NORMAN Association N° W The NORMAN approach for setting priorities among emerging contaminants in Europe Working Group 1 Valeria Dulio (INERIS), Peter C. von der Ohe (UFZ), Jaroslav Slobodnik (EI) and NORMAN Prioritisation WG

NORMAN list of emerging substances (update 2011) More than 700 substances –Selected by the NORMAN experts, based on citations in the scientific literature and expert judgmen t Algal toxins Anticorrosives Antifoaming agents Antifouling compounds Antioxidants Biocides Complexing agents Detergents Disinfection by-products Flame retardants Fragrances Gasoline additives Industrial solvents Engineered Nanoparticles Perfluoroalkylated substances Personal care products Pesticides Pharmaceuticals Wood preservatives Need to set priorities !

Prioritisation of emerging substances Emerging substances often overlooked with conventional prioritisation methodologies NORMAN prioritisation scheme –Designed specifically for emerging substances : –Knowledge gaps –Actions needed

NORMAN Association N° W Priority Substances in each action category List of emerging substances Hazard assessment Exposure assessment Criteria Ranking of substances within each category - Data collection & Validation Allocation of substances to action categories Review process A specific set of indicators for each category Risk assessment

CATEGORISATION: what are the actions needed?

Six action categories 1. Sufficient exposure/hazard info - risk: Candidate PS/RBSP 6. Sufficient exposure/hazard info – no risk: Reduce monitoring efforts 2. Lack of exposure info: Screening campaigns 3. Lack of ecotox info: Hazard assessment (PNEC) 4. LOQ > PNEC/EQS: Improvement of analytical methods NORMAN Association N° W Lack of exposure AND ecotox info: Screening AND hazard assessment

Classification into Action categories Availability of experimental data for EQS derivation? Univers of substances (NORMAN list) Cat. 3: Action (eco)tox MEC95 > PNEC ? LOQs expert labs < PNEC ? no yes Cat. 1: Candidates ecological status Cat. 6: non priority for regular monitoring Cat. 4: Action Analytical no Availability of experimental data for EQS derivation ? no yes Cat. 2: Screening study yes no >4 countries AND /OR > 100 sites with analysis >20 sites analysis > LOQ in the relevant matrix(ces) + Recent data (>last 6 years) Suff. investigated and quantified in the relevant matrix Suff. investigated but low frequency of quantification Insuff. (or never) investigated OR measured in the „wrong“ matrix LOQ < PNEC (existing data in the database)? All data <LOQ no yes Cat. 5 Novel end points

MEC 95 and Lowest PNEC  Risk ratio MEC 95 / Lowest PNEC (to identify potential risk)  MEC 95 Take the maximum concentration at each site (MEC max _ site ) Calculate 95th percentile of all MEC max_site values (MEC95)  Lowest PNEC Predict missing acute toxicity data with read-across models (see kNN read-across methodology Schüürmann et al. 2011, EST, DOI: /es200361rf) Use Lowest value of PNEC acute (lowest LC50 / 1000) and PNEC chronic (Lowest NOEC / 100), instead of preferring chronic over acute data per se

Lowest PNEC Lowest value of available PNEC acute and PNEC chronic for hazard assessment, instead of preferring chronic over acute data per se STD = standard test data Ecotoxicological database Sufficient chronic data ?Sufficient acute data ? STD PNEC acute PNEC chronic Yes P-PNEC No Lowest PNEC

PRIORITISATION WITHIN EACH CATEGORY

Prioritisation indicators Exposure indicators: N° of countries/sites with analyses, frequency of quantif. Use pattern (applied in the environment, diffuse sources, point sources) PBT, vPvB properties Hazard indicators (effects on ecosystems and human health) : Novel end points (behavioural effects) CMR properties (4 classes according to EU classification) Endocrine disruption potential Risk indicators: –Frequency of exceedence of the PNEC (spatial exposure) –Extent of exceedance of the PNEC (intensity of impact)

Collected data Kow (partit. coeff. octanol/ water)692 / 707 subst. (INERIS) Koc (adsorption coeff.)691/ 707 subst. (INERIS) S (hydrosolubility)693 / 707 subst. (INERIS) Fugacity models559 / 707 subst. (UFZ) PNEC (P-PNEC) water/ sed / biota (experim. data + calculated values * ) 707 / 707 subst. (UFZ, INERIS) Monitoring data (EMPODAT database) data for 359 substances (NORMAN members) LOQ (analytical performance)Available in the NORMAN DB + litterature search and expert labs for > 400 substances (INERIS, NORMAN members) Classification PBT, vPvB, CMR, ED693 /707 ~ 700 tests ~ 1100 tests ~550 tests * kNN read-across methodology, Schüürmann et al. 2011, EST DOI: /es200361r)

NORMAN scheme applied for assessment of 500 substances within FP6 Modelkey project Monitoring data provided by: Joint Danube Survey (JDS2) and four regional water authorities (Elbe, Scheldt and Llobregat river basins) von der Ohe et al. 2011, STOTEN, doi.org/ /j.scitotenv

NORMAN scheme applied in France Water monitoring campaign 2012 (INERIS, ONEMA) Improve info about less investigated substances Prepare future revision of RB specific pollutants list (WFD) TOP PRIORITY subst. : 221 water and 370 in sediment Improvement of analytical performance (CAT.4) Screening study (CAT.2) 2316 candidates subst. (700 already part of national monitoring)

20 top priority subst. (FR) with LOQ > PNEC

NORMAN prioritisation approach applied successfully at the national and international river basin level; Coming soon: results of the prioritisation exercise applied to NORMAN List of emerging substances; Further data sharing at EU level to identify reliably new EU priority substances: all data on emerging substances generated in Europe should end up in one database; Interested to share your data to improve prioritisation of emerging substances ? Contact Valeria Dulio at

NORMAN WG on Prioritisation of Emerging Substances: Valeria Dulio, Sandrine Andres, INERIS Peter von der Ohe, Werner Brack, UFZ - Leipzig Jaroslav Slobodnik, Environmental Institute Heinz Ruedel, Fraunhofer Institute Willie Peijnenburg, RIVM Juliane Hollender, EAWAG Patrick Roose, OSPAR Martin Keller, BfG Eva Brostrom-Lunden, IVL Anja Derksen, AD Eco advice Hélène Budzinski, Patrick Mazellier, University of Bordeaux Laurence Amalric, BRGM David Schwesig, IWW Vera Ocenaskova, TGM James Franklin, PlasticsEurope Armelle Hebert, VEOLIA Environment