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Improving Environmental Risk Assessment of Human Pharmaceuticals
KTH, School of Biotechnology (BIO), Industrial Biotechnology.
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2015 (English)In: Environmental Science and Technology, ISSN 0013-936X, E-ISSN 1520-5851, Vol. 49, no 9, 5336-5345 p.Article in journal (Refereed) Published
Abstract [en]

This paper presents 10 recommendations for improving the European Medicines Agency's guidance for environmental risk assessment of human pharmaceutical products. The recommendations are based on up-to-date, available science in combination with experiences from other chemical frameworks such as the REACH-legislation for industrial chemicals. The recommendations concern: expanding the scope of the current guideline; requirements to assess the risk for development of antibiotic resistance; jointly performed assessments; refinement of the test proposal; mixture toxicity assessments on active pharmaceutical ingredients with similar modes of action; use of all available ecotoxicity studies; mandatory reviews; increased transparency; inclusion of emission data from production; and a risk management option. We believe that implementation of our recommendations would strengthen the protection of the environment and be beneficial to society. Legislation and guidance documents need to be updated at regular intervals in order to incorporate new knowledge from the scientific community. This is particularly important for regulatory documents concerning pharmaceuticals in the environment since this is a research field that has been growing substantially in the last decades.

Place, publisher, year, edition, pages
2015. Vol. 49, no 9, 5336-5345 p.
Keyword [en]
Occupational-Exposure Limits, Aquatic Environment, Prioritizing Pharmaceuticals, Antibiotic-Resistance, Estrogenic Chemicals, Water-Pollution, Public-Health, Fish, Management, Organisms
National Category
Environmental Sciences Ecology
URN: urn:nbn:se:kth:diva-169269DOI: 10.1021/acs.est.5b00302ISI: 000354155800012PubMedID: 25844810OAI: diva2:821276
Mistra - The Swedish Foundation for Strategic Environmental Research

QC 20150615

Available from: 2015-06-15 Created: 2015-06-12 Last updated: 2015-06-15Bibliographically approved

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