Environmental information is missing on fass.se for miconazole (2021-09-21). It is voluntary for manufacturers to provide information on environmental impact on fass.se. This summary information is based on previous environmental information on fass.se. Miconazole is monitored within the framework of EU water legislation.
Persistence. Miconazole is potentially persistent.
Bioaccumulation. Miconazole has high potential for bioaccumulation.
Toxicity. Miconazole has high chronic toxicity.
Risk. The use of miconazole (sales data Sweden 2015) has been considered to result in low environmental risk.
Fass environmental information
Fass environmental information for Daktacort (hydrocortisone, miconazole) for miconazole (downloaded 2018-06-27).
Persistence: Miconazole nitrate is potentially persistent.
Bioaccumulation: BCF = 1 949.
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for green algae (Selenastrum capricornutum) NOECr 72 h = 10 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.3455 which gives the risk low.
In selection of algae for toxicity testing of antimicrobials the European Medicines Agency, EMA, recommends test on blue-green algae (cyanobacteria). No information on toxicity on blue-green algae has been found, which means that a calculation of environmental risk becomes uncertain.
Läkemedelsrester i vattenmiljön in Sweden
Miconazole is being tested in Region Stockholm but has been below the quantification limit (LOQ) recently. Miconazole has been detected in outgoing wastewater, surface water and sludge in Sweden.
EU water legislation
Miconazole is monitored within the framework of EU water legislation. "Substances for which doubt exists about their toxicity, or for which the sensitivity, reliability or comparability of the available monitoring methods are not adequate, should not be included in the watch list. The sulfonamide antibiotic sulfamethoxazole and the diaminopyrimidine antibiotic trimethoprim, the antidepressant venlafaxine and its metabolite O-desmethylvenlafaxine, a group of three azole pharmaceuticals (clotrimazole, fluconazole and miconazole) ... The inclusion of the various pharmaceuticals is consistent with the EU Strategic Approach to Pharmaceuticals in the Environment, and the inclusion of the two antibiotics is also consistent with the European One Health Action Plan against Antimicrobial Resistance (AMR), which supports the use of the watch list to ‘improve knowledge of the occurrence and spread of antimicrobials in the environment’."
- European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.
- Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm.
- Stockholm Vatten. Läkemedelsrester i Stockholms vattenmiljö. 2010. ISBN 978-91-633-6642-0.
- IVL Swedish Environmental Research Institute Ltd. Fick J, Lindberg RH, Kaj L, Brorström-Lundén E. Results from the Swedish National Screening Programme 2010. Subreport 3. Pharmaceuticals.
- IVL Swedish Environmental Research Institute Ltd Fick J, Lindberg RH, Fång J, Magnér J, Kaj L, Brorström-Lundén E. Screening 2014. Analysis of pharmaceuticals and hormones in samples from WWTPs and receiving waters. Rapport C 135.
- Official Journal of the European Union. Commission implementing decision (EU) 2020/1161 of 4 August 2020.
- Official Journal of the European Union. Commission implementing decision (EU) 2022/1307 of 22 July 2022.
Author: Health and Medical Care Administration, Region Stockholm