title: Improving environmental risk assessment of human pharmaceuticals.
abstract: 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.
authors.affiliation: †Department of Environmental Science and Analytical Chemistry, Stockholm University, Stockholm SE-106 91, Sweden.
authors.forename: Marlene
authors.initials: M
authors.lastname: Ågerstrand
authors.affiliation: ‡Department of Environmental Toxicology, Uppsala University, Uppsala SE-752 36, Sweden.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Berg
authors.affiliation: §Division of Industrial Biotechnology, Royal Institute of Technology, Stockholm SE-106 91, Sweden.
authors.forename: Berndt
authors.initials: B
authors.lastname: Björlenius
authors.affiliation: †Department of Environmental Science and Analytical Chemistry, Stockholm University, Stockholm SE-106 91, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Breitholtz
authors.affiliation: ‡Department of Environmental Toxicology, Uppsala University, Uppsala SE-752 36, Sweden.
authors.forename: Björn
authors.initials: B
authors.lastname: Brunström
authors.affiliation: ∥Department of Chemistry, Umeå University, Umeå SE-901 87, Sweden.
authors.forename: Jerker
authors.initials: J
authors.lastname: Fick
authors.affiliation: ⊥Department of Infectious Diseases, Institute of Biomedicine, University of Gothenburg, Göteborg SE-405 30, Sweden.|#Department of Biosciences, College of Life and Environmental Sciences, University of Exeter, Exeter EX4 4QD, United Kingdom.
authors.forename: Lina
authors.initials: L
authors.lastname: Gunnarsson
authors.affiliation: ⊥Department of Infectious Diseases, Institute of Biomedicine, University of Gothenburg, Göteborg SE-405 30, Sweden.
authors.forename: D G Joakim
authors.initials: DG
authors.lastname: Larsson
authors.affiliation: ∇Institute for the Environment, Brunel University, Uxbridge UB8 3PH, United Kingdom.
authors.forename: John P
authors.initials: JP
authors.lastname: Sumpter
authors.affiliation: ∥Department of Chemistry, Umeå University, Umeå SE-901 87, Sweden.
authors.forename: Mats
authors.initials: M
authors.lastname: Tysklind
authors.affiliation: †Department of Environmental Science and Analytical Chemistry, Stockholm University, Stockholm SE-106 91, Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Rudén
mesh_terms: D004777:Environment; D004785:Environmental Pollutants / Q000032:analysis* / Q000633:toxicity; D006801:Humans; D007221:Industry; D004364:Pharmaceutical Preparations / Q000032:analysis*; D018570:Risk Assessment
chemical_list: D004785:Environmental Pollutants; D004364:Pharmaceutical Preparations