AMR Alliance Science-Based PNEC Targets for Risk Assessments
The members of the AMR Industry Alliance have developed a unified approach to establishing discharge
targets for antibiotic manufacturing, based on Predicted No‐Effect Concentrations (PNECs) for use in
environmental risk assessments of antibiotics. The discharge target can be derived using these PNECs and
site-specific parameters. The publication of the PNEC table fulfills the commitment of the AMR Industry
Alliance to publish science-driven, risk-based targets for discharge concentrations of antibiotics. For the
first time, the pharmaceutical industry, as member companies of the Alliance, have collated, shared,
analyzed, and published existing antibiotic data with respect to antimicrobial resistance and eco-toxicity.
The PNEC table contains two values. PNEC‐Environment (PNEC‐ENV) values are based on eco-toxicology
data generated by Alliance member companies and relevant peer reviewed literature. These values are
intended to be protective of ecological species and incorporate assessment factors consistent with
standard environmental risk methodologies (Brandt et al., 2015[1]; Le Page et al., 2017[2]). The PNEC‐
Minimum Inhibitory Concentration (PNEC‐MIC) values are based on the approach published in Bengtsson‐
Palme and Larsson (2016)[3] and are intended to be protective of resistance promotion. This table will be
updated periodically as new reliable and robust data become available.
The release of this table is an important step in the journey of evaluating antibiotic discharge
concentrations using science-driven, risk-based targets, allowing Alliance member companies to work
toward achieving these target values at the receiving water body. The AMR Industry Alliance
recommendation is that companies target the lower of these two values (when available) for assessing
manufacturing site discharges under a risk‐based framework.
If an antibiotic is not listed in the table, read-across to a similar antibiotic based on chemical structure or
mode of action can be made.[4] Alternatively, based on a statistical assessment of all available data, a
default PNEC in the absence of both a PNEC-ENV and PNEC-MIC of 0.05 µg/L can be leveraged as a target.[5]
When available, a compound specific PNEC-ENV, PNEC-MIC or the lowest of both values should be used.
If no data are available, a default PNEC of 0.05 µg/L should be used.
The AMR Industry Alliance believes working toward achieving these antibiotic discharge concentration
targets will be both protective of ecological resources and also lower the potential for the evolution and
selection of AMR in the environment. It is important to note that these values are recommended based
on currently available information, thus, may change as new reliable and relevant information generated
to recognized protocols comes to light.
[1]
Brandt, et al., 2015. Ecotoxicological assessment of antibiotics: A call for improved consideration of microorganisms. Environment
International, 85: 189–205.
[2]
Le Page, et al., 2017. Integrating human and environmental health in antibiotic risk assessment: A critical analysis of protection goals, species
sensitivity and antimicrobial resistance. Environment International, 109: 155–169.
[3]
Bengtsson‐Palme & Larsson, 2016. Concentrations of antibiotics predicted to select for resistant bacteria: Proposed limits for environmental
regulation, Environment International 86: 140–149.
[4]
Grouping of substances and read-across - ECHA (europa.eu)
[5]
Vestel, et al., 2022. Default Predicted No Effect Target Concentrations for Antibiotics in the Absence of Data for the Protection Against
Antibiotic Resistance and Environmental Toxicity, IEAM 10.1002/ieam.4560
Revision Date: 22-February-2023
AMR Alliance Science-Based PNEC Targets for Risk Assessments
Active Pharmaceutical PNEC-ENV PNEC-MIC Lowest Value
Ingredient (µg/L) (µg/L) (µg/L)
Amikacin Testing On-Going 16 16
Amoxicillin 0.57 0.25 0.25
Ampicillin 0.6 0.25 0.25
Avilamycin 125 8 8
Azithromycin 0.03 0.25 0.03
Aztreonam N/A 0.5 0.5
Bacitracin 115 8.0 8.0
Bedaquiline 0.08 N/A 0.08
Benzylpenicillin 1 0.25 0.25
(Penicillin G) 1
Capreomycin N/A 2 2
Cefaclor N/A 0.5 0.5
Cefadroxil 0.14 2 0.14
Cefalonium 21 N/A 21
Cefaloridine N/A 4 4
Cefalothin N/A 2 2
Cefazolin Testing On-Going 1 1
Cefdinir N/A 0.25 0.25
Cefepime 1.3 0.5 0.5
Cefixime 0.6 0.06 0.06
Cefoperazone N/A 0.5 0.5
Cefotaxime 0.12 0.13 0.12
Cefoxitin N/A 8 8
Cefpirome N/A 0.06 0.06
Cefpodoxime proxetil 1.8 0.25 0.25
Cefquinome 1.6 N/A 1.6
Ceftaroline 0.12 0.06 0.06
Ceftazidime 1.3 0.5 0.5
Ceftibuten N/A 0.25 0.25
Ceftiofur 0.4 0.06 0.06
Ceftobiprole 0.23 0.25 0.23
Ceftolozane 1.9 N/A 1.90
Ceftriaxone 0.33 0.03 0.03
1
Corrected 25-May-2023: Benzylpenicillin and Penicillin G were incorrectly displayed as different entries.
Revision Date: 22-February-2023
Active Pharmaceutical PNEC-ENV PNEC-MIC Lowest Value
Ingredient (µg/L) (µg/L) (µg/L)
Cefuroxime 1.7 0.5 0.5
Cephalexin 0.21 4 0.21
Cephradine 0.19 N/A 0.19
Chloramphenicol N/A 8 8
Chlortetracycline 5 N/A 5
Ciprofloxacin 0.45 0.06 0.06
Clarithromycin 0.25 0.25 0.25
Clinafloxacin N/A 0.5 0.5
Clindamycin 0.1 1 0.1
Cloxacillin 20 0.13 0.13
Colistin (Polymyxin E) 9 2 2
Daptomycin 510 1 1
Delamanid 0.03 N/A 0.03
Doripenem 0.46 0.13 0.13
Doxycycline 25 2 2
Enramycin 4.8 N/A 4.8
Enrofloxacin 1.9 0.06 0.06
Ertapenem 14 0.13 0.13
Erythromycin 0.5 1 0.5
Ethambutol Testing On-Going 2 2
Faropenem N/A 0.02 0.02
Fidaxomicin 891 0.02 0.02
Florfenicol 38 2 2
Flucloxacillin 27 N/A 27
Flumequine N/A 0.25 0.25
Fosfomycin 52 2 2
Fusidic acid N/A 0.5 0.5
Framycetine Testing On-Going 0.06 0.06
Gamithromycin 0.24 N/A 0.24
Gatifloxacin N/A 0.13 0.13
Gemifloxacin N/A 0.06 0.06
Gentamicin 0.15 1 0.15
Imipenem 0.41 0.13 0.13
Isoniazid 1290 0.13 0.13
Kanamycin 1.1 2 1.1
Levofloxacin 1.5 0.25 0.25
Revision Date: 22-February-2023
Active Pharmaceutical PNEC-ENV PNEC-MIC Lowest Value
Ingredient (µg/L) (µg/L) (µg/L)
Lincomycin 0.81 2 0.81
Linezolid 3.5 8 3.5
Loracarbef N/A 2 2
Mecillinam N/A 1 1
Meropenem 1.5 0.06 0.06
Metronidazole N/A 0.13 0.13
Minocycline 1.1 1 1
Moxifloxacin N/A 0.13 0.13
Mupirocin N/A 0.25 0.25
Nalidixic acid N/A 16 16
Narasin N/A 0.5 0.5
Natamycin 210 N/A 210
Neomycin 0.03 2 0.03
Netilmicin N/A 0.5 0.5
Nitrofurantoin N/A 64 64
Norfloxacin 120 0.5 0.5
Novobiocin 20 N/A 20
Ofloxacin 10 0.5 0.5
Oxacillin N/A 1 1
Oxytetracycline 47 0.5 0.5
Pefloxacin N/A 8 8
Penicillin G Procaine 16 N/A 16
Penicillin V 3 0.06 0.06
(phenoxymethylpenicillin)2
Piperacillin 4.3 0.5 0.5
Polymyxin B 0.06 N/A 0.06
Pristinamycin 71 N/A 71
Puromycin 31 N/A 31
Retapamulin N/A 0.06 0.06
Rifampicin 4 0.06 0.06
Rifamycin 1 N/A 1
Rifaximin 0.11 N/A 0.11
Roxithromycin 6.8 1 1
Secnidazole N/A 1 1
Sparfloxacin N/A 0.06 0.06
2
Corrected 25-May-2023: Phenoxymethylpenicillin and Penicillin V were incorrectly displayed as different entries.
Revision Date: 22-February-2023
Active Pharmaceutical PNEC-ENV PNEC-MIC Lowest Value
Ingredient (µg/L) (µg/L) (µg/L)
Spectinomycin N/A 32 32
Spiramycin 1.1 0.5 0.5
Streptomycin N/A 16 16
Sulfadiazine 11 N/A 11
Sulfamethoxazole 6.6 16 6.6
Sulfanilamide 230 N/A 230
Tedizolid 3.2 N/A 3.2
Teicoplanin 13 0.5 0.5
Telithromycin Testing On-Going 0.06 0.06
Tetracycline 3.2 1 1
Thiamphenicol N/A 1 1
Tiamulin N/A 1 1
Ticarcillin N/A 8 8
Tigecycline 0.1 1 0.1
Tildipirosin 0.42 N/A 0.42
Tilmicosin 0.8 1 0.8
Tobramycin 4 1 1
Trimethoprim 928 0.5 0.5
Trovafloxacin N/A 0.03 0.03
Tulathromycin 0.04 N/A 0.04
Tylosin 1 4 1
Vancomycin 14 8 8
Viomycin N/A 2 2
Virginiamycin N/A 2 2
Revision Date: 22-February-2023
