[ParlTrack]

Kriton ARSENIS, Dagmar ROTH-BEHRENDT, Csaba Sándor TABAJDI, Jo LEINEN, Justas Vincas PALECKIS, Åsa WESTLUND, Judith A. MERKIES, Nessa CHILDERS, Pavel POC

Proposal for a directive
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.

2012/11/13
Committee: ENVI

Kriton ARSENIS, Dagmar ROTH-BEHRENDT, Csaba Sándor TABAJDI, Jo LEINEN, Justas Vincas PALECKIS, Åsa WESTLUND, Nessa CHILDERS, Pavel POC

Proposal for a directive
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.

2012/11/13
Committee: ENVI

Kriton ARSENIS, Dagmar ROTH-BEHRENDT, Csaba Sándor TABAJDI, Justas Vincas PALECKIS, Åsa WESTLUND, Jo LEINEN, Judith A. MERKIES, Nessa CHILDERS, Pavel POC

Proposal for a directive
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

2012/11/13
Committee: ENVI

Kriton ARSENIS, Dagmar ROTH-BEHRENDT, Åsa WESTLUND, Dan JØRGENSEN, Jo LEINEN, Judith A. MERKIES, Nessa CHILDERS, Pavel POC

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

Directive 2008/105/EC
Article 7 a (new)

3a. The following Article 7a is inserted: ‘Article 7a Coordination 1. The Commission shall ensure a high level of coordination between the Committee established by Article 21(1) of Directive 2000/60/EC and the committees and bodies established in the Union legislation listed in Annex II regarding the evaluation, assessment, authorisation or other review of mutually relevant substances or groups of substances. 2. Such coordination shall ensure an adequate evaluation of the risk to or via the aquatic environment in order to achieve the objectives established under Article 4 of Directive 2000/60/EC and the introduction of measures and controls on the discharges, emissions and losses of the substances to mitigate those risks pursuant to the legislation listed in Annex II. 3. The substances or group of substances for which a significant risk to or via aquatic environment or measures has been identified and controls on the discharges, emissions and losses referred to in paragraph 2 have been introduced shall be made available to the public in electronic form. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 10 concerning the coordination referred to in paragraph 1.’ Or. en (See Amendment 222 to Annex II a (new))

2012/11/13
Committee: ENVI

Kriton ARSENIS, Dagmar ROTH-BEHRENDT, Åsa WESTLUND, Dan JØRGENSEN, Judith A. MERKIES, Nessa CHILDERS, Pavel POC

Proposal for a directive
Annex II a (new)

Directive 2008/105/EC
Annex II (new)

~~(See Amendment 91 to Article 2, point 3a (new) and Amendment 157 to Article 2, point 11)~~ANNEX IIa ‘ANNEX II – Regulation (EC) No. 850/2004 of the European Parliament and of the Council of 29 April 2004; – Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006; – Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998; – Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012; – Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009; – Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009; – Directive 2010/75/EC of the European Parliament and of the Council of 24 November 2010; – Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010;’ – Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010. Or. en

2012/11/13
Committee: ENVI

5 Amendments of Dagmar ROTH-BEHRENDT related to 2011/0429(COD)

ParlTrack - 2011-2024