Changes from adopted text to adopted text

Removed*** 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 (OJ L 396, 30.12.2006, p. 1).

Removed**** 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).

Removed***** 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).

Removed****** Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (OJ L 4, 7.1.2019, p. 43).

Removed******* 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).

Removed******** 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). ’

Removed(6a) The following Article is inserted:

Removed‘Article 6aa Improving protection of groundwater ecosystems

RemovedThe Commission shall, not later than [OP: please insert the date = four years after the date of entry into force of this Directive], publish an assessment of the impacts of physico-chemical elements, like pH, oxygenation, and temperature, on health of groundwater ecosystems, accompanied, where appropriate, by a legislative proposal to revise this Directive accordingly, in order to set the corresponding parameters, provide for harmonized monitoring methods, and define what would constitute a “good ecological status” for groundwater.'’ [Am. 92]

Removed(6b) The following Article is inserted:

Removed‘Article 6ab Specific treatment for areas of high ecological value, vulnerability or pollution

RemovedThe Commission shall,... [not later than four years after the entry into force of this Directive], publish an assessment of the chemical status of areas characterised by high ecological value, vulnerability or pollution, such as caves and karst areas, former industrial sites and other areas with known historical contamination, accompanied, where appropriate, by a legislative proposal to revise this Directive.’ [Am. 93]

Removed(6c) The following Article is inserted:

Removed‘Article 6ac

RemovedNo later than... [one year after the date of entry into force of this Directive], the Commission shall present an impact assessment examining the inclusion in this Directive of an extended producer responsibility mechanism, ensuring that producers that place on the market products containing any of the substances or compounds listed in Annex I, as well as substances of emerging concern included in the watch list under this Directive, contribute to the costs for monitoring programmes designed under Article 8 of Directive 2000/60/EC. The impact assessment shall be accompanied, where appropriate, by a legislative proposal to revise this Directive.’ [Am. 94]

Removed(6d) The following Article is inserted:

Removed‘Article 6ad European monitoring facility

RemovedThe Commission shall by... [one year after the date of entry into force of this Directive], set up a joint monitoring facility for managing the monitoring requirements when so requested by the Member States.

RemovedThe Commission shall define the functioning of the monitoring facility, which shall cover, inter alia, the following:

Removed(a) the voluntary nature of the use of the monitoring facility, which shall be without prejudice to arrangements already put in place by the Member States;

Removed(b) the operational procedures for Member States that intend to make use of the monitoring facility, which shall, inter alia, include the required notification to the Commission of their exact monitoring needs or capabilities, the exact protocols for samples managing, as well as the length of time they intend to remain part of the mechanism;

Removed(c) the sources of funding, which may include relevant Union structural funds and programmes, as well as contributions from the private sector, including under the extended producer responsibility mechanism, once put in place in accordance with Article 6ac.’ [Am. 95]

Removed(7) Article 8 is replaced by the following:

Removed‘Article 8

RemovedReview of Annexes I to IV

Removed1. The Commission shall review, for the first time by … [OP: please insert the date = six four years after the date of entry into force of this Directive] and every sixfour years thereafter, the list of pollutants set out in Annex I and the quality standards for those pollutants set out in that Annex, as well as the list of pollutants and indicators set out in Part B of Annex II. [Am. 96]

Removed2. Based on the review, the Commission is empowered to adopt delegated acts, in accordance with Article 8a,shall, where appropriate, come forward with legislative proposals 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. The Commission is empowered to adopt delegated acts, in accordance with Article 8a, and to amend Part B of Annex II in order to adapt it to technical and scientific progress by adding pollutants or indicators for which Member States have to consider establishing national thresholds. [Am. 97]

Removed3. The Commission is empowered to adopt delegated acts, in accordance with Article 8a, to amend Part D of Annex II in order to adapt it to scientific and technical progress by adding or amending harmonised threshold values for one or more pollutants listed in Part B of that Annex.

Removed4. When adopting legislative proposals and delegated acts as referred to in paragraphs 2 and 3, the Commission shall take the scientific reports prepared by ECHA pursuant to paragraph 6 of this Article into account. [Am. 98]

Removed5. The Commission is empowered to adopt delegated acts in accordance with Article 8a to amend Parts A and C of Annex II and Annexes III and IV in order to adapt them to scientific and technical progress.

Removed6. For the purpose of assisting the Commission with regard to the review of Annexes I and II, ECHA shall prepare scientific reports. Those reports shall take account of the following:

Removed(a) the opinion of the Committee for Risk Assessment and the Committee for Socio-Economic Analysis of ECHA;

Removed(b) the results of the monitoring programmes established in accordance with Article 8 of Directive 2000/60/EC;

Removed(c) the monitoring data collected in accordance with Article 6a(4) of this Directive;

Removed(d) the outcome of the reviews of the Annexes to Directive 2008/105/EC and Directive (EU) 2020/2184;

Removed(e) information and requirements to address soil pollution;

Removed(f) Union research programmes and scientific publications, including up-to-date information resulting from remote sensing technologies, earth observation (Copernicus services), in-situ sensors and devices and/or citizen science data, leveraging the opportunities offered by best available techniques which could include artificial intelligence, advanced data analysis and processing; [Am. 99]

Removed(g) comments and information from relevant stakeholders, including national regulatory authorities and other relevant bodies. [Am. 100]

Removed6a. By 12 January 2025, the Commission shall establish technical guidelines regarding methods of analysis for monitoring of per- and polyfluoroalkyl substances under the parameters ‘PFAS Total’. The Commission is empowered to adopt delegated acts in accordance with Article 8a amending this Directive by setting a quality standard for 'PFAS total' and amend Annex I accordingly. The Commission shall adopt these delegated acts by 12 January 2026. [Am. 101]

Removed7. ECHA shall, every sixfour years, prepare and make publicly available a report, summarizing the findings of the review referred to in paragraphs 2 and 3. The first report shall be submitted to the Commission on … [OP: Please insert the date = fivethree years after the date of entry into force of this Directive].’ [Am. 102]

Removed(8) the following Article 8a is inserted:

Removed’Article 8a

RemovedExercise of the delegation

Removed1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

Removed2. The power to adopt delegated acts referred to in Article 8(1) and (2)8(2), (3) and (6a) shall be conferred on the Commission for an indeterminatea period of time6 years from [OP please insert the date = the date of entry into force of this Directive]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the 6 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. [Am. 103]

Removed3. The delegation of power referred to in Article 8(1) and (2)8(2), (3) and (6a) may be revoked at any time by the European Parliament and 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 the delegated acts already in force. [Am. 104]

Removed4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-MarkingLaw-Making. [Am. 105]

Removed5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

Removed6. A delegated act adopted pursuant to Article 8(1) or (2)8(2), (3) or (6a) shall enter into force only if no objection has been expressed either by the European Parliament or by 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.;’ [Am. 106]

Removed(9) Article 9 is replaced by the following:

Removed‘Article 9

RemovedCommittee procedure

Removed1. The Commission shall be assisted by a Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.

Removed2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

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

Removed* 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 (OJ L 55, 28.2.2011, p. 13).;’

Removed(10) Article 10 is deleted;

Removed(11) Annex I is replaced by the text in Annex III to this Directive;

Removed(12) Annex II is amended in accordance with Annex IV to this Directive;

Removed(13) in Annex III, point 2(c) is replaced by the following: