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Persistence. Atazanavir is potentially persistent.

Bioaccumulation. Weight of evidence for atazanavir does not indicate a significant potential for bioaccumulation.

Toxicity. Atazanavir has low chronic toxicity.

Risk. The use of atazanavir from a European perspective: "No risk has been identified for the surfacewater, groundwater, wastewater treatment plant and sediment compartments as the PEC/PNEC ratios were below the threshold values."


This summary information comes from assessment report for Evotaz (atazanavir, cobicistat) for atazanavir 2015.

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.

Assessment report for Evotaz 2015

Assessment report for Evotaz (atazanavir, cobicistat) for atazanavir, 21 May 2015, EMA/517796/2015.


Persistence: OECD 308.
DT50 water = 14–30 days
% shifting to sediment
>10% at or after 14 days
Degradation products <10%"
Remarks: "Potential P, Risk to sediment dwelling organism.

Bioaccumulation: log Kow
pH 5 = 3.47
pH 7 = 3.30
pH 9 = 3.23
(≤ 4.5)
"Conclusion: Potential B (≥ 3) BCF not available. Weight of evidence does not indicate a significant potential for bioaccumulation."

Chronic toxicity: There are data for 3 trophic levels, most sensitive algae NOEC 4100 microg/L.


The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

Refined PECsurfacewater = 2.6 microg/L.

PNEC = Lowest NOEC, 4100 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 410 microg/L

PEC/PNEC = 0.0063 which gives the risk insignificant.

Assessment report for Evotaz 2021

Assessment report for Evotaz for atazanavir, 20 May 2021, EMA/CHMP/294308/2021, variation (type II).

"Overall, considerations above were considered acceptable and satisfactory by the CHMP, thus no need to update the ERA.

Assessment report for Atazanavir Krka

Assessment report for Atazanavir Krka, 31 January 2019, EMA/119506/2019.

"No Environmental Risk Assessment studies were submitted. This was justified by the applicant as the introduction of Atazanavir Krka hard capsules 150 mg, 200 mg, 300 mg manufactured by Krka is considered unlikely to result in any significant increase in the combined sales volumes for all atazanavir containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar."

Assessment report for Atazanavir Mylan

Assessment report for Atazanavir Mylan, 23 June 2016, EMA/503216/2016.

"No Environmental Risk Assessment (ERA) was submitted. This was justified by the applicant as the introduction of Atazanavir Mylan manufactured by Mylan, is considered unlikely to result in any significant increase in the combined sales volumes for all atazanavir containing products and the exposure of the environment to the active substance. Therefore, the ERA is expected to be similar and not increased."

Scientific discussion about Reyataz, EMEA 2005

"The risk of an adverse environmental impact from use of atazanavir is of no immediate concern based on the results from a Phase I environmental risk assessment. The excipients in the capsules and the other components of the oral powder have been in use for many years and are not expected to pose a significant impact to the environment. Atazanavir is poorly water-soluble and is expected to adsorb to sludge particles to some extent. The PEC for soil is less than the action limit of 10 µg/kg. Additionally, the compound is not toxic to sludge microorganisms at concentrations up to 1000 mg/L, and the PEC/PNEC ratio is less than 1 for aquatic species."

Assessment report for Reyataz 2009

Assessment report for Reyataz, Procedure No. EMEA/H/C/494/II/39.


Persistence: "However ATV (atazanavir, ed. note) appears to be very slowly transformed in aerobic and anaerobic sediments. A complementary Chironomid emergence study (OECD 218) will be undertaken by the MAH and results will be provided as soon as possible in order to give a final conclusion on the environmental risk assessment for ATV."

Bioaccumulation: "The log Kow (between 3.47 and 3.17 depending of pH) did not exceed the limit value (4.5). However, it showed that ATV was moderately lipophilic. In addition, ATV was stable in the environment. This could have triggered a study to evaluate bioconcentration factor in fish, but as the elimination halflife of ATV was short (7 hours) and as it is not requested by the guideline, the lack of this study is acceptable."

Toxicity: No data.


"PEC/PNEC (Predicted No Effect Concentration in surface water) ratios for surface water and groundwater all gave ratios below 1 and for microorganisms well below 0.1, indicating that there are no specific concerns for the environment."

Assessment report for Reyataz 2016

Assessment report for Reyataz, 28 April 2016, EMA/340991/2016, ny beredning.

"An updated environmental risk assessment (ERA) for atazanavir was recently conducted as part of the atazanavir/cobicistat fixed dose combination MAA filing (EVOTAZ, EMEA/H/C/003904). ... The doses of atazanavir (200–300 mg/day) for the new formulation are lower than what was used in the most recent PEC calculation (400 mg/day); accordingly the PEC calculation shown below which uses 400 mg/day can be considered conservative."

Author: Health and Medical Care Administration, Region Stockholm