46 Amendments of Silvia SARDONE related to 2022/0344(COD)
Amendment 36 #
Proposal for a directive
Recital 1
Recital 1
(1) Chemical pollution of surface and groundwater 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, as well as to human health. Setting environmental quality standards may helps to implement the zero pollution ambition for a toxic-free environment, provided that they are accompanied by gradual and concerted mitigation measures.
Amendment 54 #
Proposal for a directive
Recital 7
Recital 7
(7) A combination of source-control and end-of-pipe measures is required to effectively deal with most pollutants across their life cycle, including, as relevant, chemical design, authorisation or approval, control of emissions during manufacturing and use or other processes, and waste handling. The setting of new or stricter quality standards in water bodies therefore complements and is coherent with other Union legislation that addresses or could address the pollution problem at one or more of those stages, including Regulation (EC) No 1907/2006 of the European Parliament and of the Council49,Regulation (EC) No 1107/2009 of the European Parliament and of the Council50, Regulation (EU) No 528/2012 of the European Parliament and of the Council51, Regulation (EU) 2019/6 of the European Parliament and of the Council52, Directive 2001/83/EC of the European Parliament and of the Council53, Directive 2009/128/EC of the European Parliament and of the Council54, Directive 2010/75/EU of the European Parliament and of the Council55and Council Directive 91/271/EEC56, and specific measures should be provided for end users, who are likely to shoulder the heaviest burden as a result of the application of the directive. _________________ 49 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 (OJ L 396, 30.12.2006, p. 1). 50 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 and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 51 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). 52 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43). 53 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). 54 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, p. 71). 55 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). 56 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).
Amendment 57 #
Proposal for a directive
Recital 8
Recital 8
(8) The new scientific knowledge points to a significant risk from several other pollutants found in water bodies, in addition to those already regulated. In groundwater, a particular problem has been identified through voluntary monitoring for per- and polyfluoroalkyl substances (PFAS) and pharmaceuticals. PFAS have been detected at more than 70% of the groundwater measuring points in the Union and existing national thresholds are clearly exceeded at a considerable number of locations, and pharmaceutical substances are also widely found. In surface waters, perfluorooctane sulfonic acid and its derivatives are already listed as priority substances, but other PFAS are now also recognised to pose a risk. Watch-list monitoring under Article 8b of Directive 2008/105/EC has confirmed a risk in surface waters from a number of pharmaceutical substances which should therefore be added to the priority substances list. These substances should be monitored whenever the risk assessment and the river basin risk management pertaining to the abstraction points, carried out in accordance with Article 8 of Directive (EU) 2020/2184, find that these substances are likely to be present in a specific water supply. Furthermore, the values should be applied only once technical guidelines for monitoring this parameter have been drawn up in accordance with Article 13(7) of Directive (EU) 2020/2184.
Amendment 69 #
Proposal for a directive
Recital 11
Recital 11
(11) Considering the growing awareness of the relevance of mixtures and therefore of effect-based monitoring for determining chemical status, and considering that sufficiently robust effect-based monitoring methods already exist for estrogenic substances, Member States should apply such methods to assess the cumulative effects of estrogenic substances in surface waters over a period of at least two years. This will allow the comparison of effect- based results with the results obtained using the conventional methods for monitoring the three estrogenic substances listed in Annex I to Directive 2008/105/EC. That comparison will be used to assess whether effect-based monitoring methods may be used as reliable screening methods. Using suchThe assessments will employ only screening methods wouldhich have the advantage ofproven within the scientific community to be very reliable at delivering accurate data. This would allowing the effects of all estrogenic substances having similar effects to be covered, and not only those listed in Annex I to Directive 2008/105/EC. The definition of EQS in Directive 2000/60/EC should be modified to ensure that it may, in the future, also cover trigger values that might be set for assessing the results of effect- based monitoring. In order for the screening methods to prove their high degree of reliability in the scientific community, the methods must be put forward for and subjected to a public notice and consultation in line with the existing procedure for proposing amendments to EU directives.
Amendment 80 #
Proposal for a directive
Recital 21
Recital 21
(21) To ensure effective and coherent decision-making and develop synergies with the work carried out in the framework of other Union legislation on chemicals, the European Chemicals Agency (‘ECHA’), should be given a permanent and clearly circumscribed role in the prioritisation of substances to be included in the watch lists and in the lists of substances in Annexes I and II to Directive 2008/105/EC and Annexes I and II to Directive 2006/118/EC, and in the derivation of appropriate science-based quality standards. The Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) of ECHA, should facilitate the carrying out of certain tasks conferred on ECHA by providing opinions. ECHA should also ensure better coordination between various pieces of environmental law through increased transparency as regards pollutants on a watch list or the development of Union wide or national EQS or thresholds, by making relevant scientific reports publicly available. To this end, the ECHA should determine the appropriate, proportionate and cost- effective level and combination of product and process checks for both point and diffuse sources. The substances should also be classified as priorities for action on the basis of the risk identified by means of a simplified assessment procedure anchored in scientific principles.
Amendment 98 #
Proposal for a directive
Recital 34 a (new)
Recital 34 a (new)
(34a) This directive introduces new and more demanding technical and technological services for both analytics and sampling. For these services to be sustainable, the Commission will carry out an in-depth economic feasibility assessment, in order to quantify the economic, bureaucratic and administrative costs that will fall to the authorities responsible for monitoring, and to examine other possibilities offering better procurement and alternatives for recruitment and staff training.
Amendment 99 #
Proposal for a directive
Recital 34 b (new)
Recital 34 b (new)
(34b) Given the cross-border nature of many river basins, an expert scientific study will be required to consider setting common EQS at the European level for river basin-specific pollutants.
Amendment 100 #
Proposal for a directive
Recital 34 c (new)
Recital 34 c (new)
Amendment 101 #
Proposal for a directive
Recital 34 d (new)
Recital 34 d (new)
(34d) Given the significance of the reference analytical methods and effect- based methods referred to in this directive, common reference guidelines will need to be issued in this regard.
Amendment 103 #
Proposal for a directive
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Directive 2000/60/EC
Article 1 – point e) – fourth indent
Article 1 – point e) – fourth indent
Amendment 105 #
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Directive 2000/60/EC
Article 2 – point 24)
Article 2 – point 24)
Amendment 106 #
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive 2000/60/EC
Article 2 – point 30)
Article 2 – point 30)
Amendment 116 #
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point c
Article 1 – paragraph 1 – point 2 – point c
Directive 2000/60/EC
Article 2 – point 30 a)
Article 2 – point 30 a)
Amendment 117 #
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point d
Article 1 – paragraph 1 – point 2 – point d
Amendment 129 #
Proposal for a directive
Article 1 – paragraph 1 – point 4 – point a
Article 1 – paragraph 1 – point 4 – point a
Directive 2000/60/EC
Article 4 – paragraph 1 – point a) – point iv)
Article 4 – paragraph 1 – point a) – point iv)
(iv) Member States shall implement the necessary measures to progressively reduce pollution from priority substances and river basin specific pollutants, and to cease or phase out emissions, discharges and losses of priority hazardous substances., with the exception of those no longer used or produced in Europe;
Amendment 137 #
Amendment 145 #
Proposal for a directive
Article 1 – paragraph 1 – point 7 – point a
Article 1 – paragraph 1 – point 7 – point a
Directive 2000/60/EC
Article 10 – paragraph 2 – point a)
Article 10 – paragraph 2 – point a)
(a) emission controls based on best available techniques;, to be established by the Commission in a specific delegated regulation
Amendment 166 #
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive 2000/60/EC
Article 20 a – paragraph 2
Article 20 a – paragraph 2
2. The power to adopt delegated acts referred to in Article 20(1) shall be conferred on the Commission for an indeterminate period of time from [OP please insert the date = the date of entry into force of this Directive]36 months following the issue of the reference guidelines on effect-based methods.
Amendment 168 #
Proposal for a directive
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Directive 2000/60/EC
Article 21 – paragraph 1
Article 21 – paragraph 1
1. The Commission shall be assisted by a committee. That committee on which the Member States shall be represented by experts in areas including the construction and management of flood defences and infrastructure, storage facilities and the use of water intended mainly for irrigation and environmental upkeep. It shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.
Amendment 171 #
Proposal for a directive
Article 1 – paragraph 1 – point 19
Article 1 – paragraph 1 – point 19
Directive 2000/60/EC
Annex VIII
Annex VIII
Amendment 178 #
Proposal for a directive
Article 2 – paragraph 1 – point 4 – point a Directive 2006/118/EC
Article 2 – paragraph 1 – point 4 – point a Directive 2006/118/EC
(c) threshold values established at Union level in accordance with Article 8(3) and listed in Part D of Annex II to this Directive.environmental quality standards set at European level for consistency among the Member States to prevent disparities in chemical classification;
Amendment 179 #
Proposal for a directive
Article 2 – paragraph 1 – point 4 – point b
Article 2 – paragraph 1 – point 4 – point b
Directive 2006/118/EC
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 180 #
Proposal for a directive
Article 2 – paragraph 1 – point 4 – point c
Article 2 – paragraph 1 – point 4 – point c
Directive 2006/118/EC
Article 3 – paragraph 5
Article 3 – paragraph 5
Amendment 181 #
Proposal for a directive
Article 2 – paragraph 1 – point 4 – point d
Article 2 – paragraph 1 – point 4 – point d
Directive 2006/118/EC
Article 3 – paragraph 6 – subparagraph 1
Article 3 – paragraph 6 – subparagraph 1
Amendment 184 #
Proposal for a directive
Article 2 – paragraph 1 – point 5
Article 2 – paragraph 1 – point 5
Directive 2006/118/EC
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
Amendment 186 #
Proposal for a directive
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 1 – subparagraph 1
Article 6a – paragraph 1 – subparagraph 1
The Commission is empowered to adopt implementing acts to establish, having regard to scientific reports prepared by ECHA, a watch list of substances for which Union-wide monitoring data are to be gathered by the Member States and to lay down the formats to be used by the Member States for reporting the results of that monitoring and related information to the Commission. The same analytical techniques and methods shall be set for all Member States for the sake of data comparability. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2).
Amendment 196 #
Proposal for a directive
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 1 – subparagraph 4
Article 6a – paragraph 1 – subparagraph 4
ECHA shall prepare scientific reports to assist the Commission in selecting the substances for the watch list, taking into account key scientific knowledge and the following information:
Amendment 210 #
Proposal for a directive
Article 2 – paragraph 1 – point 7
Article 2 – paragraph 1 – point 7
Directive 2006/118/EC
Article 8 – paragraph 1
Article 8 – paragraph 1
Amendment 219 #
Proposal for a directive
Article 2 – paragraph 1 – point 7
Article 2 – paragraph 1 – point 7
Directive 2006/118/EC
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The Commission is empowered to adopt delegated acts, in accordance with Article 8a, to amend Annex I to adapt it to technical and scientific progress by adding or removing groundwater pollutants and quality standards for those pollutants set out in that Annex and to amend Part B in orderPart B to adapt it to technical and scientific progress by adding pollutants or indicators for which Member States have to consider establishing national thresholds.
Amendment 235 #
Proposal for a directive
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
Directive 2006/118/EC
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The Commission shall be assisted by a Ccommittee. That committee on which the Member States shall be represented by experts in areas including the construction and management of flood defences and infrastructure, storage facilities and the use of water intended mainly for irrigation, for environmental upkeep. It shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.
Amendment 237 #
Proposal for a directive
Article 2 – paragraph 1 – point 11
Article 2 – paragraph 1 – point 11
Directive 2006/118/EC
Annex I
Annex I
Amendment 243 #
Proposal for a directive
Article 3 – paragraph 1 – point 2 – point a Directive 2008/105/EC
Article 3 – paragraph 1 – point 2 – point a Directive 2008/105/EC
(iii) the substances numbered 5, 9, 13, 15, 17, 21, 23, 24, 28, 30, 34, 37, 41, 44 in Part A of Annex I, for which revised EQS are set, and the newly identified substances numbered 46 to 70 in Part A of Annex I, with effect from … [OP please insert the date = the first day of the36 months following 18 months after the date of entry into force of this Directive]the issue of the guidelines on the reference analytical methods, with the aim of preventing deterioration in the chemical status of surface water bodies and of achieving good surface water chemical status in relation to those substances.;
Amendment 257 #
Proposal for a directive
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
Directive 2008/105/EC
Article 8 – paragraph 1
Article 8 – paragraph 1
1. The Commission shall review, for the first time by … [OP: Please insert the date = six years after the date of entry into force of this Directive] and every six years thereafter, the list of priority substances and the corresponding EQS for those substances set out in Part A of Annex I and the list of pollutants set out in Part A of Annex II. To this end, the Commission should determine the appropriate, proportionate and cost-effective level and combination of product and process checks for both point and diffuse sources. The substances should also be classified as priorities for action on the basis of the risk identified by means of a simplified assessment procedure anchored in scientific principles.
Amendment 275 #
Proposal for a directive
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
Directive 2008/105/EC
Article 8a – paragraph 3
Article 8a – paragraph 3
3. Member States shall, from … [OP please insert the date = the first day of the36 months following 18 months after the date of entry into force of this Directive], for a period of two yearthe issue of the guidelines on the reference analytical methods, monitor the presence of estrogenic substances in water bodies, using effect-based monitoring methods. They shall conduct the monitoring at least four times during each of the two years at locations where the three estrogenic hormones 7-Beta estradiol (E2), Estrone (E1) and Alpha-Ethinyl estradiol (EE2) listed in Part A to Annex I to this Directive, are being monitored using conventional analytical methods in accordance with Article 8 of Directive 2000/60/EC and Annex V to that Directive. Member States may use the network of monitoring sites identified for the surveillance monitoring of representative surface water bodies in accordance with point 1.3.1 of Annex V to Directive 2000/60/EC. To this end, the resources required to perform these activities need to be duly incorporated, and specific guidelines and reference analytical methods are essential. In addition, a training period should be factored in for staff at the national environmental agencies.
Amendment 276 #
Proposal for a directive
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 1
Article 8b – paragraph 1 – subparagraph 1
The Commission is empowered to adopt implementing acts to establish, having regard to scientific reports prepared by ECHA, a watch list of substances for which it is necessary to gather Union wide monitoring data from the Member States and to lay down the formats to be used by the Member States for reporting the results of that monitoring and related information to the Commission. The monitoring activities are not expected to entail costs for farms. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2).
Amendment 277 #
Proposal for a directive
Article 3 – paragraph 1 – point 7 Directive 2008/105/EC
Article 3 – paragraph 1 – point 7 Directive 2008/105/EC
The watch list shall contain a maximum of 10 substances or groups of substances at any one time, and shall indicate the monitoring matrices and the possible methods of analysis for each substance. Those monitoring matrices and methods shall not entail excessive costs for the competent authorities. For these investigations, an in-depth assessment will nevertheless be required to estimate the costs associated with monitoring, the analytical methods, equipment upgrades and dedicated staff. The substances to be included in the watch list shall be selected from amongst the substances 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. The watch list shall include substances of emerging concern.
Amendment 285 #
Proposal for a directive
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 3
Article 8b – paragraph 1 – subparagraph 3
As soon as suitable monitoring, precise and EU-wide analytical methods for monitoring micro- plastics (including the types that will need to be sought) and selected antimicrobial resistance genes have been identified, those substances shall be included in the watch list.
Amendment 288 #
Proposal for a directive
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 4 – introductory part
Article 8b – paragraph 1 – subparagraph 4 – introductory part
ECHA shall prepare scientific reports to assist the Commission in selecting the substances for the watch list, taking into account key scientific knowledge and the following information:
Amendment 290 #
Proposal for a directive
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 4 – point e
Article 8b – paragraph 1 – subparagraph 4 – point e
(e) research projects and scientific publications, including information on trends and predictions based on modelling or other predictive assessments and data and information from remote sensing technologies, earth observation (Copernicus services), in-situ sensors and devices, or citizen science data, leveraging the opportunities offeprovided that the models or other predictive assessments, sensors and devices ared by artificial intelligence, advanced data analysis and processingroadly accepted by the scientific community as approaches with sound scientific foundations.
Amendment 297 #
Proposal for a directive
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
Directive 2008/105/EC
Article 8d
Article 8d
Amendment 299 #
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [OP please insert the date = the first day of the month following 18 months aftermonth once 36 months have elapsed since the datissue of entry into forcethe guidelines ofn this Directivee reference analytical methods].
Amendment 306 #
Proposal for a directive
Annex II – paragraph 1 – point 2
Annex II – paragraph 1 – point 2
Directive 2000/60/EC
Annex VIII – point 13
Annex VIII – point 13
Amendment 310 #
Proposal for a directive
Annex III
Annex III
Directive 2006/118/EC
Annex I – Footnote 12 a (new)
Annex I – Footnote 12 a (new)
(12a) All references to the PFAS shall include their salts and the linear and branched structural isomers.
Amendment 311 #
Proposal for a directive
Annex III
Annex III
Directive 2006/118/EC
Annex I – Footnote 12 b (new)
Annex I – Footnote 12 b (new)
(12b) Given the different criteria for identifying metabolites in the Member States, provision will need to be made, before this directive enters into force, for a list of active substances together with the relevant and non-relevant metabolites and information on the associated risk.
Amendment 316 #
Proposal for a directive
Annex V – paragraph 1 – point 2
Annex V – paragraph 1 – point 2
Directive 2008/105/EC
Annex I Part A – Table – Row 2 – Footnote 3
Annex I Part A – Table – Row 2 – Footnote 3
(3) This parameter is the EQS expressed as an annual average value (AA‑- EQS). Unless otherwise specified, it applies to the total concentration of all substances anisomers, including branched isomers.
Amendment 317 #
Proposal for a directive
Annex V – paragraph 1 – point 2
Annex V – paragraph 1 – point 2
Directive 2008/105/EC
Annex I – Part A – Table – Row 9 – Footnote 10
Annex I – Part A – Table – Row 9 – Footnote 10
(10) No indicative parameter is provided for this group of substances. The indicative parameter(s) must be dey therefore need to be clearly identifined through the analytical methodand standardised at Member State level.