJ L 201, 1.8.2009, p. 36.’;                           

18

OJ L 41, 14.2.2003, p. 26.’;                           

19

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant                              protection products on the market (OJ L 309, 24.11.2009, p. 1).                           

20

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on                              the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).                           

21

Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated                              pollution prevention and control) (OJ L 334, 17.12.2010, p. 17).’;                           

22

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary                              medicinal products (OJ L 311, 28.11.2001, p. 1).                           

23

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal                              products for human use (OJ L 311, 28.11.2001, p. 67).                           

24

OJ L 55, 28.2.2011, p. 13.’;