制药工业水污染物排放标准（摘要）（英文）

附件4Discharge standardof water pollutants forpharmaceutical industryrevisedThedischarge standardof pollutantsfor bio-pharmaceutical industryDB31/373-2010has workedforfourteen years.The regulationof airpollutants hasbeen replacedby theemission standardof airpollutantsfrom pharmaceutical industryDB31/310005-

2021.So theleft partabout dischargestandardof water pollutants isrevised here.Abstract1This standardspecifies the requirements fbrwater pollutant discharge control,monitoring,andmanagement inthe pharmaceuticalindustry.The water pollutant dischargecontrol requirementsapply toenterprisesthat discharge water pollutants directly orindirectly beyondtheir legalboundaries.2This standardis applied to themanagement ofwaterpollutant discharged fromexistingpharmaceutical industrialenterprises orproduction facilities,as wellas toenvironmental impactassessment,design ofenvironmental protectionfacilities,completion acceptancefor environmentalprotection,issuance ofpollutant dischargepermits,and dailymanagement ofwaterpollutant dischargesfbr pharmaceuticalindustrial constructionprojects.3This standardis alsoappliedtowaterpollutantdischarge managementfbr pharmaceuticalintermediateenterprises and their production facilities that supply pharmaceutical production,pharmaceuticalresearch institutions and their laboratory facilities,as wellas centralized wastewater treatment facilitiesin thepharmaceuticalindustry.4The waterpollutantdischargecontrol requirementsstipulated in this standardapply topharmaceuticalintermediate enterprisesand theirproductionfacilitiesthatsupplypharmaceuticalproduction,pharmaceutical researchinstitutionsand theirlaboratoryfacilities,and concentrated wastewatertreatment facilities fbr pharmaceuticalindustry thatdischargewaterpollutantsdirectlyor indirectlybeyondtheir legalboundaries.5The effluent limits fbr the first category of pollutants specified in thisstandard areas follows:Table1the EffluentLimits of the firstcategory pollutantsPollutant DischargeNo.Pollutant ApplicableScope MonitoringLocationDischarge Limita,mg/L1Total Cadmium

0.01traditional Chinese medicine2Alkyl MercuryNot detectablemanufacturingand chemical drug3Total Chromium

0.15formulation manufacturingare4Hexavalent Chromium

0.05excludedOutlet of the5Total Selenium

0.05workshop or6Total Arsenic

0.05chemicaldrugformulationworkshop treatment7Total Mercurymanufacturing isexcluded

0.005facility8Total LeadChemical synthesis-based

0.1pharmaceuticals,pharmaceutical9Total Nickelintermediate manufacturingare

0.1excludedaIf thewastewater ofan enterprisecontains anyof thefirstcategorypollutants,the enterprisemust implementclassifiedcollection,dedicated pipelinesfbr transport,and centralizedpre-treatment bypollutant type.If bothwater qualityandquantity aremonitored atthe enterprisesdischarge outletandtheinlet of the concentratedwastewater treatment facilitiesfbr pharmaceuticalindustry,indirect effluent limits can be negotiated.The effluent limits specifiedin this table applytothe outletof centralizedpre-treatment unitsat pharmaceuticalindustry wastewater treatment facilities.6The effluentlimits ofthe second category ofpollutants specifiedin thisstandard areas follows:Table2Effluent limitsfor BasicControl Projectsof SecondCategory PollutantsDischargeLimit,mg/Lcxcluding pHPollutantvalueand colorDischargeNo.Pollutant ApplicableScopeIndirect MonitoringDirectDischarge Discharge3Location1pH DimensionlessAll discharge units6-96-92Color Dilutionfactor All discharge units3060Traditional Chinesemedicine15120manufacturing3Suspended SolidsSS Excluding traditional10120Chinese medicinemanufacturing5-day BiochemicalOxygen All discharge units103004Demand BODDChemicalOxygen DemandAlldischarge units505005CODcrTraditional Chinesemedicine20180manufacturing6Total OrganicCarbon Excludingtraditional15180Chinese medicinemanufacturingAlldischarge units的4057Ammonia NitrogenNH-N8Total NitrogenTN Alldischarge units1520b60Total9Total PhosphorusTP Alldischargeunits

0.58Waste water10Volatile PhenolsAlldischargeunits

0.

21.0DischargeExtraction-based1100pharmaceuticals,biological Outletofthe11Animal andVegetable Oilsdrug manufacturing,Enterprisephannaceutical researchinstitutionsBiologicaldrug

0.515manufacturing,12Anionic SurfactantspharmaceuticalresearchinstitutionsFermentation-based100500pharmaceuticals,extraction-based13Fecal ColiformMPN/LC pharmaceuticals,biologicaldrug manufacturing,pharmaceutical researchinstitutionsTraditionalChinesemedicine

0.

30.3manufacturing14Total CyanidesExcludingtraditionalNot detectable

0.3Chinese medicinemanufacturing15Total ResidualChlorined Alldischargeunits

0.5—a:When thewastewater is discharged intourban concentratedwastewater treatmentfacilities,the indirecteffluent limitsshould match the specified requirement in this table.When thewastewater isdischarged intoother concentratedwastewatertreatment facilities,the indirecteffluentlimitsof items1-9can benegotiated,or meetthe requirementhere ifno agreementis reached;When thewastewater isdischarge into the concentratedwastewater treatmentfacilitiesfbr pharmaceuticalindustry,the item1-

15.can benegotiated,or meetthe requirementhere ifno agreementis reached;b:From Novemberto Februaryofthefollowing year,the effluentlimits inparentheses shall be enforced.c:Indicator microorganismfor disinfection.d:Applicable toprocesses usingchlorine-based disinfection,and requiresa disinfectioncontact timeof1hour inthedisinfection contacttank.e:Represented byeither theminimum ineffectivedilution factoror toxicityunits.Compliance witheither willbeconsidered acceptable.7The characteristiccontrol itemsfbrthesecondcategoryofpollutantsin thisstandard shouldbeselected basedon raw materials,auxiliary materials,production processes,products,by-products,andintermediate productsused.After beingreviewed andconfirmed by the ecologicalenvironmentdepartment,the specifiedeffluentlimitsshallbeimplemented.Table3Effluent limitsfor CharacteristicControl Itemsof SecondCategory PollutantsDischargeLimit,mg/L PollutantDirectDischarge IndirectDischarge3DischargeNo.PollutantMonitoringLocation1Formaldehyde

0.

53.02Methanol

3.

15.3Benzene

0.

020.54Toluene

0.

020.55Total Xylenesb

0.

011.06Adsorbablc OrganicHalides AOX

1.

08.07Dichloromethane

0.

20.28Trichloromethane

0.

0131.0Total Wastewater91,2-Dichloroethane Notdetectable

1.Discharge Outlet101,2-Dichlorobenzene

0.

061.0oftheEnterpriseII Chlorobenzene

0.

060.1512Acetonitrile

2.

05.013Anilines

1.

01.014Nitrobenzenes

2.

02.015Sulfides

1.

01.016Total Copper

0.

51.517Total Zinc

0.

55.0aWhen thewastewater isdischarged intourban concentratedwastewatertreatmentfacilities,the indirecteffluent limitsshouldmatch thespecified requirementinthistable.When thewastewater isdischarged intoother concentratedwastewatertreatmentfacilities,the indirecteffluentlimitsshouldmatchthespecifiedrequirementinthistableWhen thewastewaterisdischargeinto theconcentratedwastewatertreatmentfacilitiesfbrpharmaceuticalindustry,the item1-

15.canbenegotiated,or meettherequirementhere ifno agreementisreached..bIncludes meta-xylene,ortho-xylene,and para-xylene.8From2025,both newand existingpollutantdischargeunits shallmonitor the comprehensive toxicitydischargein their wastewater in accordance with Table4,with monitoringconducted noless thanonce ayear.For directdischarges,except fbrthe acutetoxicity tozebrafish eggs,which mustfollow themonitoringvalues specifiedin Table4,other indicatorsserve as guidance indicators.For indirectdischarges,all monitoringitems inTable4shall serveasguidanceindicators,andthe monitoring resultsshallbe submittedtothelocal ecologicaland environmentalauthorities.Based on the monitoringresults,enterprises shouldtake appropriate control measures to reduce thecomprehensivetoxicity levelofwastewater dischargeand minimizethe impacton theoperation ofcentralizedwastewatertreatmentfacilities andthe surroundingenvironmental quality.Table4Monitoring Valuesfor ComprehensiveToxicity in Waste waterDischargeMonitoring ValuePollutantDischargeNo.Monitoring ItemLIDvalue TUvalue MonitoringLocationAcute Toxicityto Zebrafish621EggsaTotal Wastewater2Luminescent Bacteria88Discharge Outletof theToxicity3Enterprise3Daphnia MagnaToxicity3684Algal Toxicitya1616aThese toxicityindicators arerepresented eitherbytheminimum ineffectivedilution factoror toxicityunits.If eithermeetsthe limitspecifiedinthistable,it isconsidered compliant.8From,2025,both newand existingpollutantdischargeunits shallmonitor pharmaceuticalcomponentdischarge intheirwastewaterinaccordancewithTable5,Based onthemonitoringresults,enterprisesshould takeappropriatecontrolmeasurestoreducethepharmaceuticals dischargedand minimizetheimpact onenvironmental quality.Table5Monitoring valuefor pharmaceuticalsinWastewater DischargePollutantDischargeNo.Monitoring ItemMonitoring ValueMonitoringLocation1Antibiotics aWO.05mg/LTotal WastewaterDischarge Outletof theEnterprisea:Enterprises shouldselect thetypes ofantibiotics tomonitor basedontherawmaterials,production processes,products,by-products,and intermediatesused.Antibiotics forwhich monitoringmethods havealready beenpublished shouldbeincluded.Others willbe incorporatedinto theanalysis afternational pollutantmonitoring andanalysis methodstandardsare released.。