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Session 4 - Peter Korytar
This document summarizes the state of policy development in the EU to manage contaminants of emerging concern (CECs). It discusses the EU's chemicals legislation and monitoring efforts for CECs in surface water and groundwater. The EU is developing watch lists of substances of concern for surface and groundwater. It is also exploring effect-based monitoring methods and using grouping approaches to assess chemical risks. The document notes efforts to increase data access and sharing, as well as increasing focus on persistent and mobile substances with potential for groundwater contamination. It concludes by mentioning the upcoming EU strategic approach on pharmaceuticals in the environment.
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Session 4 - Peter Korytar
- 1. State of playon policy development to manage CECs in the EU Peter Korytár European Commission, DG Environment, Sustainable chemicals 5 February 2018, OECD, Paris
- 2. EU chemicals legislation Chemicals Environment Products Foodand feed safety Worker protection • Well-developed • Covers CECs to some extent • Scope for improvements
- 3. Monitoring of CECs •Watch lists • Surface water • Ground water
- 4. Monitoring of CECs •Watch lists – surface water – prioritisation methodology
- 5. Monitoring of CECs •Watch lists – surface water – substances 1st Watch List Proposal for 2nd Watch List 17-Alpha-ethinylestradiol (EE2) 17-Alpha-ethinylestradiol (EE2) 17-Beta-estradiol (E2), Estrone (E1) 17-Beta-estradiol (E2), Estrone (E1) Diclofenac Metaflumizone 2,6-Ditert-butyl-4-methylphenol Amoxicillin 2-Ethylhexyl 4-methoxycinnamate Ciprofloxacin Macrolide antibiotics Macrolide antibiotics Methiocarb Methiocarb Neonicotinoids Neonicotinoids Oxadiazon (Chromium VI) Tri-allate -
- 6. Monitoring of CECs •Watch lists – ground water – draft prioritisation methodology All substances Presence in ground water Theoretical groundwater leaching potential and extent of potential environmental exposure Substances with ground water leaching potential Toxicological or eco-toxicological hazard Groundwater Watch List
- 7. Monitoring of CECs •Watch lists – ground water – pharmaceuticals detected (>4 countries) Substance # of States # of sites >LOQ >LOQ Carbamazepine 12 3692 445 12% Sulfamethoxazole 12 2153 105 5% Ibuprofen 9 1865 49 3% Paracetamol 9 1036 248 24% Primidon 4 628 31 5% Phenazone 4 1477 40 3% Iopamidol 4 1462 37 3%
- 8. Monitoring of CECs •Watch lists – ground water – PFCs detected Country Monitored Findings Belgium Yes Yes Switzerland Yes Yes Czech Republic Yes ? France Yes Yes Italy Yes Yes Netherlands Yes Yes Austria Yes Yes Germany Yes Yes Sweden Yes Yes Finland Yes Yes UK Yes Yes
- 9. Monitoring of CECs •Watch lists • Surface water • Ground water European Raptor Biomonitoring Facility • Research funding • More exploratory monitoring is needed
- 10. Facilitating access todata • Occurrence data – Information platform for chemical monitoring (IPCHEM) Access point for discovering, accessing and retrieving chemical occurrence in various media across the world
- 11. Facilitating access todata • Lack of data: • use and production volumes of chemicals • ecotox data • problems with access of data • Occurrence data – Information platform for chemical monitoring (IPCHEM) • Hazard (ecotox) data – in REACH, PPPR and BPR + CLP • Research data – burdensome to get
- 12. Exploring effect-based methods •The monitoring of individual chemicals might be complemented or partly replaced by the monitoring of effects or markers of effects using effect-based methods • Overall – aim to obtain a more holistic picture of water quality, taking into account more substances without significantly increasing monitoring effort • Exploratory work under the common implementation strategy for the WFD • NB – need to be able to identify problem substances/sources to be able to take measures
- 13. Using grouping approaches •Using grouping approaches to prevent existence of CECs or to avoid regrettable substitution • PCBs, dioxins, PFOS substances, PBDEs, PAHs, • PFAS, macrolide antibiotics, neonicotinoids • CMRs, PBTs, vPvBs, EDs • Using more predictive assessments (QSARs, etc) and try to assess substances in groups (whether based on toxicity or on use) ECETOC
- 14. Increasing attention topersistent and mobile substances • Development of a new hazard class to classify/identify substances having potential for groundwater contamination : • Persistent (Half-life) and Mobile (Solubility in water and Log Koc) • Provisional screening of substance (DK EPA + DE UBA) • 2095 substances included in the analysis using DK QSAR DB • P: similar to PBTs; M: Sw > 0.15 mg/L and log Koc < 4.5; T: CMR, STOT RE, classification for effects on or via lactation, DNEL < 9 ug/kg bw/d • 3-18% fulfilled the PM screening criteria • 0.2-3.4% fufilled the PMT screening criteria
- 15. Pharmaceuticals in theenvironment • EU strategic approach to pharmaceuticals in the environment • to be adopted by end May 2018 • possible policy options (not an exclusive list) • covering whole life-cycle of pharma • covering all environmental media • Public consultation still open until 21 Feb https://ec.europa.eu/info/consultations/public-consultation- pharmaceuticals-environment_en
- 16. Pharmaceuticals in theenvironment 4. Promoting greener manufacturing processes 3. Ensuring the scientific robustness, consistency and transparency of risk assessments
- 17.