Activities of Sabine WILS related to 2011/0429(COD)

Proposal for a directive
Recital 10 a (new)

(10a) In recent years there has been an increasing focus on the effects on human health and on the environment arising from exposure to many different chemicals. Discharges to the environment during the production, transport, use or disposal often contain a large number of chemicals. The requirements of Directive 2000/60/EC for water bodies to achieve a good chemical status entails a focus not only on the concentration of individual chemicals but also on their effects in combination. It is therefore appropriate to reflect this in the derivation of the EQS.

2012/11/13
Committee: ENVI

Proposal for a directive
Recital 10 b (new)

(10b) The listing of substances as priority substance or priority hazardous substances is based among other things on scientific evaluation of the properties of the substance. In order to safeguard the integrity and credibility of the listing process, political concerns or associated costs of measures should not be used to prevent a substance from being listed as a priority substance or priority hazardous substance, but rather are to be adressed at the subsequent stage after listing a particular substance or group of substances.

2012/11/13
Committee: ENVI

Proposal for a directive
Recital 17

(17) 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 not of sufficient quality for the purpose of risk assessment. The new mechanism should facilitate the gathering of that information across Union river basins. In order to maintain the monitoring costs at reasonable levels, ~~the mechanism should focus on a limited number of subs~~but to ensure that the monitoring is effective, the mechanism should focus on substances with inherent hazard properties and emerging pollutancets, included temporarily in a watch list, and a limited number of monitoring sites, but deliver representative data that are fit for the purpose of the Union prioritisation process. The list should be dynamic, to respond to new information on the potential risks posed by emerging pollutants and avoid monitoring substances for longer than necessary.

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 2

Directive 2008/105/EC
Article 3 – paragraph 1 – subparagraph 1 a (new)

As from 1 January 2015 Member States shall apply the EQS values for priority hazardous substances laid down in Part A of Annex I to this Directive in bodies of surface water, reduced by the following factors or at least at the detection level given readily available measurement technology: a) As from 22 December 2015 by a reduction factor of 10; b) As from 22 December 2021 by a factor reduction of 20; c) As from 22 December 2027 by a factor of 100.

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 2

Directive 2008/105/EC
Article 3 – paragraph 7

7. The Commission shall examine technical and scientific progress, including the conclusion of risk assessments as referred to in Article 16(2)(a) and (b) of Directive 2000/60/EC and information from the registration of substances ~~made publicly available according to Article 119 of Regulation (EC) No 1907/2006, and,~~registered according to Regulation (EC) No 1907/2006, including the potential for diffuse emissions from uses in articles, 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 of the Treaty in line with the timetable provided for in Article 16(4) of Directive 2000/60/EC.

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 3 a (new)

Directive 2008/105/EC
Article 5 a (new)

3a. The following Article 5a is inserted: ‘Article 5a Controlling priority substances that are industrial chemicals 1. For all priority substances and priority hazardous substances which fall within the scope of Regulation (EC) No 1907/2006 (REACH) and which in the Commission's opinion meet the criteria in Article 57 of that Regulation, the Commission shall ask the European Chemicals Agency (ECHA) by [OJ to insert date: one year after the entry into force of the directive] to prepare dossiers pursuant to Article 59(2) or Article 69(1) of that Regulation, if this has not already been done. 2. For those substances which in the Commission's opinion do not meet the criteria in Article 57 of that Regulation, the Commission shall ask ECHA by [OJ to insert date: one year after the entry into force of the directive] to prepare dossiers pursuant to Article 69(1) of that Regulation, if this has not already been done. 3. When monitoring data show that additional EU-level measures are necessary for an existing priority or priority hazardous substance to ensure compliance with Directive 2000/60/EC, the Commission shall take action in accordance with paragraphs 1 and 2 of this Article, or review an authorisation granted pursuant Article 61(2) of Regulation (EC) No 1907/2006, or review a restriction pursuant to Article 68(1) of Regulation (EC) No 1907/2006, whatever is applicable.’

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 3 b (new)

Directive 2008/105/EC
Article 5 b (new)

3b. The following Article 5b is inserted: ‘Article 5b Controlling priority substances that are plant protection products 1. Member States shall review by [OJ to insert date: one year after the entry into force of the directive] all product authorisations based on Regulation (EC) No 1107/2009 for plant protection products containing priority substances pursuant to Article 44 of that Regulation to ensure that they are consistent with the objectives of Directive 2000/60/EC . 2. Member States shall review the relevant authorisations granted for plant protection products containing an existing priority substance based on Regulation (EC) No 1107/2009 pursuant to Article 48 of that Regulation when monitoring data show that additional EU-level measures are necessary for consistency with the objectives of Directive 2000/60/EC within one year after the publication of the monitoring data. 3. Priority hazardous substances shall be deemed not to satify the criteria under points 3.6.2, 3.6.3, 3.6.4, 3.6.5, 3.7.2 or 3.8.2 of Annex II of that Regulation. 4. Exceedance of the EQS shall be deemed to be an unacceptable effect on the environment pursuant to Article 4(3)(e)(i) of that Regulation.’

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 3 c (new)

Directive 2008/105/EC
Article 5 c (new)

3c. The following Article 5c is inserted: ‘Article 5c Controlling priority substances that are biocidal products 1. Member States, or in the case of a Union authorisation, the Commission, shall review by [OJ to insert date: one year after the entry into force of the directive] all authorisations granted based on 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 products1, pursuant to Article 48 of that Regulation for biocidal products containing priority substances to ensure that they are consistent with the objectives of Directive 2000/60/EC. 2. Member States, or in the case of a Union authorisation, the Commission, shall review the relevant authorisations granted for an existing priority substance based on Regulation (EC) No 528/2012 pursuant to Article 48 of that Regulation when monitoring data show that additional EU-level measures are necessary for consistency with the objectives of Directive 2000/60/EC within one year after the publication of the monitoring data. 3. Priority hazardous substances shall be deemed to meet one of the exclusion criteria defined in Article 5(1) of that Regulation. 4. Exceedance of the EQS shall be deemed to be an unacceptable effect on the environment pursuant to Article 19(1)(b)(iv) of that Regulation.’ ____________________ 1 OJ L 167, 27.6.2012, p. 1

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 3 d (new)

Directive 2008/105/EC
Article 5 d (new)

3d. The following Article 5d is inserted: ‘Article 5d Controlling priority substances in industrial emissions For priority substances falling under the scope of Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control)1, for which Article 10 of Directive 2000/60/EC foresees the application of emission limit values and emissions controls based on best available techniques, the Commission shall include consideration of the monitoring data obtained under Directive 2000/60/EC in its regular review of the adequacy of those values and techniques. Where improvements are necessary, appropriate legislative action should be taken pursuant to Article 73(1) of that Directive.’ ___________________ 1 OJ L 334, 17.12.2010, p. 17

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 3 e (new)

Directive 2008/105/EC
Article 5 e (new)

3e. The following Article 5e is inserted: ‘Article 5e Controlling priority substances that are used as pharmaceuticals 1. For priority substances falling under the scope of 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 use1, Member States shall assess within one year after entry into force of this Directive whether the summary of product characteristics as well as the patient information leaflet will raise awareness sufficently to contribute effectively to achieving the objectives of this Directive. For priority substances falling under the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency2 , the Commission, based on an opinion from the European Medicines Agency, shall assess within one year after entry into force of this Directive whether the summary of product characteristics as well as the patient information leaflet will raise awareness sufficently to contribute effectively to achieving the objectives of this Directive. To ensure transparency, the environmental risk assessments of priority substances shall be made publicly available in the context of pharmaceutical legislation. 2. Member States or, in the case of a Union authorisation, the Commission shall review the relevant authorisations granted for pharmaceutical substances or products containing an existing priority substance when monitoring data show that additional EU-level measures are necessary for consistency with the objectives of Directive 2000/60/EC within one year after the publication of the monitoring data. 3. For priority substances falling under the scope of Directive 2001/83/EC or Regulation (EC) No 726/2004, the Commission shall encourage Member States to consider making pharmaceutical products containing them subject to prescription. 4. Member States shall report to the Commission within one year after entry into force of this Directive that appropriate collection systems are in place for medicinal products that are unused or have expired pursuant to Article 127b of Directive 2001/83/EC.’ ______________ 1 OJ L 311, 28.11.2001, p. 67 2 OJ L 136, 30.4.2004, p. 1

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 4

Directive 2008/105/EC
Article 8

The Commission shall report to the European Parliament and to the Council 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, if appropriate, with relevant proposals, 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. In the derivation of the EQS value for individual substances, a mixture uncertainty of 100 should be integrated.

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 6

Directive 2008/105/EC
Article 8 b – paragraph 1 – subparagraph 2

The watch list shall contain ~~no more than~~at least 25 substances or groups of substances at any given time and shall indicate the monitoring matrix for each substance. The substances shall be selected from among those for which the available information indicates that they may pose a significant risk at Union level to or via the aquatic environment. In selecting the substances for the watch list the Commission shall take into account all available information including research projects, Member States' characterisation and monitoring programmes under Articles 5 and 8 of Directive 2000/60/EC and information on production volumes, use patterns, intrinsic properties, particle size, concentrations in the environment and effects, including that gathered in accordance with Directives 98/8/EC, 2001/82/EC and 2001/83/EC of the European Parliament and of the Council, and with Regulation (EC) No 1907/2006 and Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 6

Directive 2008/105/EC
Article 8 b – paragraph 4 – subparagraph 3

In selecting the representative stations, the monitoring frequency and timing for each substance, Member States shall take into account the use patterns of the substance. The frequency of monitoring shall not be less than ~~once~~five times per year.

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 6

Directive 2008/105/EC
Article 8 b – paragraph 5

5. Member States shall report the results of the monitoring carried out under paragraph 4 to the Commission within 182 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 station and monitoring strategy. If the results of the monitoring demonstrate that the substances in the watch list is detected in at least 3 Member States, and may give rise to concern, the Commission shall include it in Annex I and take the appropriate control measures.

2012/11/13
Committee: ENVI

Proposal for a directive
Annex I – table – row 3 Directive 2000/60/EC

(3) 1912-24-9 217-617-8 Atrazine X

2012/11/13
Committee: ENVI

Proposal for a directive
Annex I – table – row 20

Directive 2000/60/EC
Annex X – table – row 20

(20) 7439-92-1 231-100-4 Lead and its compounds X

2012/11/13
Committee: ENVI

Proposal for a directive
Annex I – table – row 46

Directive 2000/60/EC
Annex X – table – row 46

(46) 57-63-6 200-342-2 17alpha-ethinylestradiol X

2012/11/13
Committee: ENVI

Proposal for a directive
Annex I – table – row 47

Directive 2000/60/EC
Annex X – table – row 47

(47) 50-28-2 200-023-8 17beta-estradiol X

2012/11/13
Committee: ENVI

Proposal for a directive
Annex I – table – row 48 a (new)

Directive 2008/105/EC
Annex X – table – row 48 a (new)

(48a) 1071-83-6 not applicable Glyphosate X

2012/11/13
Committee: ENVI

Proposal for a directive
Annex II – table – row 48 a (new)

Directive 2008/105/EC
Annex I – table – row 48 a (new)

(48a) Glyphosate 1071-83-6 not not not not applicable applicable applicable applicable

2012/11/13
Committee: ENVI

Proposal for a directive
Article 2 – point 2 a (new)

Directive 2008/105/EC
Article 4 – paragraph 3 – point b a (new)

2a. The following point shall be added to Article 4(3): ‘(ba) and to be phased out within the period of one management cycle.’

2012/11/08
Committee: ENVI

Proposal for a directive
Article 2 – point 3 a (new)

Directive 2008/105/EC
Article 7 – paragraph 1 – subparagraph 1 a (new)

3a. The following subparagraph shall be added to Article 7(1): ‘This assessment shall in particular address necessary efforts in accordance with Article 16(6) having regard to the effectiveness of the measures which have been introduced by the member states pursuant to Article 9, 10 and 16(8) of Directive 2000/60/EC.’

2012/11/08
Committee: ENVI

Proposal for a directive
Article 2 – point 4

Directive 2008/105/EC
Article 8

The Commission shall report to the European Parliament and to the Council the outcome of the regular review of Annex X to Directive 2000/60/EC provided for in Article 16(4) of that Directive every 4 years. It shall accompany the report, if appropriate, with relevant proposals, 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. In the derivation of the EQS value for individual substances, a mixture uncertainty of 100 should be integrated. Or. en (Replaces amendment 94)

2012/11/08
Committee: ENVI

Proposal for a directive
Article 2 – point 6

Directive 2008/105/EC
Article 8 b – paragraph 4 – subparagraph 3

In selecting the representative stations, the monitoring frequency and timing for each substance, Member States shall take into account the use patterns of the substance. The frequency of monitoring shall not be less than ~~once per year.~~ five times per year, with a minimum interval of 2 months. Or. en (Replaces amendment 141)

2012/11/08
Committee: ENVI