11 Amendments of Daniela RONDINELLI related to 2019/2816(RSP)
Amendment 12 #
Citation 12 a (new)
- having regard to the Council Conclusions of 26 June 2019 on the next steps towards making the EU a best practice region in combatting antimicrobial resistance,
Amendment 69 #
Recital L
L. whereas there is self-regulation to limit the negative impac iPiE (Intelligent Assessment of pPharmaceuticals in the eEnvironment, such as iPiE (Intelligent Assessment of Pharmaceuticals in the Environment)) Project aims at developing a framework that will provide methodologies to prioritise new and existing medicinal compounds for a comprehensive environmental risk assessment;
Amendment 103 #
Paragraph 8
8. Notes that due to generally low concentrations, risks in drinking water, risks for human health are more related to possible cumulative effects of long-term low-dose exposure than to acute or immediate health effects; is particularly concerned by the endocrine disrupting properties of many pharmaceuticals ending up in the environment;
Amendment 106 #
Paragraph 9
9. Points to the need to regulate pharmaceuticals under water legislation; recalls that interinstitutional negotiations are on-going on a review of the Directive on the quality of water intended for human consumption and on a regulation on minimum requirements for water reuse; Believes that pharmaceuticals should be regulated also in relation to soil. On this regard, it is appropriate that the Commission proposes an overview Directive on soil protection in the EU with specific actions on ways to address soil pollution from pharmaceuticals;
Amendment 165 #
Paragraph 16
16. Considers thatalls on the European Commission to make a legislative proposal to include the environmental impacts of pharmaceuticals could be included into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines;
Amendment 184 #
Paragraph 22
22. Considers that a clear road map for completing environmental risk assessments is needed, where those are not available, in particular for those medicinal products which were authorised before 2006 and were not subject to an Environmental Risk assessment in their market authorisation process;
Amendment 188 #
Paragraph 22 a (new)
22 a. Calls on the Commission to include compulsory environmental criteria in the Good Manufacturing Practice (GMP) framework to give the possibility to EU inspectors to control discharges of third countries pharmaceutical factories supplying the EU;
Amendment 192 #
Paragraph 24
24. Considers it appropriate that pharmaceutical companies submit a joint environmental risk assessment per active substance so as to have coherent information, avoid duplication of work and reducemake concrete steps towards a complete phase out of animal testing;
Amendment 235 #
Paragraph 32
32. Is concerned that monitoring of pharmaceuticals in the environment, notably in soil, is still very limited; stresses the need to strengthen post-marketing control mechanisms into comprehensive monitoring, also with regard to environmental effects, as the current surveillance system (pharmacovigilance) is not adequately and systematically covering the environmental data deficit;
Amendment 237 #
Paragraph 33
33. Calls on the Commission to address the possible impact of pharmaceuticals on the watchlist pursuant to the Water Framework Directive and to assess whether the list should be updated, in particular by including all pharmaceuticals for which an environmental risk has been identified during the authorisation process and by monitoring data in relation to Predicted No Effect Concentration (PNEC) to identify where mitigation measures would be necessary;
Amendment 239 #
Paragraph 33 a (new)
33 a. Calls on the Commission to include pharmaceuticals that pose a significant risk to the environment in the list of priority substances under the Water Framework Directive and set environmental quality standards and concentration limits under the Environmental Quality Standards (EQS) Directive;