Article 1
Directive 2000/60/EC is amended as follows: Article 16(4) is replaced...
Article 2
Directive 2008/105/EC is amended as follows: Article 2 is replaced...
Article 3
(1) Member States shall bring into force the laws, regulations...
Article 4
This Directive shall enter into force on the twentieth day...
Article 5
This Directive is addressed to the Member States.
ANNEX I
‘ANNEX X LIST OF PRIORITY SUBSTANCES IN THE FIELD OF...
ANNEX II
‘ANNEX I ENVIRONMENTAL QUALITY STANDARDS FOR PRIORITY SUBSTANCES AND CERTAIN...
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 ,
Having regard to the opinion of the Committee of the Regions ,
Acting in accordance with the ordinary legislative procedure ,
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 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 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 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 .
(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 , 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 or Directives 2001/82/EC , 2001/83/EC or 2010/75/EU . 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 , 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 , 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 .
(34)
In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents , 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:
OJ C 229, 31.7.2012, p. 116.
OJ C 17, 19.1.2013, p. 91.
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.
OJ L 327, 22.12.2000, p. 1.
OJ L 331, 15.12.2001, p. 1.
OJ L 348, 24.12.2008, p. 84.
OJ L 309, 24.11.2009, p. 1.
OJ L 396, 30.12.2006, p. 1.
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).
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).
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).
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).
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OJ L 201, 1.8.2009, p. 36.
OJ L 55, 28.2.2011, p. 13.
OJ C 369, 17.12.2011, p. 14.