efpia对欧盟委员会在城市废水中分配药物毒性负荷的方法的审查

We support the objectives of the UrbanWastewater Treatment Directive (UWWTD)toprotect the environment and human health. Any regulatory measures aimed at tacklingmicropollution in the context of UWWTD mustbeproportionate, science-basedand complywithPolluter Pays Principle. The European Commission’s assessment of pharmaceutical contributionto urban wastewater toxic load is based on insufficient data and is scientificallyflawed.1 Micropollutantconcentrationin urban wastewater Predicted No-Effect Concentration(PNEC)- the limit below which achemical is unlikely to harm theenvironment Pharmaceutical contribution to the toxic load is overestimated – potentially upto 3 times – due to both overestimating the amount of pharmaceuticals inwastewater and the toxicity that pharmaceuticals have.3 The toxicity of pharmaceuticals was overestimatedby using computer-simulated toxicity estimationswhile ignoring reliable measured data that wascollected using rigorous ECHA/EMA protocols. Telmisartan (anti-hypertension medicine) is~90,000 times less toxicthancomputer-simulated prediction. There are data gaps for 40%of the analysedmicropollutants. Such gaps were filled onlyfor pharmaceuticals,thus inflating pharmaceutical toxic loadcompared to other micropollutants. A lack of representative concentration dataofmicropollutants in urban wastewater hinders anyvalid assessment.4 Each micropollutant was assigned to a singlesector, which is anover-simplistic and biasedapproach. Some micropollutants were falselyassigned to pharmaceutical sector. Some micropollutants (e.g. Chloroxylenol,benzethonium chloride) are attributed onlyto pharmaceuticalsdespite being used byvarious sectors. Ignoring the impact oftertiary treatment,including potential biodegradability ofmicropollutants,inflates the overall toxic load ofmicropollutants. This will also change the contributionof pharmaceuticals to the toxic load. Estimates of "toxic load" are highly sensitive to data availability and quality,underscoring the importance of a thoughtful scientific approach for researchintegrity and informed decision-making. Applying measuredtoxicity datafor telmisartan(anti-hypertensionmedicine) Initial assessment(European CommissionFeasibility Study)1 Further data refinement(applying available measured toxicity data and using estimates for allprojected micropollutants that don’thave measured concentrations) To address the inconsistencies in the assessment of toxic loadin the wastewater and ensure fair implementation of the UWWTD,EFPIA recommends: Developalternative solutionsforEPR implementation thatwould be science-based,proportionate, comply withPolluter Pays Principle andthat do not jeopardise patientaccess to medicines andsecurity of supply. Implement athorough andtransparent reassessmentof the contribution to “toxicload” from various substancesbased on scientific andunbiased approaches. Pause the implementationof the two sector-specificExtended ProducerResponsibility (EPR)provisions.