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Open Access Content loaded within last 14 days Challenges of Regulatory Environmental Risk Assessment for Human Pharmaceuticals with Focus on Antibiotics

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This article is Open Access under the terms of the Creative Commons CC BY-NC licence.

Just recently the problem of pharmaceutical residues in the environment has been emphasized by OECD. Especially antibiotics are of concern due to their widespread use and diverse modes of actions including ones that can affect the photosynthetic activity of primary producers and subsequently primary biomass production and carbon dioxide fixation. The EU regulatory authority, the European Medicines Agency (EMA), has therefore proposed to implement a new tailored environmental risk assessment scheme, published in a new draft guideline 2018. Threshold effect levels to three fixed representative species of green algae and cyanobacteria will be required. This article reviews and compares the contamination of waters with antibiotics in Switzerland and Germany and also presents an overview of published effect data on eukaryotic algae and prokaryotic cyanobacteria in order to discuss the representativeness of the selected species. Since no full datasets as demanded by the EMA were publically available yet, the gaps for four antibiotics have been experimentally completed. In summary the results support the species selection of the EMA published in the revised draft guideline, however it remains unclear whether diatoms should also be considered.
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Keywords: ANTIBIOTICS; ENVIRONMENTAL RISK ASSESSMENT (ERA); EU REGULATION; HUMAN PHARMACEUTICALS; MEASURED ENVIRONMENTAL CONCENTRATION (MEC)

Document Type: Research Article

Affiliations: 1: Innovative Environmental Services (IES) Ltd, Benkenstrasse 260, CH-4108 Witterswil, Switzerland;, Email: [email protected] 2: Innovative Environmental Services (IES) Ltd, Benkenstrasse 260, CH-4108 Witterswil, Switzerland

Publication date: March 1, 2020

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  • International Journal for Chemistry and Official Membership Journal of the Swiss Chemical Society (SCS) and its Divisions

    CHIMIA, a scientific journal for chemistry in the broadest sense, is published 10 times a year and covers the interests of a wide and diverse readership. Contributions from all fields of chemistry and related areas are considered for publication in the form of Review Articles and Notes. A characteristic feature of CHIMIA are the thematic issues, each devoted to an area of great current significance.

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