15 Amendments of Nessa CHILDERS related to 2011/0429(COD)
Amendment 38 #
Proposal for a directive
Recital 5
Recital 5
(5) 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 (SCHER) and a thorough examination of the toxicity of the substances and their occurrence across the EU.
Amendment 41 #
Proposal for a directive
Recital 6
Recital 6
(6) Numerous Union acts have been adopted since the adoption of Directive 2000/60/EC, which constitute emission control measures in accordance with Article 16 of that Directive for individual priority substances. Moreover, many environmental protection measures fall under the scope of other existing Union legislation. Therefore, priority should be given to implementing and revising existing instruments rather than establishing new controls. The report on the outcome of the regular review of Annex X to Directive 2000/60/EC provided for in Article 16(4) of that Directive should review the measures adopted at the Union level and in Member States and assess whether those measures achieve the quality standards for the priority substances or the cessation objective for the priority hazardous substances. The Commission should accompany this report, if appropriate, with relevant proposals on concrete measures for the achievement of the quality standards and the cessation objective along with intermediate timetables. The inclusion of a substance in Annex X to Directive 2000/60/EC is without prejudice to the application of the provisions 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 and repealing Council Directives 79/117/EEC and 91/414/EEC.
Amendment 47 #
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
Amendment 49 #
Proposal for a directive
Recital 8
Recital 8
(8) Additional substances posing a significant risk to or via the aquatic environment at Union level including pharmaceutical substances have been identified and prioritised using the approaches specified in Article 16(2) of Directive 2000/60/EC and need to 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 these substances. For the derivation of EQS in the regular review of Annex X to Directive 2000/60/EC provided for in Article 16(4) of that Directive, combination effects should be taken into account.
Amendment 51 #
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem. Current evaluation and control of the risk to or via the aquatic environment of medicinal products does not provide adequate attention to Union environmental objectives. An ongoing Commission study on the risks of environmental effects of medicinal products aims therefore at providing an analysis of the relevance of the current legislative framework to, and its effectiveness at, protecting the environment and human health via the aquatic environment, and finally an identification of possible measures to better address the problem.
Amendment 52 #
Proposal for a directive
Recital 8 b (new)
Recital 8 b (new)
(8b) This proposal aims at ensuring a better quality of water for public health and biodiversity reasons. The pharmaceutical substances which have been prioritised are identified due to a significant risk that they pose to or via the aquatic environment at Union level and not due to a risk on public health via human consumption.
Amendment 53 #
Proposal for a directive
Recital 8 c (new)
Recital 8 c (new)
(8c) Control measures which may be taken by the Member States shall take into account the therapeutic importance of the pharmaceutical substances and be in accordance with Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products1 and Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use2. These measures may include take- back and labelling schemes for unused pharmaceuticals. ______________ 1 OJ L 348, 31.12.2010, p. 1 2 OJ L 348, 31.12.2010, p. 74
Amendment 91 #
Proposal for a directive
Article 2 – point 3 a (new)
Article 2 – point 3 a (new)
Directive 2008/105/EC
Article 7 a (new)
Article 7 a (new)
Amendment 96 #
Proposal for a directive
Article 2 – point 4
Article 2 – point 4
Directive 2008/105/EC
Article 8
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. This report shall review the measures adopted at the Union level and in Member States and assess whether those measures achieve the quality standards for the priority substances or the cessation objective for the priority hazardous substances. The Commission shall accompany the report, if appropriate, with relevant proposals on concrete measures for the achievement of the quality standards and the cessation objective along with intermediate timetables. The first review and assessment of the measures shall be submitted to the European Parliament and to the Council by 31 December 2013.
Amendment 109 #
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 1 – subparagraph 2
Article 8 b – paragraph 1 – subparagraph 2
The watch list shall contain no more thanat 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. Priority should be given to those substances where the available monitoring data for the purposes of prioritisation is insufficient. In selecting the substances for the watch list the Commission shall take into account all available information including the results of the prioritisation procedure carried out in the context of the present Directive, 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, 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.
Amendment 126 #
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 2
Article 8 b – paragraph 2
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 10 concerning the drawing up of the watch list referred to in paragraph 1 of this Article. The watch list shall be valid for four years or until a new list is drawn up by the Commission.
Amendment 143 #
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 4 – subparagraph
Article 8 b – paragraph 4 – subparagraph
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 yearbe at least twice per year taking into account the use patterns of the substance.
Amendment 155 #
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 6 a (new)
Article 8 b – paragraph 6 a (new)
6a. The Commission shall provide, in accordance with Article 9 of Regulation (EC) No 1367/2006, for early and effective opportunities for the public to participate in the drawing up of the watch list and the monitoring matrix. The Commission shall make available to the public, in electronic form, all relevant information with a view to its active and systematic dissemination in accordance with Regulation (EC) No 1367/2006.
Amendment 157 #
Proposal for a directive
Article 2 – point 11
Article 2 – point 11
Directive 2008/105/EC
Annexes II and III
Annexes II and III
11. Annexes II and II is replaced by the text set out in Annex IIa to this Directive and Annex III areis deleted. Or. en (See Amendment 222 to Annex II a (new))
Amendment 222 #
Proposal for a directive
Annex II a (new)
Annex II a (new)
Directive 2008/105/EC
Annex II (new)
Annex II (new)