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Nicola Chirico, Raquel N. Carvalho, Lidia Ceriani and Teresa Lettieri
Modelling-based strategy for the
Prioritisation Exercise under the Water
Framework Directive
2 0 1 5
Report EUR xxxxx xx
2
European Commission
Directorate General Joint Research Centre
Institute for Environment and Sustainability
H01-Water Resources Unit
Contact information
Teresa Lettieri
Address: Joint Research Centre, Via E. Fermi, 2749 - TP 121 - 21027 Ispra (Varese), Italy E-mail: [email protected]
Tel.: +39 0332 789868
https://ec.europa.eu/jrc
Legal Notice
This publication is a Science and Policy Report by the Joint Research Centre, the European Commission’s in-house science service.
It aims to provide evidence-based scientific support to the European policy-making process. The scientific output expressed does
not imply a policy position of the European Commission. Neither the European Commission nor any person acting on behalf of the
Commission is responsible for the use which might be made of this publication.
All images © European Union 2015, except: xxx (photo credits list)
JRCxxxxx
EUR xxxxx xx
ISBN xxx-xx-xx-xxxxx-x (print)
ISBN xxx-xx-xx-xxxxx-x (PDF)
ISSN xxxx-xxxx (print)
ISSN xxxx-xxxx (online)
doi:xx.xxxx/xxxxx
Luxembourg: Publications Office of the European Union, 2015
© European Union, 2015
Reproduction is authorised provided the source is acknowledged.
Printed in xxx (country name)
Abstract
The Water Framework Directive 2000/60/EC (WFD) aims to protect the aquatic environment at European level by achieving the good chemical
and ecological status of all water bodies. In order to reach the good chemical status of their waterbodies, Member states should monitor the
Priority Substances listed in Annex 10 of the WFD and they should ensure that the concentrations of these substances or groups of substances
in the aquatic environment do not exceed the related Environmental Quality Standards, set to protect human health and the environment
(Directive 2008/105/EC amended by Directive 2013/39/EU). Priority substances that are persistent, toxic and liable to bioaccumulate or which
give rise to a similar level of concern are identified as Priority Hazardous Substances. Under Article 16 (4) of the WFD, later amended by
Directive 2013/39/EU, the Commission is required to review the list of substances designated as Priority Substances and Priority Hazardous
Substances every six years. The ongoing prioritisation process is coordinated by JRC in collaboration with DG ENV and the expert sub-group of
the Working group chemicals. The process includes two approaches, the monitoring and modelling based exercises. The first has been
developed considering the available monitoring data and criteria for selection of substances undergoing this exercise. The latter has been
conceived for those substances for which either monitoring data are insufficient or completely missing. This report is focused on the
modelling-based exercise to explain the screening phase process and the models used to derive the Predicted Environmental Concentration
(PEC) required to determine the risk assessment based on the ratio between the PEC and Predicted No Effect Concentration (PNEC).
3
Table of contents 1
1 Abbreviations .............................................................................................................................. 4 2
2 Background .................................................................................................................................. 6 3
3 Introduction ................................................................................................................................. 6 4
4 Initial list ....................................................................................................................................... 7 5
5 The Modelling-based exercise ............................................................................................. 12 6
5.1 Data collection for both the screening and the risk assessment phase ................................................ 12 7
5.2 The screening phase ........................................................................................................................... 12 8
5.2.1 Exposure score .............................................................................................................................. 13 9
5.2.2 Hazard score ................................................................................................................................. 15 10
5.2.3 The Scoring system ....................................................................................................................... 21 11
5.3 The Risk Assessment Phase ................................................................................................................ 22 12
5.3.1 Introduction .................................................................................................................................. 22 13
5.3.2 PEC for freshwater ........................................................................................................................ 24 14
5.3.3 PEC for sediment for substances passing the trigger value Log Koc and Log Kow 3 ..................... 27 15
5.3.4 PEC for biota ................................................................................................................................. 28 16
5.4 Hazard assessment – estimation of PNEC values ................................................................................ 29 17
5.4.1 PNEC derivation ............................................................................................................................ 29 18
6 Final Ranking ............................................................................................................................. 29 19
7 Final remarks ............................................................................................................................ 30 20
8 Acknowledgements ................................................................................................................. 30 21
9 References .................................................................................................................................. 31 22
23
24
4
1 Abbreviations 25
ADI Acceptable Daily Intake 26
BCF Bioaccumulation Factor 27
BMF Biomagnification Factor 28
CIS Common Implementation Strategy 29
CLP Classification, Labelling and Packaging 30
CMR Carcinogenic, Mutagenic, toxic for Reproduction 31
CoRAP Community Rolling Action Plan 32
CRED Criteria for Reporting and Evaluating ecotoxicity Data 33
DB Data Base 34
DG EN Directorate-General for Environment 35
DNEL Derived No Effect Level 36
DSD Dangerous Substance Regulation 37
dw Drinking Water 38
ECETOC European Centre for Ecotoxicology and Toxicology of Chemical 39
ECHA European Chemical Agency 40
ECOSTAT Expert group for Ecological Status of water quality 41
EC10 Effect Concentration for 10% of the individuals in a toxicity test 42
ED Endocrine Disruptor 43
EFSA European Food Safety Authority 44
EMA European Medicines Agency 45
EMEA Former EMA acronym 46
EPA Environmental Protection Agency 47
ERC Environmental Release Category 48
ESVAC European Surveillance of Veterinary Antimicrobial Consumption 49
EQS Environmental Quality Standard 50
ESIS European chemical Substances Information System 51
ETUC European Trade Union Confederation 52
EqP Equilibrium partitioning method 53
FOCUS FOrum for the Co-ordination of pesticide fate models and their USe 54
fw ` Freshwater 55
hh Human Health 56
Koc Organic carbon adsorption coefficient 57
IARC International Agency for Research on Cancer 58
INERIS Institut National de l'Environnement Industriel et des Risques 59
IUCLID International Uniform Chemical Information Database 60
JDS2 Second Joint Danube Survey 61
LC50 Lethal Concentration for 50% of the individuals in a toxicity test 62
LD50 Lethal Dose for 50% of the individuals in a toxicity test 63
5
LET Literature Evaluation Tool 64
LOD Limit Of Detection 65
LOQ Limit Of Quantification 66
MACRO Model of water flow and solute transport in field soils 67
MS Member State 68
NOAEL No-Observed Adverse Effect Level 69
NOEC No-Observed Effect Concentration 70
OECD Organisation for Economic Co-operation and Development 71
OSPAR Protection of the marine Environment of the North-East Atlantic 72
PBT Persistent, Bioaccumulative and Toxic 73
PEC Predicted Environmental Concentration 74
PNEC Predicted No Effect Concentration 75
PHS Priority Hazardous Substance 76
PPP Plant Protection Product 77
PRZM Pesticide Root Zone Model 78
PS Priority Substance 79
RBSP River Basin Specific Pollutants 80
SPIN Substances in Preparations in Nordic Countries 81
REACH Registration, Authorisation and Restriction of Chemicals 82
RIWA Association of River Water Supply Companies 83
RIVM National Institute for Public Health and the Environment (NL) 84
RA Risk Assessment 85
RQ Risk Quotient (PEC/PNEC) 86
sec pois Secondary poisoning 87
sed Sediment 88
spERC Specific Environmental Release Category 89
STOT RE Specific Target Organ Toxicity Repeated Exposure 90
SVHC Substances of Very High Concern 91
SWASH Surface WAter Scenarios Help 92
TDI Tolerable Daily Intake 93
TNECS Technical Committee for New and Existing Substances 94
TG n. 27 Reference no. 18 95
TOXSWA TOXic substances in Surface WAters 96
TRA Targeted Risk Assessment 97
UBA Umwelt Bundesamt (Federal Environment Agency of Germany) 98
vB Very Bioaccumulative 99
vP Very Persistent 100
WFD Water Framework Directive 101
102
103
6
2 Background 104
The Water Framework Directive 2000/60/EC (WFD) has established a strategy for water 105
protection that included specific measures for pollution control to achieve good ecological and 106
chemical status at European level. Good chemical status has been defined in terms of 107
compliance with European environmental quality standards (EQS) for substances of concern, to 108
make sure that the concentrations found in the environment are below a safety limit, not 109
causing any harmful effects to or via the aquatic environment. Annex I of the Directive 110
2013/39/EU [2] lists forty-five PS and Priority Hazardous Substances (PHS), which have been 111
selected amongst those which present a significant risk to or via the aquatic environment. 112
Under Article 16 (4) of the WFD, later amended by Directive 2013/39/EU, the Commission is 113
required to review the list of substances designated as Priority Substances and Priority 114
Hazardous Substances every six years. Currently, the adopted list of PS is under review with the 115
aim of identifying new substances for priority action at Union level, setting and revising EQS for 116
those newly identified substances, and for some existing substances, respectively. 117
118
3 Introduction 119
The scientific and technical methodology for the current review has been developed by the JRC 120
in consultation with DG ENV and the sub-group of experts for the review (or SG-R), sub-group of 121
the Working Group Chemicals. Two main steps characterise the present prioritisation exercise 122
which as the last time includes both the monitoring and modelling based exercises [3]. First, the 123
assembling of an initial list of substances which could potentially be harmful to the 124
environment, that was compiled using all available databases provided by institutions, 125
stakeholders and peer-reviewed papers. 126
The subsequent step consisted of splitting substances into the modelling and monitoring 127
exercises (see Figure 1, for a view of the whole process). All substances that have been 128
monitored in at least four MS were considered in the monitoring-based exercise. All the 129
remaining substances (the ones for which less than 4 MS provided monitored data) were 130
considered for the modelling based exercise, characterised by two serial processes, i.e. the 131
screening and the risk assessment phase. However, during the 3rd SG-R meeting, it was asked 132
whether the substances undergoing through the monitoring based exercise could be analysed 133
performing the screening phase process. 134
The screening phase is the process that ranks the substances using both exposure and hazard 135
scores. The exposure score is based on the tonnage and the use of a substance, while the hazard 136
score is based on both the environmental and organism toxicity. The substances with the 137
7
highest score are included into the risk assessment phase, where both PEC (Predicted 138
Environmental Concentration) and PNEC (Predicted No-Effect Concentration) are derived, and 139
the corresponding Risk Quotient (PEC/PNEC, RQ) is calculated. The RQ is an estimate of the 140
exposure at which ecosystems are likely not suffer any harm [4]. 141
This report is focused on the modelling-based exercise to explain the screening phase process 142
and the models that are used to derive the PEC required for the RQ calculation. 143
144
145
Figure 1. Outline of the modelling based exercise. The present report will be focused on the modelling 146
based exercise, which comprises a screening phase and a risk assessment phase. 147
148
149
4 Initial list 150
In accordance with Art. 16 of the WFD [1], substances shall be prioritised for action on the basis 151
of risk to or via the aquatic environment. For this purpose, an initial list of 11549 substances, 152
which could potentially pose a risk to the environment, was compiled from several databases 153
(DB), reports and peer-reviewed papers. Inputs from stakeholders, international organizations 154
were collated as well. Specific lists have been assembled for biocides, endocrine disruptors (ED), 155
marine pollutants, illicit drugs, pesticides, human and veterinary medicines, and some cosmetic 156
ingredients. 157
Table 1 details the sources used and the respective number of substances. 158
159
8
160
161
Source Description Number of substances
ECHA-SVHC [5] List of Substances of Very High Concern (SVHC) 149
ECHA-CoRAP [6] List of the substances included in the Community Rolling Action Plan (CoRAP) 2013-2015, amended with the CoRAP list 2015-2017
260
ECHA-Biocides [7] List of approved Biocidal active substances, updated 07/05/2015 82
EU Pesticides database [8]
List of substances approved, pending and not plant protection products 441
European Environment Agency [9]
State of the Environment reporting 630
ECOSTAT-RBSP [10]
Substances identified by Member States as River Basin Specific pollutants 377
ESIS-CLP [11] Substances CLP classified as H400, H410, H411, H412, H413 2196
Norman List [12] this list, identified by NORMAN, comprises the currently discussed emerging substances and emerging pollutants (latest update March 2011), such as surfactants, flame retardants, pharmaceuticals, personal care products, nanoparticles, gasoline additives and their degradation products, biocides, polar pesticides and their degradation products, and various confirmed or suspected ED compounds
913
INERIS Report from the previous review [13]
Substances of the previous Monitoring-based ranking exercise were collated as well
1014
OSPAR List of Substances of Possible Concern [14]
collection of hazardous substances which are of possible concern to the marine environment, developed by OSPAR
246
OSPAR List of Chemicals for Priority Action [15]
list of substances potentially persistent, liable to bioaccumulate and toxic 31
OECD High Production Chemicals DB [16]
list of all the High Production Volume (HPV) chemicals which have been or are being investigated in the Screening Information DataSet (SIDS) programme
1469
Endocrine disruptor’s database (EU Commission) [17]
list of substances that showed (potential) evidence for ED effects. Only chemicals that belong to Category 1 and 2 were considered
277
Substitute It Now! (SIN) List [18]
the chemicals on the SIN List have been identified by ChemSec as Substances of Very High Concern (SVHC) based on the criteria established by the EU chemicals regulation REACH
772
Second Joint Danube Survey (JDS2) [19]
list of compounds identified in the surface water of the Danube River and its tributaries during the second monitoring survey along the Danube river
271
Scoping Prioritisation Report (2014) [20]
it describes a procedure proposal for the identification and prioritisation of PS built upon the outcome of the previous review of PS. Substances from table 4.2 of the report were included. These substances ranked high in either the monitoring- or the modelling-based exercises of the last review of PS, but were not short-listed for prioritization
81
TCNES’ PBT List [21]
list of substances whose PBT profile has been investigated by the Technical Committee for New and Existing Substances (TCNES) group
117
First and Second Priority List of Environment Canada [22]
list of substances that should be assessed on a priority basis to determine whether they pose a significant risk to the health of Canadians or to the environment
48
European Trade Union Confederation
list of the most urgent Substances of Very High Concern for inclusion in the Candidate List and, eventually, in the Annex XIV (the Authorisation List)
711
9
(ETUC) List [23]
US EPA Priority Chemicals list [24]
list of PS identified by the Environmental Protection Agency (EPA). The American National Waste Minimization Program focuses efforts on reducing these Priority Chemicals found in their nation's products and wastes by finding ways to eliminate or substantially reduce the use of PS in production
18
Vewin-RIWA [25] Communication from Dutch and Belgian drinking water operators on substances which breach drinking water standards or the target values for rivers in Europe.
26
Environmentally classified pharmaceuticals 2014, Stockholm County Council [26]
list of pharmaceuticals assessed by the Stockholm County Council 37
EurEau-Pharma 2014 [27]
list of pharmaceuticals of concern to drinking water 24
MistraPharma DB [28]
the MistraPharma DB, also called WikiPharma DB, contains publicly available ecotoxicity data for pharmaceutical substances, focusing on human pharmaceuticals available on the Swedish market
159
Screening program 2013 - New bisphenols, organic peroxides, fluorinated siloxanes, or-ganic UV filters and selected PBT substances [29]
the occurrence and environmental risk of a number of new bisphenols, organic peroxides, fluorinated siloxanes, organic UV filters and selected PBT substances were reported for wastewater effluents and leacha-tes, as well as sediments and biota from Oslofjord and Lake Mjøsa
38
Wikipedia Sunscreen ingredients’ List [30]
list of FDA’s approved active ingredients in sunscreens 28
JRC-IES marine pollutants [31]
Marine pollutants from literature collection 131
Von der Ohe et al. 2011 [32]
risk assessment of 500 organic substances based on observations in the four European river basins of the Elbe, Scheldt, Danube and Llobregat.
499
Lopez-Roldan et al. 2013 [33]
development of several indicators based on toxicity (PNEC) and on legislation levels (EQS) for river aquatic ecosystems assessment for screening potential chemical stressors.
6
Pal et al. 2013 [34]
review of the occurrence and concentration levels of illicit drugs and their metabolites in different environmental compartments (e.g. wastewater, surface waters, groundwater, drinking water, and ambient air) and their potential impact on the ecosystem.
13
Kools et al. 2008 [35]
environmental risk-based ranking of veterinary medicinal products. Only substances with risk indices higher than 5 for the compartment water and aquatic organisms have been included in the initial list
77
Grung et al. 2008 [36]
environmental risk assessment of eleven pharmaceuticals was performed following the guidelines from the European Medicines Evaluation Agency (EMEA).
6
Bottoni et al. 2010 [37]
review article of the relevance of pharmaceuticals, for human and veterinary use as well as of their biologically active transformation products, as environmental micropollutants.
184
Roos et al. 2012 [38]
comparison of similarities and differences in overall ranking results of 582 Active Pharmaceutical Ingredient (APIs) from nine previously proposed prioritisation schemes, both risk and hazard-based.
47
Iatrou et al. 2014 [39]
estimation of the potential environmental risks associated with human consumption of antimicrobials were estimated in Greece.
8
Kostich & Lazorchak 2007 [40]
estimation of risks associated with exposure to human prescription pharmaceutical residues in wastewater from marketing and pharmacological data
4
Boxall et al. 2003 [41]
a two-stage prioritisation scheme was developed and applied to veterinary medicines in use in the UK.
52
Capleton et al. it proposes a method for prioritising veterinary medicine APIs according 34
10
2006 [42] to estimates of their potential for indirect human exposure via the environment and their toxicity profile, and demonstrates its feasibility using an initial set of 83 veterinary medicine APIs approved for use in the UK.
Zuccato et al. 2000 [43]
list of drugs thought to be putative priority pollutants according to selected criteria. Most drugs were measurable in drinking or river waters and sediments in Lombardy (Italy), suggesting that pharmaceutical products are widespread contaminants, with possible implications for human health and the environment.
16
Sarmah et al. 2006 [44]
review of the latest information available in the literature on the use, sales, exposure pathways, environmental occurrence, fate and effects of veterinary antibiotics (especially, tylosin, tetracycline, sulfonamides and, to a lesser extent, bacitracin) in animal agriculture.
14
Dong et al. 2013 [45]
paper on a prioritization approach on 200 most-prescribed drugs in the US (2009). The approach is based on the number of prescriptions and toxicity information, accounting for metabolism and wastewater treatment removal.
43
162
Table 1. List of data sources for compiling the initial list of substances to be reviewed in the current 163
prioritisation exercise 164
165
Congeners of substances were considered separately for the initial list, and an eventual 166
grouping of substances was considered only at a later stage. Mixtures were not included, since 167
the risk assessment process for these category is not yet finalised and clear. 168
In this way, the starting number of 11549 substances was reduced to 6525 whose 573 169
substances went through the monitoring-based exercise, and the remaining 5952 through the 170
modelling-based exercise. 171
A summary of all the sources and the related number of substances is illustrated in Figure 2. 172
173
11
174
175
Figure 2. Summary of the sources of data used for the substances’ collection, with the respective 176
logarithmic number of substances considered. 177
178
12
5 The Modelling-based exercise 179
5.1 Data collection for both the screening and the risk assessment phase 180
The exposure and toxicological data were retrieved by several sources required both for the 181
screening phase and the risk assessment phase. Several web-sites and databases were consulted 182
- ECHA portal, EFSA, RIVM, EMA, IARC, European Pesticides database, Footprint Pesticides 183
Properties database, EPA, IUCLID, Endocrine Disruptors Database. Generally, both the relevance 184
and reliability of the publications retrieved from the above sources, i.e. EFSA Conclusions, 185
REACH Dossiers, European Review Reports, IARC Monographs, European Risk Assessment 186
Reports, EPA Reports, were deemed acceptable, since it was supposed that they had been 187
previously reviewed by a competent authority. The Classification, Labelling and Packaging 188
(CLP) classification of substances, officially made by ECHA, is used for the definition of a 189
substance as carcinogenic, mutagenic, and toxic to reproduction (CMR scoring). 190
Data collected for the exposure assessment and PEC calculation comprised physical and 191
chemical properties (molecular weight, water solubility, vapour pressure, biodegradability, 192
sorption potential and bioaccumulation potential), tonnage (of use, manufacture and import) 193
and specific Environmental Release Category (spERC) codes. These codes provide indication of 194
the usages of a substance allowing then to know the percentages of dispersion in the 195
environmental compartments for the modelling tools. 196
Concerning the risk assessment phase, the collection of hazard data for the aquatic and 197
sediment compartments included acute and chronic toxicity data, typically the most sensitive 198
LC/EC50 or NOEC/EC10 endpoints. Regarding mammalian or human toxicity effects from oral 199
exposure, data were collected for repeated dose toxicity, carcinogenicity, mutagenicity and 200
repro-toxicity tests, focusing on typical endpoints such as NOAEL, DNEL, ADI and TDI values. In 201
all those cases where new literature was considered in addition to the sources listed above, 202
reliability assessment of the ecotoxicological data was done by using a literature evaluation tool 203
(LET) [46], based on the Criteria for Reporting and Evaluating ecotoxicity Data (CRED) check 204
list [47] and further relevant publications were searched for. 205
206
207
5.2 The screening phase 208
The number of substances (5952) that are listed for the modelling exercise needs to be ranked 209
to select the ones of most concern. To reach this goal, every substance is categorised according 210
to its dangerousness (hazard score) and the quantity that is expected to be found in the 211
environment (exposure score). These scores are used as the indexes of a matrix that combines 212
13
the hazard with the exposure scores, such matrix gives the final risk score of a substance as a 213
result (details will be provided in the following paragraphs of the present report). 214
The exposure and hazard information searched for all the substances are shown in Table 2. 215
216
Exposure Amount produced (tonnage)
Use pattern
Hazard Persistency
Bioaccumulation
Toxicity
Carcinogenicity
Mutagenicity
Reproduction toxicity
Endocrine disruption potential
217
Table 2. Exposure and hazard properties collected for the screening phase. Exposure is defined by the 218
tonnage of the substance and its use pattern (that is the degree of dispersion). Hazard is defined by the 219
ecotoxicity of a substance (persistency, bioaccumulation and toxicity) and its toxicity (carcinogenicity, 220
mutagenicity, reproduction toxicity and endocrine disruption potential). 221
222
5.2.1 Exposure score 223
To determine the exposure score, both the use pattern and the total tonnage of a substance are 224
needed, the approach is the same used in the previous prioritisation exercise [48]. 225
The use pattern is associated with the degree of dispersion of a substance and a corresponding 226
use index is associated as shown in Table 3. 227
228
14
229
Use pattern Use index
Used in the environment 1
Wide dispersive use (diffuse sources
and substances in wastewater)
0.75
Non-dispersive use (industrial,
controlled point sources)
0.5
Not known 0.25
Controlled system (isolated
intermediate)
0.1
230
Table 3. Use pattern and use index association. The use pattern corresponds to the degree of dispersion of 231
a substance that is here associated to a numerical value (use index). 232
233
Where available, the use pattern of the substances is taken from the worst case ERC 234
(Environmental Release Category) code associated with the substance, otherwise the use 235
pattern is assessed from any additional available sources (e.g. from literature), while in other 236
case is straightforward (e.g. PPPs are always expected to be used in the environment). 237
The exposure score is associated to the use assessment (that is the expected tonnage of a 238
substance found in the environment), split (distributed) in five value ranges, as shown on Table 239
4. Each exposure score is associated to the corresponding range of use assessment. The use 240
assessment is calculated multiplying the tonnage of a substance by the use index. 241
242
243
Use assessment (tons) Exposure score
0–1 0
1–10 1
10–100 2
100–1'000 3
>1'000 4
244
Table 4. Use assessment and corresponding exposure score. The exposure score is obtained looking at the 245
corresponding use assessment range (that is the tonnage of the substance expected to be found in the 246
environment). 247
248
15
Tonnage values for Europe have been collected from several sources. Under a confidentiality 249
agreement with the European Chemicals Agency, the JRC can retrieve the information from the 250
submitted dossiers under the REACH regulation. Additionally, the Substances in Products in the 251
Nordic Countries (SPIN) database (countries are: Norway, Sweden, Denmark and Finland) has 252
been examined. To extrapolate an European tonnage values, the population statistics are used. 253
Data on pharmaceuticals consumption are available for six MS, France (Besse et al, 2008 [49]), 254
Greece (Iatrou et al, 2014 [39]), Germany (UBA report [50]), Portugal, Denmark and Latvia (the 255
agency of PT, DK and LV provided directly to JRC a list of pharmaceuticals sales/consumption). 256
These data are then used to extrapolate the total tonnage for Europe, based on population 257
number (human pharmaceuticals) or animal production (veterinary pharmaceuticals). 258
For antimicrobial substances used as veterinary pharmaceuticals the data have been retrieved 259
from the EMEA ESVAC reports [51-53] and used as main source of information. Since these data 260
reports only class of pharmaceuticals, the corresponding tonnage is applied to every single 261
pharmaceutical belonging to each class as a worst case assumption. 262
In all other cases, if it is not possible to extrapolate the tonnage due to the lack of data, the 263
substance would get a final exposure score of “0”. 264
265
5.2.2 Hazard score 266
A substance is evaluated considering the persistence, bioaccumulation and toxicity (clustered as 267
PBT), its carcinogenicity, mutagenicity and reproductive toxicity (clustered as CMR) and 268
endocrine disruptor potential (classified as ED). For the latter classification, a careful attention 269
should be devoted since at moment there is not yet a real and official classification as endocrine 270
disruptor. All these components are scored separately (i.e. P, B, T, C, M R, ED) and then summed 271
up to obtain the final hazard score. Sources of hazard data are listed in section 5.1, However 272
ECHA for industrial and inorganic chemicals, and EFSA for plant protection products, have been 273
the main sources. 274
In general, for each substance, more than one value/evaluation can be found for every 275
component of the assessment. In this case, after having assessed the reliability of the collated 276
data, the most hazardous value is chosen as a precautionary approach. 277
The criteria used to decide whether a substance has to be regarded as PBT or vPvB are provided 278
in the ECHA guidance for the PBT assessment Chapter R.11 [54]. For the purposes of hazard 279
assessment in the screening phase, whenever the respective P, or B, or T criteria are fulfilled, a 280
score of 1 was assigned to each property, respectively. If no data is available, a score of 0.1 is 281
assigned. The scoring system is summarized in Table 5. 282
283
16
P score B score T score Meaning
1 1 1 yes
0 0 0 no
0.1 0.1 0.1 no data available
284
Table 5. P, B and T scoring system adopted. Persistence (P), bioaccumulatation (B) and toxicity (T) in the 285
environment are criteria that in this exercise are either fulfilled (yes, score 1) or not (no, score 0). When 286
there is no data available a score of 0.1 is assigned as default. Individual scores are summed in the hazard 287
score. 288
289
Following the aforementioned table, a substance classified as PBT will be score 3. Additionally, 290
substances that are very persistent and significantly bioaccumulative in the food chain (vPvB), 291
will also score 3, in order to account for the higher hazard they likely pose. The PBT and vPvB 292
criteria do not apply to inorganic substances, but shall apply to organo-metals. 293
PBT and vPvB assessment has been done following rules as shown in the figures 3-5. 294
In order to determine the persistence of a compound the ECHA guidance [54] has been followed. 295
The first run has been followed for PBT and vPvB criteria, according to section 1 of Annex III to 296
REACH. If not successful, section 3.1 has been applied and, if successful the criteria under study 297
has been reported as “indicative” (the score for the hazard assessment, anyway, does not 298
change, but “indicative” is reported for clarity). If a reliable dossier (e.g. from ECHA) reported a 299
PBT assessment its conclusions has been reported instead. 300
301
17
302
Figure 3. Rules for assessing whether a substance is Persistence (P) and/or very persistence (vP). First 303
the rules for determining if a substance is vP are checked then if not fulfilled, the ones for P are followed. 304
If none of the aforementioned rules can be met, an “indication” for the P property is evaluated. These 305
rules are extracted from the ECHA guidance for PBT assessment [54] 306
307
308
309
310
311
312
18
313
Figure 4. Rules for assessing whether a substance is Bioaccumulative (B) and/or very bioaccumulative 314
(vB). First the rules for determining if a substance is vB are checked then if not fulfilled, the ones for B are 315
followed. If none of the aforementioned rules can be met, an “indication” for the B property is evaluated. 316
These rules are extracted from the ECHA guidance for PBT assessment [54] 317
318
319
320
321
322
323
324
325
326
327
328
329
19
330
Figure 5. Rules for assessing whether a substance is Toxic (T). First the rules for determining if a 331
substance is T are checked then if not fulfilled, an “indication” for the T property is evaluated. These rules 332
are extracted from the ECHA guidance for PBT assessment [54] 333
334
335
336
337
338
Regarding the scoring system assigned to the CMR (Carcinogenicity, Mutagenicity, and 339
Reproduction Toxicity) properties, the IARC classification for carcinogenicity 340
(http://monographs.iarc.fr/ENG/Classification/), the older DSD (Dangerous Substance 341
directive) classification system and the CLP Regulation 342
(http://echa.europa.eu/en/regulations/clp) are mainly followed to classify the substance. DSD 343
classification is used (categories 1 to 3) however, to harmonise the different categories, table 6 344
shows the correlation values. Table 7 summarise the scores for each property. 345
346
20
347
Directive/Regulation DSD CLP IARC
Category 1 1a 1
2 1b 2a
3 2 2b
348
Table 6. Equivalence among classification systems of the different Regulations/directives, i.e. DSD, CLP, 349
IARC. Cat. 1 – known human carcinogen/mutagen/reproductive toxicant; Cat. 2 – presumed human 350
carcinogen/mutagen/reproductive toxicant; Cat. 3 – suspected human carcinogen/mutagen/reproductive 351
toxicant. 352
353
354
355
C score C MEANING M score M MEANING R score R MEANING
1 1:CAT. 1 1 1:CAT. 1 1 1:CAT. 1
0.75 0.75: CAT.2 0.75 0.75: CAT.2 0.75 0.75: CAT.2
0.5 0.5:CAT. 3 0.5 0.5:CAT. 3 0.5 0.5:CAT. 3
0.25 0.25: UNDER EXAMINATION/EXAMINED AND INSUFF INFO/NOT EXAMINED
0.25 0.25: UNDER EXAMINATION/EXAMINED AND INSUFF INFO/NOT EXAMINED
0.25 0.25: UNDER EXAMINATION/EXAMINED AND INSUFF INFO/NOT EXAMINED
0 0: EXAMINED AND NOT CLASSIFIED
0 0: EXAMINED AND NOT CLASSIFIED
0 0: EXAMINED AND NOT CLASSIFIED
356
Table 7. Scoring system used for the classification of substances according to the CMR properties (C 357
means carcinogenic, M means mutagenic and R means toxic for reproduction). For each property (CMR) a 358
score is associated to a DSD category (see Table 6 and the corresponding caption for more details). The 359
remaining scores are: 0 when the property is not being fulfilled or 0.25 (default value) when the 360
substance is under study or not sufficient data is available to assess the property. 361
362
Concerning pharmaceuticals, even though they are expected not being CMR (at least in human), 363
they are known to be highly biologically active. Since their impact in biota cannot be excluded in 364
principle, the default value (0.25: UNDER EXAMINATION/EXAMINED AND INSUFF INFO/NOT 365
EXAMINED) has been assigned as a precautionary approach. 366
Finally, endocrine disrupting (ED) properties are investigated as well, although this information 367
is often missing. The corresponding scoring system is shown in Table 8. It is here recalled that 368
no official definition of endocrine disruptors have been so far provided, thus choosing the score 369
of a substance using Table 8 has an inherent uncertainty. 370
21
371
ED ED MEANING
1 1: PROVEN ED EFFECTS
0.5 0.5: SUSPECT ED EFFECTS
0.25 0.25: NOT EXAMINED
0 0: EXAMINED AND NOT CLASSIFIED AS ED
372
Table 8. Scoring system used for the classification of possible endocrine disruptor substances [55]. 373
374
Data on ED are mainly retrieved from the EDS database and other sources, e.g. literature. This 375
information is evaluated case by case ad a score is associated. 376
Once obtained, the final hazard score is given by the sum of the PBT, CMR and ED scores so far 377
detailed. 378
379
5.2.3 The Scoring system 380
Once the hazard score and the exposure score are obtained their values have to be used in order 381
to select an appropriate risk score. In the previous prioritisation exercise a matrix [48] was used 382
for this purpose as reported in Table 9. 383
384
385
386
Table 9. Risk scores matrix used in the previous prioritization exercise. 387
388
In order to obtain the risk score of a substance, both the hazard and the exposure scores are 389
used to select the respective risk value from the matrix. Lower is the risk score obtained from 390
the matrix, higher is the concern about the substance. Because of the range of the hazard 391
assessment score from 0 to 7, the above matrix has been rescaled in the present exercise. In this 392
way, 5 classes of hazard score range are generated, as shown in the Table 10. 393
394
Exposure assessment score
22
Ha
zard
ass
ess
me
nt
sco
re
4 3 2 1 0
Class 4 (5.6 to <= 7.0) 1 1 2 3 5
Class 3 (4.2 to < 5.6) 1 2 2 3 5
Class 2 (2.8 to < 4.2) 2 2 3 4 5
Class 1 (1.4 to < 2.8) 3 3 4 4 5
Class 0 (0.0 to < 1.4) 5 5 5 5 5
395
Table 10. Rescaled risk scores matrix using ranges of hazard scores. Red numbers are for the molecules 396
of the highest concern, which will be thus surely selected in this exercise. 397
398
Substances with the lowest score in the matrix will be selected for the RA phase of the 399
modelling-based exercise upon discussions with the sub-expert group for the prioritisation 400
exercise. 401
402
5.3 The Risk Assessment Phase 403
5.3.1 Introduction 404
Modelling tools are used to calculate the predicted environmental concentrations (PEC). In a 405
broad sense, they are based on mathematical methodologies which simulate the environmental 406
scenario where a substance is supposed to be applied. Different classes of substances are 407
usually simulated by different tools because they are differently expected to be released into 408
environment. For example, a pesticide requires a scenario which is different comparing with a 409
human pharmaceutical, since the first one is directly applied to the environment, while the 410
second one is expected to be released in the sewage system. 411
For substances that are expected to be released directly in the environment (plant protection 412
products and veterinary pharmaceuticals in the present exercise), the FOCUS surface water 413
scenario tools have been chosen. Basically, these tools simulate the fate of substances upon 414
virtual scenarios based on real data. 415
The FOCUS tools (FOCUS stands for FOrum for the Co-ordination of pesticide fate models and their 416
USe) allow calculations for four levels of a tiered approach, spanning from level 1 -the simplest 417
that requires minimum input data, giving the highest PECs because is set as the worst case 418
scenario - to level 4, which is the most refined one. In this exercise, level 3 has been selected as 419
the best compromise between required input data and accuracy of the prediction. Ten 420
representative EU scenarios, with their related hydrology, soil type and weather conditions, are 421
simulated. For the chosen scenario(s), the crop type, and the pattern of application of a 422
23
substance are crucial, because they both have an impact on the substance fate. FOCUS steps do 423
not require the tonnage of the applied substance. 424
Due to the likely entry route of veterinary pharmaceuticals into environment, i.e. by direct 425
release to the soil, or as manure application, it is possible to estimate the application rate of 426
these substances, and therefore to also carry out PEC calculations with the FOCUS tools - Step 3. 427
For the inorganic compounds, industrial substances and biocides, the ECETOC Targeted Risk 428
Assessment (TRA) tool, developed by the ECETOC organisation, has been chosen for PEC 429
calculations. The simulated scenarios are based on default environmental release codes (ERC), 430
which were developed by ECHA. The ERCs are industrial and consumers use descriptors which 431
set specific substance release percentages into the environmental compartments (air, water and 432
soil). However, in the present exercise, specific ERC (spERC) codes are used as a refinement of 433
the ERC-based emission estimation. In this way, more realistic default values of the fractions 434
released to water, air, and soil are considered. The main issue of using ECETOC is represented 435
by the need of tonnages as input data. 436
The last class of substances considered are human pharmaceuticals. In this case, the related 437
exposure scenario consists of substances that are released in the sewage, and thus ending in the 438
wastewater treatment plant. For the PEC calculation of human pharmaceuticals a simple 439
formula, taken from the publication of Besse et al. [49], is applied. 440
The following Table 11 details the tools used in this exercise for the aforementioned class of 441
substances. 442
443
Class of substances PEC calculation method Compartment involved
Plant Protection Products (PPPs) FOCUS Step 3 Water, Sediment
Biocides ECETOC – Tier 2 Water, Sediment
Generic industrial uses ECETOC – Tier 2 Water, Sediment
Inorganic compounds ECETOC – Tier 2 Water, Sediment
Veterinary pharmaceuticals FOCUS Step 3 Water, Sediment
Human pharmaceuticals Simplified EMA equation Water
444
Table 11. Methods used for calculating PEC values of the different classes of substances. FOCUS is a set of 445
tools and scenarios that simulates the fate of substances released in the environment (FOCUS is tailored 446
for plant protection products, but can also be adapted for veterinary pharmaceuticals). ECETOC Tier 2, 447
available as a set of Excel files, is a set of models that simulate the fate of substances and is tailored for 448
industrial/indoor use of substances. 449
450
24
5.3.2 PEC for freshwater 451
5.3.2.1 Plant protection products 452
FOCUS Step 3 has been selected for the PEC calculation of plant protection products (PPP). The 453
exposure assessment of PPPs is performed according to the Generic guidance for FOCUS surface 454
water Scenarios - Version 1.4 (May 2015), available online at 455
http://esdac.jrc.ec.europa.eu/projects/surface-water. A tiered approach is used to assess the 456
exposure assessment of PPPs in surface water, and the guidance document [56] details how to 457
choose the appropriate application windows, crop interception factors, degradation rates and 458
coefficient of distribution Koc of the substance. The FOCUS SWASH shell (Step 3), which handles 459
the input data and the requested tools, is adopted for estimating concentrations of PPPs in 460
ditches, ponds and streams based on ten different European scenarios. The SWASH shell 461
coordinates models which simulate runoff (R scenarios) and erosion (PRZM), leaching to field 462
drains (D scenarios) (MACRO), spray drift (internal in SWASH) and finally aquatic fate in 463
ditches, ponds and streams (TOXSWA). These simulations provide detailed assessments of 464
potential aquatic concentrations in a range of water body types for up to ten separate 465
geographic and climatic settings. 466
Once physical-chemical parameters of the substances to be assessed are provided to SWASH, 10 467
EU representative soil-climate scenarios are available for simulations and, for each scenario, a 468
set of representative crops can be selected. Location of scenarios are showed on Figure 6. In 469
order to obtain reasonable PECs using FOCUS, crops and typical pesticide application rates are 470
of pivotal importance. These data are obtained from the Good Agricultural Practice (GAP), 471
available from EFSA Conclusions or European Review reports of the active substances. The 472
highest resulting PEC value among R and D scenarios will be selected for the subsequent RQ, as 473
worst case assumption. 474
25
475
476
Figure 6. FOCUS EU scenario locations for surface water PEC calculations (D = drainage, R = runoff). 477
Details and representativeness of the scenarios can be found in the generic guidance for FOCUS surface 478
water scenario [56]. 479
5.3.2.2 Biocides, metals and generic industrial uses compounds 480
The ECETOC Targeted Risk Assessment (TRA) tool has been selected for the PEC calculation of 481
biocides, inorganics and generic industrial uses compounds. This tool handles scenarios that 482
correspond to the different ERC/spERC codes which are based on substance’s usage. Tonnages 483
and usage information are retrieved from IUCLID and the SPIN DB. This type of information is 484
crucial for the outcome of the exercise, since ECETOC needs tonnage values. For inorganic 485
compounds, modelled/measured Kp water-soil or water-sediment is used, along with biotic and 486
abiotic degradation rates set to 0. 487
For every substance more than one ERC/spERC code may be available, as it can be seen in the 488
example shown in Figure 7. For each of them, the PEC is calculated and the worst-case value is 489
selected for the calculation of the final RQ. 490
26
491
492
493
Figure 7. Example of part of ECETOC input about tonnages and sp/ERC codes. 494
495
5.3.2.3 Veterinary pharmaceuticals 496
As outlined in the EMA guidance [57], VetCalc model and the suite of models developed by the 497
FOCUS are the two main available options for refined PECfw calculations. In the current 498
prioritisation exercise, FOCUS models were selected as the tool of choice for the exposure 499
assessment of veterinary pharmaceuticals. In fact, although being specifically developed for 500
plant protection products (PPPs), FOCUS models’ predictions can also be used for veterinary 501
pharmaceuticals, with appropriate precautions and model settings (see Table 7). This is due to 502
the similarities between the field application of PPPs and the spreading of veterinary 503
pharmaceuticals (by means of manure or grazing animals) to the soil. The available scenario 504
that is deemed appropriate for the EMA setup (i.e. winter cereals) is used and the corresponding 505
PECs is calculated. 506
507
27
508
Parameter Input values considered
Crop Winter cereals
Application timing Pre-emergence application dates
Application rate (AR) Calculated from PECsoil,initial (in general, use of PECsoil calculated for intensively
reared animals, or pasture animals) by using EMA equation.
DT50 of substance Experimental value, if available. Otherwise, set to zero.
Crop uptake None
Application method Soil or granular incorporation
Wash-off factor Wash-off factor (m-1): ≥ 10-6, even if there is no wash-off.
Depth (m) Soil depth used to calculate PECsoil
509
Table 12. FOCUS model settings for exposure assessment of veterinary pharmaceuticals [57] 510
511
5.3.2.4 Human pharmaceuticals 512
For human pharmceuticals, PEC values is calculated using the following equation A [49] 513
514
PECfw= (consumption × Fexcreta) / (WWinhab × hab × dilution × 365) (A) 515
516
where WWinhab is the volume of wastewater per person per day (default value of 200 517
[L/(hab*day]), hab is the number of inhabitants, Fexcreta is the excretion factor of the active 518
substance (retrieved from the same publication), dilution is the dilution factor (default value of 519
10), consumption is the quantity (mg/year) of active ingredient consumed by the population 520
during 1 year. 521
This simplified approach can be chosen because of the relatively simple scenario when 522
modelling human pharmaceutical fate (wastewater is the most common fate because of the 523
excretion of these substances). Consumption is the most difficult value to be found because data 524
is available only for few MS (see Screening phase section for more details) and often only for a 525
limited number of substances. As a consequence the tonnage for the Europe is extrapolated for 526
the EU total population. In the previous Watch List exercise [46], the worst case PEC value 527
among those estimated for each antibiotic was selected for the risk quotient (RQ) calculation. 528
5.3.3 PEC for sediment for substances passing the trigger value Log Koc and Log Kow 3 529
For the calculation of the PECsed ECETOC results is used for inorganic compounds and generic 530
industrial substances, whenever tonnages values are available, and FOCUS Step 3 is adopted for 531
PPPs and veterinary pharmaceuticals. Lastly, both for those substance whose information is 532
lacking for the correct use of ECETOC, and for human pharmaceuticals, the sediment 533
28
equilibrium partition method (EqB) will be used for PECfw calculation, following the TG n. 27- 534
CIS WFD [58] 535
536
𝑃𝐸𝐶𝑠𝑒𝑑−𝑤𝑤 =Ksed-water
RHOsed PECfw 1000 (𝐵) 537
538
RHOsed is the bulk density of wet sediment, Ksed-water is the partition coefficient between 539
sediment and water and 1000 is the conversion factor from m3 to litre. 540
Since the final PECsed is calculated in terms of dry weight, a conversion step is required, by using 541
the following equations C and D. 542
543
𝐶𝑂𝑁𝑉𝑠𝑒𝑑 =𝑅𝐻𝑂𝑠𝑒𝑑
𝐹𝑠𝑜𝑙𝑖𝑑𝑆𝑒𝑑 𝑅𝐻𝑂𝑠𝑜𝑙𝑖𝑑 (𝐶) 544
545
𝑃𝐸𝐶𝑆𝑒𝑑 = 𝐶𝑂𝑁𝑉𝑠𝑒𝑑 𝑃𝐸𝐶𝑠𝑒𝑑−𝑤𝑤 (𝐷) 546
547
For the calculation of KSed-water, the following equation E will be used. 548
549
𝐾𝑠𝑒𝑑−𝑤𝑎𝑡𝑒𝑟 = 𝐹𝑎𝑖𝑟𝑠𝑒𝑑𝐾𝑎𝑖𝑟−𝑤𝑎𝑡𝑒𝑟 + 𝐹𝑤𝑎𝑡𝑒𝑟𝑠𝑒𝑑 + 𝐹𝑠𝑜𝑙𝑖𝑑𝑠𝑒𝑑 𝐾𝑝𝑆𝑒𝑑
1000 𝑅𝐻𝑂𝑠𝑜𝑙𝑖𝑑 (𝐸) 550
551
Default values for Fairsed, RHOsolid, Fwatersed, Fsolidsed and Focsed are taken from TG n. 27 - CIS 552
WFD [58]. The given default value for Fairsed is zero [58]. 553
554
5.3.4 PEC for biota 555
PEC for biota is calculated considering the bioaccumulation through the food chain, for fresh 556
water organisms, exemplified as BCF →aquatic organisms→BMF→fish→fish eating predators. 557
BCF is the bioconcentration factor that accounts for the concentration of the substance from 558
water to the organism while BMF is the biomagnification factor that accounts for the increasing 559
of the substance concentration in the organism through the food chain. 560
For the calculation of the PEC for biota (PECbiota) the following equation is used [59]. 561
562
𝑃𝐸𝐶𝑏𝑖𝑜𝑡𝑎 = 𝑃𝐸𝐶𝑓𝑤 𝐵𝐶𝐹 𝐵𝑀𝐹 (𝐹) 563
564
29
5.4 Hazard assessment – estimation of PNEC values 565
5.4.1 PNEC derivation 566
Substance risk assessment in the water compartment is relevant for the protection of organisms 567
inhabiting the water column. Therefore, the protection threshold concentrations PNECfw is 568
estimated for the substances that will be selected from the screening phase. 569
The PNEC value is the concentration of a substance for which it is expected no harm for the 570
environment, in our case water bodies (in this exercise only long-term PNEC, i.e. those for 571
chronic effect, are considered). 572
Whenever sufficient data are available, the probabilistic approach is carried out for the 573
derivation of the PNEC. An adequate AF is then applied to the derived HC5 (Hazardous 574
Concentration to 5 % of species), following the 5 recommendations set in the ECHA guidance 575
(Chapter R 10, 2008). 576
When there is not enough data available, the deterministic approach is used. For the calculation 577
of the PNEC, representative trophic levels have to be considered - algae, crustaceans and fishes, 578
which mimic a typical hypothetical food chain of a fresh water body. For each trophic level, the 579
highest toxicity level of a representative species is considered. For each substance, according to 580
its properties, a PNEC value for fresh water-sediment (PNECsed) (TG n. 27- CIS WFD [58] and the 581
ECHA Guidance (2008) [60]) and PNEC values for secondary poisoning in biota (PNECbiota, sec pois) 582
are calculated for all substances with a potential to bioaccumulate, following the TG n. 27 - CIS 583
WFD [58]. 584
Drinking water is a possible route of human exposure to substances in water, and the PNEC for 585
human drinking water (PNECdw, hh) have been derived for all substances, based on human 586
toxicity data. If available, WHO [61] or EU [62] drinking water standards have been used as the 587
PNECdw, hh values for that substance. When a WHO drinking water standard is not available, the 588
PNECdw, hh is calculated as detailed in the TG n. 27 - CIS WFD [58]. 589
590
591
6 Final Ranking 592
Risk quotients (RQ) will be estimated for all the relevant receptors at risk, i.e. RQfw, RQsed, 593
RQbiota,secpois , RQbiota,hh, RQdw,hh, and for the respective group of substances considered, i.e. human 594
pharmaceuticals, veterinary pharmaceuticals, biocides, inorganic compounds, generic industrial 595
uses and PPPs. Measured Environmental Concentrations (MEC) will be used as a decision-596
supporting information whether available for the selection of the most toxic substances. 597
Moreover, feedbacks from the experts of the SG-R and Working Group of Substances will also be 598
30
taken on board for the final ranking of the most hazardous compounds according to the current 599
modelling based risk assessment. 600
601
7 Final remarks 602
The approach described in this report, although validated on representative data, has to be 603
intended as a proposal since some details could change during the finalisation of the procedure, 604
when applied to the whole initial list. The number of the substances in the initial list is also 605
expected to change slightly because of possible further refinements and updates. 606
607
8 Acknowledgements 608
We are grateful for the collaboration with ECHA and EFSA, and for their support on data 609
collection. 610
Sales data on human pharmaceuticals were kindly provided by the State Agency of Medicines of 611
the Republic of Latvia, the INFARMED National Authority of Medicines and Health Products of 612
Portugal, the Federal Environment Agency of Germany, the Statens Serum Institut and the DHI 613
group of Denmark. 614
Finally, we would like to thank Helen Clayton and Stephanie Schaan for helpful discussion and 615
for the revision of the report. 616
617
618
31
9 References 619
620
[1] European Union Directive 2000/60/EC (WFD) establishing a framework for Community 621
action in the field of water policy. 622
[2] European Union Directive 2013/39/EU amending Directives 2000/60/EC and 2008/105/EC 623
as regards priority substances in the field of water policy. 624
[3] European Commission (2014). Procedures for the identification and prioritization of priority 625
substances: amended draft scoping report. 626
[4] van Leeuwen, and Germeire, 2007. Risk Assessment of Chemical: An Introduction. Second 627
Edition. Springer. 628
[5] ECHA’s SVHC list, available at http://echa.europa.eu/it/candidate-list-table (last access May 629
2014) 630
[6] CoRAP List, available at http://echa.europa.eu/documents/10162/13626/qa_corap_en.pdf 631
(last access May 2014) 632
[7] ECHA’s list of biocidal active substances, available at 633
http://echa.europa.eu/web/guest/information-on-chemicals/active-substance-suppliers (last 634
access May 2014) 635
[8] European Pesticides DB, by DG SANCO, available at 636
http://ec.europa.eu/sanco_pesticides/public/?event=homepage (last access May 2014) 637
[9] European Environment Agency: http://www.eea.europa.eu/ (last access May 2014) 638
[10] Irmer U, Rau F, Arle J, Claussen U and Mohaupt V. (2014) Ecological Environmental Quality 639
Standards of “River Basin Specific Pollutants” in Surface Waters - Update and Development 640
Analysis of a European Comparison between Member States. Technical Report for the WFD CIS 641
Working Group A Ecological Status (ECOSTAT). 642
[11] ESIS website taken over by ECHA: http://esis.jrc.ec.europa.eu/index.html (last access May 643
2014), 644
[12] NORMAN emerging list of substances, available at http://www.norman-645
network.net/?q=node/19 (last access May 2014) 646
[13] Implementation of requirements on Priority substances within the Context of the Water 647
Framework Directive, Contract N° 07010401/2008/508122/ADA/D2, Prioritisation process: 648
Monitoring-based ranking (September 2009). INERIS. 649
[14] OSPAR’S list of substances of possible concern, available at 650
http://www.ospar.org/content/content.asp?menu=00950304450000_000000_000000 (last 651
access May 2014) 652
32
[15] OSPAR’s list of chemicals for priority action, available at 653
http://www.ospar.org/content/content.asp?menu=00950304450000_000000_000000 (last 654
access May 2014) 655
[16] HPV Chemicals listed by OECD, available at http://webnet.oecd.org/hpv/ui/Search.aspx 656
(last access May 2014) 657
[17] Endocrine Disruptor substances’ DB, by EU Commission, available at 658
http://ec.europa.eu/environment/chemicals/endocrine/documents/index_en.htm (last access 659
May 2014) 660
[18] SIN list of hazardous substances, available at http://www.chemsec.org/what-we-do/sin-661
list (last access May 2014) 662
[19] Joint Danube Survey 2, Final Scientific Report. Editors: Igor Liška, Franz Wagner, Jaroslav 663
Slobodník. Published by ICPDR – International Commission for the Protection of the Danube 664
River (2008). Available at http://www.icpdr.org/main/ 665
[20] Technical report support in relation to the implementation of Priority Substances aspects 666
under the Water Framework Directive 2000/60/EC. Procedures for the identification and 667
prioritisation of Priority Substances scoping report. DG ENV, March 2014. 668
[21] List of substances screened for their PBT potential, taken from 669
http://esis.jrc.ec.europa.eu/index.html (last access May 2014), which has been taken over by 670
ECHA 671
[22] Environment Canada’s priority substances list, available at https://www.ec.gc.ca/ese-672
ees/default.asp?lang=En&n=C04CA116-1 (last access May 2014) 673
[23] ETUC’s priority list for REACH Authorisation, available at 674
http://www.etuc.org/sites/www.etuc.org/files/TUListREACH.pdf (last access May 2014) 675
[24] EPA’s priority substances list, available at 676
http://www.epa.gov/osw/hazard/wastemin/priority.htm (last access May 2014) 677
[25] Association of River Water Supply Companies, available at http://www.riwa-maas.org/ 678
(last access May 2014) 679
[26] ENVIRONMENTALLY CLASSIFIED PHARMACEUTICALS, Stockholm County Council, 2014. 680
Available at 681
http://www.sustainabilityroadmap.org/pims/pdfs/pim243_Environmental_classified_pharmac682
euticals_2014_2015_booklet.pdf (last access May 2014) 683
[27] List of pharmaceuticals of concern for drinking water, available at 684
http://www.confservizi.piemonte.it/public/Castell.pdf 685
[28] MistraPharma’s list of human pharmaceutical substances, available at 686
http://www.wikipharma.org/welcome.asp (last access May 2014) 687
33
[29] Screening Program 2013 - New bisphenols, organic peroxides, fluorinated siloxanes, 688
organic UV filters and selected PBT substances, by Norsk institutt for vannforskning (NIVA) and 689
NILU - Norsk institutt for luftforskning. Available at 690
http://www.miljodirektoratet.no/Documents/publikasjoner/M176/M176.pdf 691
[30] List of sunscreen ingredients approved by FDA, available at 692
http://en.wikipedia.org/wiki/Sunscreen (last access May 2014) 693
[31] JRC-IES marine group - personal communication 694
[32] A new risk assessment approach for the prioritization of 500 classical and emerging 695
organic microcontaminants as potential river basin specific pollutants under the European 696
Water Framework Directive. Peter Carsten von der Ohe, Valeria Dulio, Jaroslav Slobodnik, Eric 697
De Deckere, Ralph Kühne, Ralf-Uwe Ebert, Antoni Ginebreda, Ward De Cooman, Gerrit 698
Schüürmann, Werner Brack. Science of the Total Environment 409 (2011) 2064–2077. 699
[33] Ecological screening indicators of stress and risk for the Llobregatriver water. Ramon 700
López-Roldán, Irene Jubany, Vicenc Martí, Susana González, Jose Luis Cortin. Journal of 701
Hazardous Materials 263P (2013) 239– 247. 702
[34] Illicit drugs and the environment — A review. Raktim Pal, Mallavarapu Megharaj, K. Paul 703
Kirkbride, Ravi Naidu. Science of the Total Environment 463–464 (2013) 1079–1092. 704
[35] A Ranking of European Veterinary Medicines Based on Environmental Risks. Stefan AE 705
Kools, Alistair BA Boxall, Johann F Moltmann, Gareth Bryning, Jan Koschorreck, and Thomas 706
Knacker. Integrated Environmental Assessment and Management,Vol. 4, Num. 4, (2008) , 399–707
408 708
[36] Environmental assessment of Norwegian priority pharmaceuticals based on the EMEA 709
guideline. Merete Grung, Torsten Ka¨ llqvist, Solveig Sakshaug, Svetlana Skurtveit, Kevin V. 710
Thomas. Ecotoxicology and Environmental Safety 71 (2008), 328–340. 711
[37] Pharmaceuticals as priority water contaminants. P. Bottoni, S. Caroli and A. Barra 712
Caracciolo. Toxicological & Environmental Chemistry Vol. 92, No. 3, (2010), 549–565. 713
[38] Prioritising pharmaceuticals for environmental risk assessment: Towards adequate and 714
feasible first-tier selection. V. Roos, L. Gunnarsson, J. Fick, D.G.J. Larsson, C. Rudén. Science of the 715
Total Environment 421-422 (2012), 102–110. 716
[39] Consumption-based approach for predicting environmental risk in Greece due to the 717
presence of antimicrobials in domestic wastewater. Evangelia I. Iatrou & Athanasios S. 718
Stasinakis & Nikolaos S. Thomaidis. Environ Sci Pollut Res. Vol. 21(22), (2014), 12941-50 719
[40] Risks to aquatic organisms posed by human pharmaceutical use. Mitchell S. Kostich, James 720
M. Lazorchak. Science of the Total Environment 389(2008)329-339. 721
[41] Prioritisation of veterinary medicines in the UK environment. Alistair B.A. Boxall, Lindsay 722
A. Fogg, Paul Kay, Paul A. Blackwel, Emma J. Pemberton, Andy Croxford. Toxicology Letters 142 723
(2003) 207/218. 724
34
[42] Prioritising veterinary medicines according to their potential indirect human exposure and 725
toxicity profile. Alexander C. Capleton, Carol Courage, Paul Rumsby, Philip Holmes, Edward 726
Stutt, Alistair B.A. Boxall, Leonard S. Levy. Toxicology Letters 163 (2006) 213–223. 727
[43] Presence of therapeutic drugs in the environment. Ettore Zuccato, Davide Calamari, Marco 728
Natangelo, Roberto Fanelli. THE LANCET, Vol 355, May 20, 2000. 729
730
[44] A global perspective on the use, sales, exposure pathways, occurrence, fate and effects of 731
veterinary antibiotics (VAs) in the environment. Ajit K. Sarmah, Michael T. Meyer, Alistair B.A. 732
Boxall. (2006), Vol. 65(5), pp.725-59 733
[45] Prioritizing environmental risk of prescription pharmaceuticals. Zhao Dong, David B. Senn, 734
Rebecca E. Moran, James P. Shine. Regulatory Toxicology and Pharmacology 65 (2013) 60–67. 735
[46] Development of the first Watch List under the Environmental Quality Standards Directive. 736
JRC Technical Report 2015, Report EUR 27142 EN. 737
[47] Moermond CTA, Kase R, Korkaric M and Ågerstrand M. (2015) CRED: Criteria for reporting 738
and evaluating ecotoxicity data. Environ Toxicol Chem. Accepted Author Manuscript. 739
doi:10.1002/etc.3259. 740
[48] A modelling approach for the prioritization of chemicals under the water framework 741
directive. K. Dagginus, S. Gottardo, A. Mostrag-Szlichtyng, H. Wilinson, P. Whitehouse, A. Paya-742
Pérez and J.M. Zaldivar. JRC Scientific and Technical Report 2010. 743
[49] Exposure Assessment of Pharmaceuticals and Their Metabolites in the Aquatic 744
Environment: Application to the French Situation and Preliminary Prioritization. Jean-Philippe 745
Besse,1 Christine Kausch-Barreto, and Jeanne Garric. Human and Ecological Risk Assessment, 746
14: 665–695, 2008. 747
[50] Final Report Behaviour of selected human and veterinary pharmaceuticals in aquatic 748
compartments and soil. Research Report 299 67 401/01, UMWELTBUNDESAMT (UBA) , 2004. 749
[51] 750
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/10/WC500133532.p751
df (last access January 2016) 752
[52] 753
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/10/WC500152311.p754
df (last access January 2016) 755
[53] 756
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.p757
df (last access January 2016) 758
[54] Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: 759
PBT/vPvB assessment. Version 2.0. ECHA 2014. 760
35
[55] NORMAN Prioritisation frameworkemerging substances. Valeria Dulio and Peter C. von del 761
Ohe. NORMAN association, 2013. 762
[56] FOCUS Generic guidance for FOCUS surface water Scenarios - Version 1.4, available at 763
http://esdac.jrc.ec.europa.eu/public_path/projects_data/focus/sw/docs/Generic%20FOCUS_S764
WS_vc1.4.pdf (last access January 2016) 765
[57] Revised guideline of envirnomental impact assessment for veterinary medicinal products, 766
EMEA 2008. Doc. Ref. EMEA/CVMP/ERA/418282/2005-Rev.1. 767
[58] Guidance Document No. 27 - Technical Guidance For Deriving Environmental Quality 768
Standards. European Commission 2011, Technical Report - 2011 – 055. 769
[59] ECHA guidance – Guidance on information requirements and chemical safety assessment 770
(2012) Chapter R.16 771
[60] Guidance on information requirements and chemical safety assessment Chapter R.10: 772
Characterisation of dose[concentration]-response for environment. ECHA 2008. 773
[61] Guidelines for drinking-water quality - Volume 1: Recommendations (2008) World Health 774
Organization. 775
[62] COUNCIL DIRECTIVE 98/83/EC on the quality of water intended for human consumption776
777