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Emerging pollutants in the EU: 10years of NORMAN in support of environmental policies and regulations

Emerging pollutants in the EU: 10years of NORMAN in support of environmental policies and... In 2005, the European Commission funded the NORMAN project to promote a permanent network of reference labo‑ ratories and research centers, including academia, industry, standardization bodies, and NGOs. Since then, NORMAN has (i) facilitated a more rapid and wide‑ scope exchange of data on the occurrence and effects of contaminants of emerging concern (CECs), (ii) improved data quality and comparability via validation and harmonization of common sampling and measurement methods (chemical and biological), (iii) provided more transparent information and mon‑ itoring data on CECs, and (iv) established an independent and competent forum for the technical/scientific debate on issues related to emerging substances. NORMAN plays a significant role as an independent organization at the interface between science and policy, with the advantage of speaking to the European Commission and other public institutions with the “bigger voice” of more than 70 members from 20 countries. This article provides a summary of the first 10 years of the NORMAN network. It takes stock of the work done so far and outlines NORMAN’s vision for a Europe‑ wide collaboration on CECs and sustainable links from research to policy‑ making. It contains an overview of the state of play in prioritizing and monitoring emerging substances with reference to several innovative technolo‑ gies and monitoring approaches. It provides the point of view of the NORMAN network on a burning issue—the regulation of CECs—and presents the positions of various stakeholders in the field (DG ENV, EEA, ECHA, and national agencies) who participated in the NORMAN workshop in October 2016. The main messages and conclusions from the round table discussions are briefly presented. Keywords: NORMAN network, Emerging substances, Contaminants of emerging concern, Science‑ to‑ policy, Environmental monitoring chemicals that are currently not regulated (not submitted Background to a routine monitoring and/or emission control regime), This paper, triggered by the 10th anniversary of the NOR - but may be under scrutiny for future regulation. In addi- MAN Association [1] and the outcomes of the workshop tion, it is now common knowledge that the contaminants that was organized to mark this occasion, discusses the of interest are not necessarily newly developed chemi- work performed within the NORMAN network over the cals: most CECs are substances that have entered the last 10  years and the way forward to improving Europe- environment for years, even decades, but their presence wide collaboration on CECs and related policy-making. has only recently begun to be investigated. Most known It is now about a decade, since the term “contaminants CECs include industrial compounds, pharmaceuticals, of emerging concern” (CECs) became a common term for personal-care products, biocides, and plant protection products, but the list of compounds is constantly grow- *Correspondence: valeria.dulio@ineris.fr ing and this is not surprising when we consider that more INERIS, National Institute for Environment and Industrial Risks, than 100 million chemical substances are currently regis- Verneuil‑en‑Halatte, France tered in the Chemical Abstracts Service (CAS) and about Full list of author information is available at the end of the article © The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Dulio et al. Environ Sci Eur (2018) 30:5 Page 2 of 13 4000 new ones are registered every day. According to the To achieve these goals, NORMAN brings together not number of registered and pre-registered substances in only the scientific community on emerging substances REACH, 30,000–50,000 industrial chemicals are found but also the many agencies actively involved in the deci- in daily-use products [2, 3] and they are potentially ulti- sion-making on emerging substances and even private mately released into the environment. Chemicals are eve- companies. The multidisciplinary membership of NOR - rywhere, in the water we drink, in the food that we eat in MAN has proven to be a strong point as it helps to pull the homes in which we live. knowledge of emerging substances together and pushes There are increasing concerns about the combined the latest scientific findings towards policy-making. The effects of this multitude of chemicals as they enter the activities are organized in eight working groups dealing environment and the food chain, although each chemical with different CECs aspects, i.e., prioritization, effect- used in a minute quantity may be considered harmless [4, based tools, effect-directed analysis, nanomaterials, 5]. In addition, there is today a general consensus among wastewater reuse, indoor environment as well as two policy-makers that emerging substances need to be cross-working group activities on passive sampling and addressed in a systematic and coherent manner. It is also non-target screening (Fig. 1). widely accepted that there is a need for an early warn- NORMAN publishes a bulletin on CECs, with informa- ing system able to play the role of the “watchdog”. Such tion on current initiatives, results of collaborative pro- a system should anticipate the risks associated with the jects and future perspectives in the field [8]. More than dynamic change in the use of chemicals so as to prevent 30 international events [9] have been organized by NOR- the environmental impact of chemical substances before MAN since 2006 and position papers have been pub- they become “contaminants of emerging concern”. In lished on various relevant topics by NORMAN experts, other words, our ultimate objective should be to advance such as passive sampling [10], effect-directed analysis our knowledge and environmental monitoring abilities to [11], and more recently a paper with 10 recommenda- the point, where the need for the term “emerging” disap- tions [12] for the review of the Water Framework Direc- pears altogether [6]. tive (WFD) [13], developed in collaboration with the In 2004, NORMAN came into existence following a SOLUTIONS project [14]. call by the EU Commission (DG Research) to create “a The stakeholders at the 10th anniversary workshop permanent network of reference laboratories and related unanimously agreed that NORMAN has succeeded in organizations dealing with emerging environmental sub- building a strong infrastructure and developing tools to stances” [7]. Its main objectives—on which it has been connect science and policy. NORMAN has also proven working actively over the past 10  years—are to improve to be a good platform to reach consensus among experts the exchange of information on emerging substances and for harmonization of practices. to foster harmonization of protocols and improvement of Overall, NORMAN aims to play the long-term role of data quality. global early-warning platform for CECs, closely related Today, NORMAN is an independent and highly recog- to the non-toxic environment strategy [15]. nized network of reference laboratories, research centers, and related organizations for the monitoring of contami- NORMAN achievements and future perspectives nants of emerging concern. In 2006, its first full year of A first consideration when speaking about NORMAN’s operation, it was a consortium of 17 members; today, it achievements over the last 10 years is that NORMAN has is a self-sustaining, non-profit organization of more than been able to establish and operate a collaboration mecha- 70 members. nism to deal with the following crucial questions about Five pillars constitute the NORMAN objectives: emerging substances: What are the most suitable tech- niques and strategies to identify and prioritize poten- tial problematic chemicals? Do we have enough data to • Independent, transparent, and open network, work- assess the risks associated with CECs? Do the data pass ing for a sustainable environment without harmful quality criteria and are they representative enough? And substances. do we have access to all the data that are available? • Go-to organization for issues on emerging sub- stances in the environment. Prioritization of CECs • Watchdog and alarm bell for emerging environmen- The prioritization of chemical contaminants is a task of tal threats. primary importance for environmental managers and the • Bridge between science and policy-making. scientific community, for the definition of priority actions • Platform for innovative bottom–up initiatives to for pollution prevention and control, and the efficient explore new monitoring challenges. allocation of resources to address current knowledge Dulio et al. Environ Sci Eur (2018) 30:5 Page 3 of 13 gaps. Starting from the observation that, for most emerg- exploitation of raw monitoring data to support prioritiza- ing substances, it is primarily the knowledge gaps which tion exercises. This is closely connected with the second still prevent proper risk assessment and risk ranking, pillar, the EMPODAT ECOTOX module, a platform for NORMAN has developed a rational and holistic prior- systematic collection and evaluation of the relevance and itization approach (Fig.  2) which gives more systematic reliability of ecotoxicity studies which aims to become an consideration to the knowledge gaps relating to emerg- essential tool for the European community of ecotoxicol- ing substances [16, 17]. The scheme has been used by ogists for the derivation and harmonization of predicted NORMAN to provide recommendations to the European no-effect concentration (PNEC) threshold levels. NTS, Commission for the prioritization of the compounds the third pillar, includes recent workflows for the appli - on the first European Watch List [18] and has also been cation and evaluation of high-resolution mass spectrom- adopted by regulatory agencies in France [19, 20] and in etry for identification of suspects and unknowns. The Slovakia [21]. results from NTS, i.e., checking presence/absence and In the light of the experience acquired, NORMAN is semi-quantitative information about these compounds now committed to the further development of the cur- in a large number of samples by NORMAN partners in rent scheme with the extension of the original NOR- different countries, will help in the future to prioritize MAN list of substances (ca. 900 compounds) to a much the most relevant compounds for possible further evalu- larger list of several thousands of compounds. This goes ation as substances of potential regulatory concern. The along with the establishment of dynamic links with exist- collaborative NormaNEWS [25] joint activity has already ing databases (such as, for example, the US EPA Comp- successfully demonstrated the usefulness of the retro- Tox Chemistry Dashboard [22]) for a more powerful and spective screening of high-resolution mass spectrometric systematic retrieval of supporting data for prioritization data in establishing the spatial and temporal occurrences of substances, and the introduction of new indicators for of newly identified compounds of potential emerging better integration of the results from novel monitoring- concern [26]. based approaches, such as suspect and non-target screen- ing (NTS) as well as effect-based methods (EBM) in the Data collection and data management prioritization process. NORMAN fosters an integrative Reliable identification and prioritization of relevant CECs approach for the prioritization of CECs [23], which relies is strongly dependent on the quality and quantity of on three pillars: the first is EMPODAT [24], a powerful archived monitoring data. The development of databases database system which has been developed to store the such as EMPODAT and improvement of data exchange monitoring data collected by NORMAN members and have been NORMAN’s core business since the start of as a tool for use by regulators and scientists alike for the the project. A clear need was identified at the time of the prioritization of CECs. Its added value will be further launch of the NORMAN project, which was confirmed increased in the future thanks to its full integration into by the first NORMAN Databases workshop in 2011 [27], the European Information Platform for Chemical Moni- where experts concluded that, in spite of the numerous toring (IPCHEM) [4], which will improve systematic chemical monitoring activities carried out in the EU and WG1 WG2 WG3 Prioritisation of emerging substances Bioassays and biomarkers in water Effect-directed analysis for hazardous quality monitoring pollutants identification Cross-Working Group Activity: Passive sampling(PS) Passive sampling for emerging contaminants Cross-Working Group Activity Non-target Screening (NTS) Non-target screening techniques for environmental monitoring WG4 WG5 WG6 Nano-and micro scale particulate Wastewater reuse and Contaminants of Emerging substances in the indoor contaminants Emerging Concern environment Fig. 1 Overview of the NORMAN Working Groups Dulio et al. Environ Sci Eur (2018) 30:5 Page 4 of 13 worldwide and the significant amounts of data generated collaborating in one DSFP and sharing its ‘big data’ has by the scientific community within research projects, been recently tested among a core group of NORMAN, environmental monitoring data were not systematically with data sets obtained within the Joint Danube Survey collected at the EU level [28]. EMPODAT [24] is today 3 (surface water samples) [31] and the EU/UNDP EMB- the largest database on emerging substances worldwide, LAS project (marine water, sediment, and biota sam- with about ten million data records for more than 500 ples) [32]. Further improvement of functionalities of the emerging substances. The interest and contribution of DSFP (upload of raw mass chromatograms, visualisation the network partners have enabled the database system of data, batch mode processing, use of MS–MS informa- to constantly grow, and new modules for accommoda- tion, etc.), the extension of its functionalities for archiv- tion of passive sampling, indoor environment, bioassays ing and processing of gas chromatography–HR-MS data monitoring, antibiotic-resistant bacteria (ARBs), and and testing of various options for archiving and process- antibiotic-resistant genes (ARGs) data are now under ing of ‘big data’ at the wider European scale are planned development. Besides that, the ECOTOX module already for 2018 and beyond. contains predicted and experimental PNECs for more than 13,000 substances and its sustainable growth is one Methods’ harmonization and validation of the priority tasks of the NORMAN network. The trend The NORMAN community is recognized as particularly is clearly towards encouraging data sharing, improving strong in analytical matters and the studies organized access and use of available data along with improvement by the network represent a crucial step for the scientific of their quality. The value of the NORMAN platform is community and for environmental agencies in the prepa- fully recognized by the European Commission, with ration of the ground for validation and harmonization of which NORMAN has recently started a close collabora- innovative sampling and monitoring tools before their tion to achieve permanent integration of EMPODAT in possible future implementation in regulations. IPCHEM [4]. As regards improvement of data quality, one major achievement of NORMAN has been the development Evolution towards “big data” management: from hundreds of a common framework for validation of chemical and to tens of thousands of candidate substances biological monitoring methods—a protocol which is We are increasingly aware that there is a need to evolve now adopted as a Technical Specification (TS) of the towards a system able to deal with several thousands European Committee for Standardization (CEN) (CEN of compounds which may enter the environment. TS 16800:2015) [33, 34]. In other words, NORMAN has NORMAN is already working to replace the original defined a clear list of “rules” that the laboratories need “NORMAN list of emerging substances” of about 900 to observe to be able to state that their method is “vali- compounds with a much larger list of substances. The dated”—and it is well known how method validation is NORMAN Suspect List Exchange database (SusDat) crucial, especially when it comes to the measurement of database [29] has recently been launched and already substances which laboratories are not familiar with, with includes more than 40,000 compounds as a common clear consequences for the quality and reliability of the effort of European and North American researchers. All results produced. Besides that, NORMAN has organized suspect lists currently available in SusDat can be viewed interlaboratory studies on substances of priority inter- at the NORMAN website and are being progressively est in research [35, 36] and has more recently extended integrated into the US EPA CompTox Chemistry Dash- these inter-comparison activities to passive sampling board [22]. This large list will become the new “universe” [37], bioassays [38], and non-target screening methods of compounds for prioritization, and the NORMAN List [31]. will be defined as the list of top priority compounds in each prioritization action category. New tools to improve future monitoring and regulation Non-target screening analysis, combined with the inte- of CECs gration of high-performance computing, becomes “ready Non‑target screening to go” for environmental applications [30] and moves In line with the strong expertise of the NORMAN net- traditional exposure analysis to ‘big data’: the NORMAN work in the field of high-resolution mass spectrometry ‘Digital Sample Freezing Platform (DSFP)’ is currently techniques and NTS approaches, several activities have under development to host in a harmonized format full- been launched over the past years and continue to be scan high-resolution mass spectrometry (HR-MS) data, promoted to improve harmonization of liquid chroma- allowing for high-throughput processing (including ret- tography coupled to high-resolution tandem mass spec- rospective analysis) of any environmental sample for a trometry [LC–HR-MS(MS)] and gas chromatography wide range (thousands) of pollutants. The concept of coupled to mass spectrometry (GC–MS) NTS protocols, Dulio et al. Environ Sci Eur (2018) 30:5 Page 5 of 13 in connection with the use of structure elucidation and for Water Reuse. Besides the interlaboratory study pollution pattern recognition tools. Besides the Sus- organized in 2009 to assess the comparability of results pect List Exchange database [29] and the “Digital Sam- obtained with a battery of bioassays [38], NORMAN has ple Freezing Platform” [39], the NORMAN MassBank contributed to the estrogen-monitoring project which database [40, 41] was created in 2011 as an open-access has recently provided concrete demonstration data about database of mass spectra which now contains spectra the performance of the tested effect-based methods [49]. of more than 1000 environmental contaminants to sup- A comprehensive in-depth overview of effect-directed port the identification of “unknowns” (i.e., compounds analysis (EDA)—the approach of choice to provide with an unidentified chemical structure). A Collaborative information on the compounds causing the observed Trial (CT) was organized for the first time worldwide in effects—has been published by the respective NORMAN 2013 to study laboratories’ common practices and pro- Working Group to meet the increasing demands for its mote harmonized terminology, workflows, and reporting most efficient application [11]. formats for the use of non-target and suspect screening NORMAN supports the implementation of effect- in the area of environmental analysis [31]. Another key based monitoring tools in water-quality assessment [50]. action was the development of a harmonized model for The integration of effect-based tools and ‘comprehensive’ the prediction of the retention time index (RTI) for NTS NTS techniques has the potential to result in a more and retrospective analysis of a large number of poten- robust identification of priority CECs. In this context, tial emerging substances [42, 43]. The NORMAN RTI EDA may be established in the future as part of the pro- has already been incorporated into the DSFP and it is tocol to be applied at the sites where effect-based trig - expected that it will also soon be included in the open ger values are exceeded. As an advanced screening tool, mass spectral libraries such as MassBank [40], STOFF- instead of time-consuming fractionation followed by IDENT [44], and related platforms (e.g., FOR-IDENT effect tests and NTS, effect-based results and NTS data [45]). of whole samples can be integrated via the application of multivariate analysis (virtual EDA approach), to find cor - Effect‑based tools relations between effects and typical contamination pat - Bioassays are the only currently available methods able terns [43]. to respond to the recently recognized need to address unknown mixture risks present in the water bodies, Passive sampling which can then be related to specific chemical com - NORMAN promotes the use of passive sampling tools, pounds via chemical analysis: instead of measuring a inter alia to address the current lack of temporal repre- limited list of target individual substances known to be sentativeness in water body monitoring and as a supple- responsible for a given effect, it makes more sense to ment to biota monitoring [10, 51]. measure all substances (target substances plus other The interest of NORMAN in passive sampling tech - unknowns) that may contribute to that effect [46]. The niques started as early as 2009 with the organization of EU Water Directors recently supported the proposal a large international interlaboratory study to assess the by the Commission to consider such a more holistic applicability of passive sampling for the monitoring of approach for regulation of chemicals in the aquatic envi- several groups of emerging aquatic pollutants, includ- ronment in view of the WFD review [47] and an effect- ing pharmaceuticals, pesticides, steroid hormones, bro- based methods (EBM). Activity was launched as part of minated diphenyl ethers, and PFOA/PFOS [10, 37]. The the CIS-WFD Programme in 2017 [48]. The successful study showed that the passive sampling process caused introduction of these tools in environmental monitoring less variability in results than the laboratory analysis programs in the future will, however, depend on the suc- and the translation of passive sampling data into water cessful transition from the current system to a new Euro- concentrations. A need was identified for improving the pean framework defining the performance criteria for accuracy of analysis and calibration of adsorption-based the selection of bioassays to be applied, and the QA/QC passive samplers, as well as for more confidence in prac - criteria for validation of the results obtained with these tical application of partition-based passive samplers. new methods, the effect-based trigger (EBT) values nec - Further actions were then organized by NORMAN essary for the interpretation of the data, and the way to [52–54] to investigate how environmental quality stand- proceed when an EBT is exceeded. NORMAN is actively ards (EQS) values relate to results obtained from passive contributing to this process, helping the construction of a sampling and vice versa and to clarify where passive sam- common position of the European experts on the use of pling could fit into the schemes that are currently applied bioassays in the regulatory framework of the WFD and, for assessment of the chemical and ecological status of more recently, in the drafting of the EU policy instrument water bodies under the WFD [51]. Dulio et al. Environ Sci Eur (2018) 30:5 Page 6 of 13 Today, it is well recognized that there is a strong poten- understood effects on ecosystems. NORMAN aims to tial to use passive sampling tools for regulatory purposes, contribute to increased understanding of particle behav- in particular as regards the use of these devices in concert ior in the environment and the resulting consequences with chemical monitoring in biota to support the chemi- for ecosystems. cal status assessment in European water bodies [54, 55]. To that end, NORMAN activities address the fate and To increase the relevance of passive sampling in this transformation of particulate contaminants in natural context, data sets based on concurrent passive sampling (e.g., freshwater, floodplains, and marine systems) and and biota monitoring are strongly needed. Such data technical (wastewater treatment and sewage treatment) sets may need to be developed at the European level and systems. NORMAN will keep working to develop ana- there is an opportunity for NORMAN members to con- lytical methods (including sampling, sample preparation, tribute to federating national on-going initiatives (such as e.g., particle extraction, clean-up, and analytical tools to the large demonstration project organized by AQUAREF detect, quantify, and characterize particulate contami- in France in 2018–2019), to similar studies in other nants in complex matrices) [61]. Finally, NORMAN will European countries. This would facilitate the knowledge contribute as a platform facilitating access to research exchange and harmonization of methodology for better infrastructure and promoting exchanges of methods and comparability of data at European scale. materials. To allow the use of passive sampling data for regulatory In 2016, the NORMAN members decided to add monitoring, it is also important to prepare the basis for microplastics as a new issue under the scope of the NOR- archiving the generated data in appropriate databases in MAN activities [62]. NORMAN expertise in, e.g., data a harmonized format. Here, the contribution of NOR- management, method development, and harmonization MAN experts has resulted in harmonized guidelines is expected to contribute to improve the assessment of for reporting of data obtained by passive sampling tools plastic particles in the environment. [NORMAN Data Collection Templates (DCTs)], which is expected to facilitate the wider exchange of monitoring Wastewater reuse data obtained with passive samplers [43]. Based on these A series of actions are currently being taken by the Com- standardized DCTs, a prototype online database module mission to promote the reuse of treated wastewaters, for passive sampling data has recently been developed including a legislative proposal on minimum require- and tested with JDS3 data [56] within the SOLUTIONS ments for reused water, e.g., for irrigation and ground- project [57]. water recharge [63]. However, a number of questions Additional perspectives arise when considering the are still open and they are crucial to prevent and man- opportunities offered by the combination of passive age health and environmental risks. Important chal- sampling and non-target and suspect screening proce- lenges are, amongst others, associated with the presence dures. Relatively little work has been undertaken in this of non-regulated contaminants, whose environmental area until now. A suitable choice of polymer and extrac- fate and long-term effects are not yet fully understood. tion protocol can enable the scientist to pre-concentrate Moreover, the threat posed by the spread of antibiotic- chemicals from a complex matrix while leaving behind a resistant bacteria and the multiple evidences that domes- significant proportion of unwanted matrix affecting the tic wastewater is amongst their major environmental performance of the analysis. This is especially relevant for reservoirs raise key questions that the scientific commu - complex matrices such as sediments, sludge, or biological nity is committed to answer. Today, there is a consensus matrices. Passive sampling of air, sediments, and water that reclaimed wastewater releases antibiotic-resistant is amenable to non-target approaches, and novel appli- bacteria and their genes. There is, therefore, an urgent cations for sampling of biota [58, 59] or to further our need for better understanding of the presence and fate of understanding of the human exposome are highly prom- micro-contaminants promoting the widespread of antibi- ising [60]. NORMAN, through its cross-working group otic-resistant bacteria and genes in wastewater treatment activities on passive sampling and non-target screening, plant (WWTPs) effluents before their disposal or further is ideally suited for leading this work. reuse [64]. In response to these needs, a new NORMAN activity Other areas of concern that NORMAN is exploring kicked off in 2013 [65] with the commitment to work on: Nano‑ and micro‑scale particulate contaminants (1) the definition and establishment of a harmonized pro - The steeply increasing production volumes of engineered tocol for measurement of antimicrobial resistance; (2) the nanomaterials as well as incidental and natural par- development of a European database to compile infor- ticulate contaminants will eventually lead to a prolifera- mation on the overall abundance and diversity of differ - tion of these materials in the environment, with poorly ent genetic determinands in wastewater effluents and Dulio et al. Environ Sci Eur (2018) 30:5 Page 7 of 13 receiving environments; and (3) the drafting of recom- NILU, Norway to mark the first actions of NORMAN in mendations to the European Commission [64]. this field [72]. Further to the workshop various activities Two screening campaigns of selected ARGs were have already been organized by NORMAN in the field of organized in 2014 and in 2015 on a representative set of CECs in the indoor environment. WWTPs around Europe and Mediterranean countries A collaborative trial on non-target and suspect screen- [66]. Besides the contribution of these campaigns to the ing of indoor dust was launched in 2016 for the identi- assessment of differences in the abundance and diver - fication of pollutants specific to indoor environments, sity of ARGs over distinct municipal wastewater treat- which provides relevant input for harmonization of ment plants and geographic areas, a major follow-up practices and for the definition of a list of CECs relevant of this study was the on-going work of the NORMAN for indoor environment and their prioritization. Strat- experts on the definition of a harmonized protocol and egies for prioritization of CECs indoors are currently interlaboratory calibration criteria to support a reliable being discussed and a subgroup for this task has recently ARG quantification. This is essential to assess the degree been formed, in connection with the already operational of ARG occurrence and environmental contamination, NORMAN Prioritization Working Group. and it has never been done before. Currently, there is The generation of high quality and comparable moni - no baseline on the prevalence of resistance genes in toring data—still scarce and highly scattered in the aquatic (natural) environments and, to obtain this base- indoor environment—and minimum quality require- line, standardized protocols are pivotal. Such a baseline ments for their harmonized storage in a common data- and a better process understanding (and corresponding base is crucial to support prioritization activities. Thanks models) will help to assess the potential risk of antibiotic to NORMAN activities, a new Data Collection Template resistances in the aquatic environment and water reuse. with relevant metadata for indoor air and dust has been Through its activities and collaborations with other rel - developed for the indoor environment module of the evant EU-funded projects (NEREUS [67] and ANSWER NORMAN EMPODAT database. [68]), NORMAN developed in 2017 a new Data Collec- Finally, NORMAN is committed to improving harmo- tion Template used as a basis for a new EMPODAT data- nization of sampling protocols for dust and air. The NOR - base module concerning ARBs and ARGs which will be MAN indoor environment working group made a first fed by this project. inventory of sampling protocols used to collect indoor dust and air. The use of different sampling protocols can Indoor environment result in different particle size fractions collected and There is potential for extending the scope of NORMAN hence in differences in concentrations of SVOCs. There activities to other environmental matrices and com- is, therefore, a great need for an inter-comparison study partments (air, sediments, biota, etc.). Indoor environ- of different dust sampling protocols, and the setting-up ment appears as a relevant key domain for NORMAN’s of a comparison study within NORMAN for sampling missions when looking at the concerns associated with protocols of dust has been proposed for 2018. emerging contaminants in human matrices. Articles and consumer products used indoors may contain a variety Stakeholders’ views and recommendations for the of both well-known chemicals and emerging substances NORMAN network [69–71]. Chemicals are emitted in the indoor environ- The NORMAN Steering Committee organized on the ment and indoor air and dust is an important pathway 10th anniversary of the network [73] a stakeholder work- of chemical exposure for humans. A new NORMAN shop, which took place in Brussels on 26 October 2016. activity for the indoor environment was launched in It attracted about 90 participants, with representatives 2014 aimed at identifying CECs for the indoor environ- from 60 organizations, including the European Commis- ment and at storing respective data in a harmonized way sion, European Chemicals Agency (ECHA) and Euro- in EMPODAT. Measuring goes along with prioritization pean Environment Agency (EEA), national authorities, of relevant compounds in the indoor environment, the research centers, academia, industry, and international identification of emission sources of CECs, and relevant stakeholder organizations. exposure pathways. The ultimate goal of this working National and European agencies, the European Com- group is to raise awareness of CECs in indoor environ- mission, and relevant stakeholders were invited to present ments and possibly to contribute to development of new their experience with the work performed by the network EU legislation regulating the occurrence of CECs in the so far and give their recommendations about NORMAN’s indoor environment [72]. future roadmap, with a view to improving Europe-wide A workshop on “Emerging pollutants in non-industrial collaboration on emerging pollutants and policy-making. indoor environments” was organized in June 2015 at The workshop included two panel discussions. Dulio et al. Environ Sci Eur (2018) 30:5 Page 8 of 13 List of emerging substances Is thesubstancesufficiently investigated andare there sufficient quantified datain therelevant matrix(ces)? Substanceinsuffiently (or never) Substancesufficientlymonitored but Substancesufficientlymonitored monitored lowfrequency of quantification andquantifiedin relevant matrix Sufficient analyticalperformance? yes Sufficient Sufficient LOQ (worst performance) < PNEC? experimental toxicity experimental toxicity no yes datafor risk data forrisk LOQ (best performance) < PNEC? assesment? assesment? yes Risk of exceedance of thelowestPNEC ? yesno no yes no no Cat. 1: Cat. 6: Cat. 3: Cat. 2: Cat. 5 Cat. 4: no Priority for Non-priority Improve Watch list ⇒ Improve Improve(eco)toxi- regular forregular (eco)toxico- occurrence cological data and analytical monitoring monitoring logical data assessment monitoring performance Novelendpoints Fig. 2 Prioritization scheme of the NORMAN network EU Commission DG ENV be more accessible in the future, the question remains According to DG ENV, the tools developed by NOR- whether we are addressing chemical pollution in the MAN are useful to the Commission services and to the environment in a sustainable and efficient manner. There Member States. NORMAN has contributed significantly is the impression of playing catch-up, as there is not yet to the European prioritization process of the WFD with an established mechanism to anticipate the challenges of unique data sets (15% of the monitoring data used in the future. Effect-based tools, non-target screening tech - the review process for the EU priority substances have niques, passive sampling, effects directed analysis, etc. been retrieved from the NORMAN EMPODAT data- are new and promising options for future routine use in base). However, challenges still remain for representative chemicals and water management. monitoring data of sufficient quality and for more holis - However, it needs to be ensured that novel monitoring tic monitoring approaches. J. Romero (DG ENV) high- tools are appropriate for regulatory programs. The extra lighted the following four main challenges. benefit of novel tools needs to be demonstrated and com - As regards river basin-specific pollutants (RBSP), the mon harmonized practices need to be agreed upon by efforts of the Member States clearly indicate that there environment agencies before they can be written into the is a need for improved and more comparable approaches regulations. NORMAN has a clear role here in facilitat- between countries, in terms of both identification and ing the transfer from science to policy. NORMAN can monitoring of RBSP. play an important role in the Common Implementation Prioritization relies largely on sound and comprehen- Strategy (CIS) of the WFD [18], in particular in bring- sive monitoring data. It is widely recognized that the lack ing fresh ideas and testing of new tools to improve future of data is the primary cause of the lack of regulation of strategies for water-quality monitoring. CECs, as a result of the vicious circle where: “no moni- toring means no data, and no data means no regulations”. National agencies: two examples The Commission action to break this vicious circle was NORMAN in support of environmental legislation the introduction of the EU watch list [18] for a short list The feedback from AFB in France was that NOR- of selected compounds. In addition, the Commission MAN helps water managers. The added value of NOR- introduced IPCHEM [4] to collate monitoring data from MAN for national activities is that NORMAN draws the environment and human populations and to make together expertise from across the EU and beyond, these data accessible for regulation, research, and the and promotes synergies across research teams: this public. adds significant value to the CIS in support of the Although monitoring data for regulated substances WFD. Furthermore, NORMAN’s strategic focus and and emerging contaminants will increase in numbers and its ability to help expertise and data sharing stimulate Dulio et al. Environ Sci Eur (2018) 30:5 Page 9 of 13 the development of complementary national R&D International Commission for the Protection of the Danube strategies. River In France, national authorities adopted NORMAN The International Commission for the Protection of the products to develop the national strategies for water Danube River (ICPDR) stated that there is an established management. The mechanism currently used in France fruitful cooperation between the NORMAN network and for the national review of the list of River Basin-Specific the ICPDR, tested most recently on the case study of the Pollutants (RBSPs) and the launch of regular screening third Joint Danube Survey (JDS) which is organized every studies on emerging substances is based on the principles 6  years (2001, 2007, and 2013) by the ICPDR’s 14 mem- of the NORMAN prioritization scheme. ber countries and the EU. In this context, a dedicated “prospective” surveillance In JDS3 (2013), the monitoring involved a number of network has recently been established, which will also new techniques provided by the NORMAN network in involve innovative tools NTS, bioassays and passive sam- synergy with the FP7 SOLUTIONS research project, pling, building upon the results of the NORMAN inter- including effect-based screening using large-volume laboratory studies, recommendation papers, etc. The solid-phase extraction, target, suspect and non-target French case study is a demonstration of how EU member screening of hundreds of organic pollutants using high- states and/or the EU can benefit from NORMAN activi - resolution mass spectrometric techniques and new pas- ties with regard to science-to-policy links. sive sampling approaches to detect trace concentrations The view of AFB is that NORMAN goes beyond net - of CECs. working scientists and research institutes. It also involves The prioritization methodology developed by NOR - regulatory agencies and industry. Thanks to this tripar - MAN, which has been presented to the Monitoring and tite nature, the NORMAN community is aware of the Assessment Expert Group of the ICPDR, was applied to requirements and challenges faced by water managers the JDS3 results and produced a list of 20 pollutants sug- in the implementation of the current legislation and the gested as relevant for the Danube River Basin. These sub - necessary steps for the implementation of innovative stances were presented in the second Danube River Basin tools. Management Plan published in 2015. The above cooperation was proclaimed as a unique The need for monitoring data in chemicals legislation example of science-to-policy action in a wide European The positive impact of NORMAN as regards the genera - context. The next JDS is planned for 2019 and it is already tion of environmental occurrence data was addressed by foreseen that it will include large-scale analysis of CECs the German Environment Ministry with reference to the as well as non-target screening in surface, ground, waste- case of biocides in the aquatic environment and the need water, and biota samples. to improve the legislation for safe marketing of biocidal products. In 2016, NORMAN organized a workshop on Regional Seas Conventions and the Marine Strategy environmental monitoring of biocides in Europe [74]. Framework Directive Monitoring data can tell us whether there are shortcom- The Regional Seas Conventions and the Marine Strat - ings in the authorization procedure, and whether risk egy Framework Directive recommended that NORMAN mitigation measures are designed in a reasonable man- should take an active role in the discussions about CECs ner. They can also serve as a means to better focus sur - in the marine compartment. This would involve active veillance and control measures. support of NORMAN experts in the Regional Sea Con- As yet, far less data for biocides in the environment ventions, non-EU Partners in shared marine basins and are available in comparison with plant protection prod- in the Marine Strategy Framework Directive (MSFD) ucts and pharmaceuticals. New data can create pressure [76] to define a list of compounds of sub-regional con - on policy makers for a level playing field in, e.g., regulat - cern. According to the stakeholder, NORMAN should ing biocides and plant protection products with equiva- also have a role in ensuring improvement of the ability lent protection goals. The Directive 2009/128/EC on the of laboratories to achieve quantification limits (LOQs) “sustainable use of pesticides” [75] adopts an overarch- in line with toxicologically relevant concentrations in the ing approach to reduce the overall risks and impacts of marine environment. pesticides on environment and health. The German Envi - The importance of NTS techniques for the monitor - ronment Ministry emphasized that new monitoring data ing of chemical contaminants in the marine environment for biocides can help to achieve a protection level com- was also stressed. NTS will provide major changes in parable to the sustainable use law for plant protection policy options, but further collaboration is still required products. for its implementation. NORMAN should have a role Dulio et al. Environ Sci Eur (2018) 30:5 Page 10 of 13 in providing an independent review and support for the There is still a need to better investigate individual development and implementation of innovative tech- chemicals of emerging concern and their transformation niques in the marine environment. products by developing analytical methods to determine Finally, there is a need for a repository of geo-refer- occurrence of these compounds in the environment; enced harmonized marine data on emerging substances understanding how they may be released or formed; and from scientific publications and projects. identifying their potential environmental effects. For example, more research and more monitoring data may Key recommendations be needed for persistent and mobile organic compounds, The discussions between scientists and stakeholders i.e., PMOC: they are difficult to remove in WWTPs and involved in policy-making brought up several key recom- they can, therefore, be seen as relevant emerging contam- mendations for NORMAN to continue its activities. inants in the aquatic environment. However, the present Identification and regulation of emerging substances process of ranking and selection of priority substances consist of many challenges for policy and research. They and setting of EQS does not adequately address persistent include population growth and an ageing population, cli- and mobile substance properties. They should, therefore, mate change, new materials, new technologies, and the be given a higher score in the priority substances selec- circular economy. The vision for future chemicals policy tion process to be consistent with the WFD Art. 7, pro- is that pollutants should be dealt with in an integrated tection objectives, as has been recently proposed by [77]. manner in an overarching chemicals policy framework NORMAN has proven to be an efficient platform for new covering all types of chemicals and all uses, beyond the monitoring approaches. NORMAN brings together exper- current sector-specific regulations. tise from leading research groups and is consequently a Monitoring data are established indicators in water reservoir for innovative initiatives. NORMAN will further and chemical management. They are used to safeguard promote the use of both environmental data (chemical con- the effectiveness of environmental policy and to trigger centrations) and biomonitoring data (data from bioassays). new regulatory actions. However, for many substances, There is already clear evidence from recent research studies there are no—or only insufficient—monitoring data. New of the added value of effects based tools, e.g., in the assess - analytical techniques such as NTS are likely to gener- ment of estrogenicity [78–80]. In the future, the range of ate much more chemical monitoring data in the future. endpoints should be broadened to enable wider application A wider picture of contaminants in the environment will in monitoring. This should involve a systematic approach become a challenge for environmental legislation, e.g., for grouping of chemicals in accordance with their mode the WFD and chemical legislation such as REACH and of action, use sector, etc., as the ‘individual substance’ regu- the overarching Commission’s 2018 Strategy for a non- lation is not efficient enough. While the potential benefits toxic environment [15]. of innovative tools and new risk assessment strategies are NORMAN is establishing collaborations with EU beyond question, it is essential to further develop the oper- regulatory bodies, e.g., ECHA. A reliable assessment of ational applicability of these tools for water management chemicals of emerging concern in environmental media routine. Activities organized by NORMAN have already requires exposure data to be linked with information on proven to be effective in laying the ground for the imple - marketed substances. Following this line, it is impor- mentation of new strategies into policy. tant to establish a mutual data exchange between NOR- So far, NORMAN has been strongly involved in issues MAN databases and IPCHEM. Some of the data that related to chemicals of emerging concern in the freshwa- have been generated (e.g., produced by research studies) ter cycle and the associated EU policies. NORMAN has are still kept in databases with restricted access, so that recently extended its scope with the establishment of a they cannot be used for assessment of occurrence levels. new working group on CECs in the indoor environment. For data produced with public funds, there should be a Likewise, there is the potential for new working groups mechanism to make them available to the public authori- for CECs in the marine or the terrestrial environment. ties and institutional bodies by default. Furthermore, the Furthermore, there are new incentives for the integrated example of per- and polyfluorinated alkyl substances assessment and management of chemicals in the envi- (PFAS) indicates the need to look beyond the list of reg- ronment and human populations. Recently, the European istered substances: only 5% of PFAS have a CAS Registry Commission launched the human biomonitoring project Number as a unique, unmistakable identifier for chemi - HBM4EU. NORMAN has the potential to support inte- cal substances. Novel analytical techniques such as NTS grated approaches for CECs and provide data and knowl- can identify the presence of these compounds in the edge for environmental contaminants to be candidate environment. substances for research in human biomonitoring. Dulio et al. Environ Sci Eur (2018) 30:5 Page 11 of 13 drinking water purification effort; EC: European Commission; ECHA: European Finally, a global economy results in worldwide exposure Chemicals Agency; EDA: effect ‑ directed analysis; EEA: European Environment to chemical stressors, including CECs. Other countries Agency; EQS: environmental quality standard; ICPDR: International Commis‑ beyond Europe are interested in the NORMAN activi- sion for the Protection of the Danube River; IPCHEM: European Information Platform for Chemical Monitoring; JDS: Joint Danube Survey; LOQ: limit of ties and Canadian institutions are already partners of the quantification; MSFD: Marine Strategy Framework Directive; NTS: non‑target network. Sooner or later, the extension to other regions screening; PBT: persistent bioaccumulable and toxic; PFAS: polyfluorinated is likely to become an issue for the NORMAN network. alkyl substances; PMOC: persistent and mobile organic compounds; PNEC: predicted no‑ effect concentrations; RBSPs: River Basin‑Specific Pollutants; SVHC: substances of very high concern; REACH: European Regulation on Conclusions Registration, Evaluation, Authorisation and Restriction of Chemicals; UBA: After 10  years of activities, NORMAN has become an Umweltbundesamt (German Federal Environment Agency); WFD: Water Framework Directive. essential network in support of EU policies. NORMAN integrates EU-wide activities on CECs and facilitates the Authors’ contributions transfer of the state-of-the-art scientific knowledge to VD and JK wrote the first draft of the manuscript. All authors read and approved the final manuscript. policy makers and regulatory bodies. Contaminants of emerging concerns are clearly on the Author details EU water policy agenda, e.g., the WFD, and they are also INERIS, National Institute for Environment and Industrial Risks, Verneuil‑en‑Halatte, France. NIVA, Norwegian Institute for Water Research, an important issue of chemicals policy, e.g., the legisla- Oslo, Norway. IVL, Swedish Environmental Research Institute, Stockholm, tion for marketing of plant protection products, biocides, Sweden. Wageningen Environmental Research, Wageningen, The Nether‑ 5 6 and pharmaceuticals. Prioritizing chemicals in the envi- lands. Eawag, Dübendorf, Switzerland. NILU, Norwegian Institute for Air 7 8 Research, Kjeller, Norway. Environmental Institute, Kos, Slovakia. UBA, ronment for regulation is an increasingly important issue. Federal Environment Agency, Dessau‑Roßlau, Germany. Progress in analytical chemistry and increasing moni- toring activities reveal the occurrence of a large number Acknowledgements We would like to acknowledge the very valuable contributions of the invited of chemical substances in the environment. It is, there- experts from stakeholder and institutional bodies who participated in the fore, necessary to complement the traditional approach NORMAN 10th Anniversary workshop in Brussels on 26 October 2016 and for risk assessment with new tools. NORMAN encour- activities of all members of the NORMAN Association in the past decade. ages the development of collaborative R&D strategies Competing interests with a view to their integration into policy. However, The authors declare that they have no competing interests. new techniques and new monitoring approaches need Availability of data and materials to prove that they can be used in regulatory routine pro- Not applicable. grams and that they are cost-efficient. As a collaborative and multidisciplinary platform, NORMAN fosters the Consent for publication Not applicable. exchange of information, validation, and harmonization work and helps the achievement of consensus within the Ethics approval and consent to participate wider international community on the implementation of Not applicable. the research results into policy. Funding The environmental and human exposure to chemicals Not applicable. of emerging concern need to be assessed in a compre- hensive way, taking into account all environmental com- Publisher’s Note partments and the impact on human health. Springer Nature remains neutral with regard to jurisdictional claims in pub‑ lished maps and institutional affiliations. Without the enormous commitment, efforts, and in- kind contributions of the NORMAN members, the NOR- Received: 25 October 2017 Accepted: 22 January 2018 MAN success stories would not have been possible. 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Accessed 8 Jan 2018 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Environmental Sciences Europe Springer Journals

Emerging pollutants in the EU: 10years of NORMAN in support of environmental policies and regulations

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Springer Journals
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Copyright © 2018 by The Author(s)
Subject
Environment; Environment, general; Pollution, general; Ecotoxicology
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2190-4707
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2190-4715
DOI
10.1186/s12302-018-0135-3
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Abstract

In 2005, the European Commission funded the NORMAN project to promote a permanent network of reference labo‑ ratories and research centers, including academia, industry, standardization bodies, and NGOs. Since then, NORMAN has (i) facilitated a more rapid and wide‑ scope exchange of data on the occurrence and effects of contaminants of emerging concern (CECs), (ii) improved data quality and comparability via validation and harmonization of common sampling and measurement methods (chemical and biological), (iii) provided more transparent information and mon‑ itoring data on CECs, and (iv) established an independent and competent forum for the technical/scientific debate on issues related to emerging substances. NORMAN plays a significant role as an independent organization at the interface between science and policy, with the advantage of speaking to the European Commission and other public institutions with the “bigger voice” of more than 70 members from 20 countries. This article provides a summary of the first 10 years of the NORMAN network. It takes stock of the work done so far and outlines NORMAN’s vision for a Europe‑ wide collaboration on CECs and sustainable links from research to policy‑ making. It contains an overview of the state of play in prioritizing and monitoring emerging substances with reference to several innovative technolo‑ gies and monitoring approaches. It provides the point of view of the NORMAN network on a burning issue—the regulation of CECs—and presents the positions of various stakeholders in the field (DG ENV, EEA, ECHA, and national agencies) who participated in the NORMAN workshop in October 2016. The main messages and conclusions from the round table discussions are briefly presented. Keywords: NORMAN network, Emerging substances, Contaminants of emerging concern, Science‑ to‑ policy, Environmental monitoring chemicals that are currently not regulated (not submitted Background to a routine monitoring and/or emission control regime), This paper, triggered by the 10th anniversary of the NOR - but may be under scrutiny for future regulation. In addi- MAN Association [1] and the outcomes of the workshop tion, it is now common knowledge that the contaminants that was organized to mark this occasion, discusses the of interest are not necessarily newly developed chemi- work performed within the NORMAN network over the cals: most CECs are substances that have entered the last 10  years and the way forward to improving Europe- environment for years, even decades, but their presence wide collaboration on CECs and related policy-making. has only recently begun to be investigated. Most known It is now about a decade, since the term “contaminants CECs include industrial compounds, pharmaceuticals, of emerging concern” (CECs) became a common term for personal-care products, biocides, and plant protection products, but the list of compounds is constantly grow- *Correspondence: valeria.dulio@ineris.fr ing and this is not surprising when we consider that more INERIS, National Institute for Environment and Industrial Risks, than 100 million chemical substances are currently regis- Verneuil‑en‑Halatte, France tered in the Chemical Abstracts Service (CAS) and about Full list of author information is available at the end of the article © The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Dulio et al. Environ Sci Eur (2018) 30:5 Page 2 of 13 4000 new ones are registered every day. According to the To achieve these goals, NORMAN brings together not number of registered and pre-registered substances in only the scientific community on emerging substances REACH, 30,000–50,000 industrial chemicals are found but also the many agencies actively involved in the deci- in daily-use products [2, 3] and they are potentially ulti- sion-making on emerging substances and even private mately released into the environment. Chemicals are eve- companies. The multidisciplinary membership of NOR - rywhere, in the water we drink, in the food that we eat in MAN has proven to be a strong point as it helps to pull the homes in which we live. knowledge of emerging substances together and pushes There are increasing concerns about the combined the latest scientific findings towards policy-making. The effects of this multitude of chemicals as they enter the activities are organized in eight working groups dealing environment and the food chain, although each chemical with different CECs aspects, i.e., prioritization, effect- used in a minute quantity may be considered harmless [4, based tools, effect-directed analysis, nanomaterials, 5]. In addition, there is today a general consensus among wastewater reuse, indoor environment as well as two policy-makers that emerging substances need to be cross-working group activities on passive sampling and addressed in a systematic and coherent manner. It is also non-target screening (Fig. 1). widely accepted that there is a need for an early warn- NORMAN publishes a bulletin on CECs, with informa- ing system able to play the role of the “watchdog”. Such tion on current initiatives, results of collaborative pro- a system should anticipate the risks associated with the jects and future perspectives in the field [8]. More than dynamic change in the use of chemicals so as to prevent 30 international events [9] have been organized by NOR- the environmental impact of chemical substances before MAN since 2006 and position papers have been pub- they become “contaminants of emerging concern”. In lished on various relevant topics by NORMAN experts, other words, our ultimate objective should be to advance such as passive sampling [10], effect-directed analysis our knowledge and environmental monitoring abilities to [11], and more recently a paper with 10 recommenda- the point, where the need for the term “emerging” disap- tions [12] for the review of the Water Framework Direc- pears altogether [6]. tive (WFD) [13], developed in collaboration with the In 2004, NORMAN came into existence following a SOLUTIONS project [14]. call by the EU Commission (DG Research) to create “a The stakeholders at the 10th anniversary workshop permanent network of reference laboratories and related unanimously agreed that NORMAN has succeeded in organizations dealing with emerging environmental sub- building a strong infrastructure and developing tools to stances” [7]. Its main objectives—on which it has been connect science and policy. NORMAN has also proven working actively over the past 10  years—are to improve to be a good platform to reach consensus among experts the exchange of information on emerging substances and for harmonization of practices. to foster harmonization of protocols and improvement of Overall, NORMAN aims to play the long-term role of data quality. global early-warning platform for CECs, closely related Today, NORMAN is an independent and highly recog- to the non-toxic environment strategy [15]. nized network of reference laboratories, research centers, and related organizations for the monitoring of contami- NORMAN achievements and future perspectives nants of emerging concern. In 2006, its first full year of A first consideration when speaking about NORMAN’s operation, it was a consortium of 17 members; today, it achievements over the last 10 years is that NORMAN has is a self-sustaining, non-profit organization of more than been able to establish and operate a collaboration mecha- 70 members. nism to deal with the following crucial questions about Five pillars constitute the NORMAN objectives: emerging substances: What are the most suitable tech- niques and strategies to identify and prioritize poten- tial problematic chemicals? Do we have enough data to • Independent, transparent, and open network, work- assess the risks associated with CECs? Do the data pass ing for a sustainable environment without harmful quality criteria and are they representative enough? And substances. do we have access to all the data that are available? • Go-to organization for issues on emerging sub- stances in the environment. Prioritization of CECs • Watchdog and alarm bell for emerging environmen- The prioritization of chemical contaminants is a task of tal threats. primary importance for environmental managers and the • Bridge between science and policy-making. scientific community, for the definition of priority actions • Platform for innovative bottom–up initiatives to for pollution prevention and control, and the efficient explore new monitoring challenges. allocation of resources to address current knowledge Dulio et al. Environ Sci Eur (2018) 30:5 Page 3 of 13 gaps. Starting from the observation that, for most emerg- exploitation of raw monitoring data to support prioritiza- ing substances, it is primarily the knowledge gaps which tion exercises. This is closely connected with the second still prevent proper risk assessment and risk ranking, pillar, the EMPODAT ECOTOX module, a platform for NORMAN has developed a rational and holistic prior- systematic collection and evaluation of the relevance and itization approach (Fig.  2) which gives more systematic reliability of ecotoxicity studies which aims to become an consideration to the knowledge gaps relating to emerg- essential tool for the European community of ecotoxicol- ing substances [16, 17]. The scheme has been used by ogists for the derivation and harmonization of predicted NORMAN to provide recommendations to the European no-effect concentration (PNEC) threshold levels. NTS, Commission for the prioritization of the compounds the third pillar, includes recent workflows for the appli - on the first European Watch List [18] and has also been cation and evaluation of high-resolution mass spectrom- adopted by regulatory agencies in France [19, 20] and in etry for identification of suspects and unknowns. The Slovakia [21]. results from NTS, i.e., checking presence/absence and In the light of the experience acquired, NORMAN is semi-quantitative information about these compounds now committed to the further development of the cur- in a large number of samples by NORMAN partners in rent scheme with the extension of the original NOR- different countries, will help in the future to prioritize MAN list of substances (ca. 900 compounds) to a much the most relevant compounds for possible further evalu- larger list of several thousands of compounds. This goes ation as substances of potential regulatory concern. The along with the establishment of dynamic links with exist- collaborative NormaNEWS [25] joint activity has already ing databases (such as, for example, the US EPA Comp- successfully demonstrated the usefulness of the retro- Tox Chemistry Dashboard [22]) for a more powerful and spective screening of high-resolution mass spectrometric systematic retrieval of supporting data for prioritization data in establishing the spatial and temporal occurrences of substances, and the introduction of new indicators for of newly identified compounds of potential emerging better integration of the results from novel monitoring- concern [26]. based approaches, such as suspect and non-target screen- ing (NTS) as well as effect-based methods (EBM) in the Data collection and data management prioritization process. NORMAN fosters an integrative Reliable identification and prioritization of relevant CECs approach for the prioritization of CECs [23], which relies is strongly dependent on the quality and quantity of on three pillars: the first is EMPODAT [24], a powerful archived monitoring data. The development of databases database system which has been developed to store the such as EMPODAT and improvement of data exchange monitoring data collected by NORMAN members and have been NORMAN’s core business since the start of as a tool for use by regulators and scientists alike for the the project. A clear need was identified at the time of the prioritization of CECs. Its added value will be further launch of the NORMAN project, which was confirmed increased in the future thanks to its full integration into by the first NORMAN Databases workshop in 2011 [27], the European Information Platform for Chemical Moni- where experts concluded that, in spite of the numerous toring (IPCHEM) [4], which will improve systematic chemical monitoring activities carried out in the EU and WG1 WG2 WG3 Prioritisation of emerging substances Bioassays and biomarkers in water Effect-directed analysis for hazardous quality monitoring pollutants identification Cross-Working Group Activity: Passive sampling(PS) Passive sampling for emerging contaminants Cross-Working Group Activity Non-target Screening (NTS) Non-target screening techniques for environmental monitoring WG4 WG5 WG6 Nano-and micro scale particulate Wastewater reuse and Contaminants of Emerging substances in the indoor contaminants Emerging Concern environment Fig. 1 Overview of the NORMAN Working Groups Dulio et al. Environ Sci Eur (2018) 30:5 Page 4 of 13 worldwide and the significant amounts of data generated collaborating in one DSFP and sharing its ‘big data’ has by the scientific community within research projects, been recently tested among a core group of NORMAN, environmental monitoring data were not systematically with data sets obtained within the Joint Danube Survey collected at the EU level [28]. EMPODAT [24] is today 3 (surface water samples) [31] and the EU/UNDP EMB- the largest database on emerging substances worldwide, LAS project (marine water, sediment, and biota sam- with about ten million data records for more than 500 ples) [32]. Further improvement of functionalities of the emerging substances. The interest and contribution of DSFP (upload of raw mass chromatograms, visualisation the network partners have enabled the database system of data, batch mode processing, use of MS–MS informa- to constantly grow, and new modules for accommoda- tion, etc.), the extension of its functionalities for archiv- tion of passive sampling, indoor environment, bioassays ing and processing of gas chromatography–HR-MS data monitoring, antibiotic-resistant bacteria (ARBs), and and testing of various options for archiving and process- antibiotic-resistant genes (ARGs) data are now under ing of ‘big data’ at the wider European scale are planned development. Besides that, the ECOTOX module already for 2018 and beyond. contains predicted and experimental PNECs for more than 13,000 substances and its sustainable growth is one Methods’ harmonization and validation of the priority tasks of the NORMAN network. The trend The NORMAN community is recognized as particularly is clearly towards encouraging data sharing, improving strong in analytical matters and the studies organized access and use of available data along with improvement by the network represent a crucial step for the scientific of their quality. The value of the NORMAN platform is community and for environmental agencies in the prepa- fully recognized by the European Commission, with ration of the ground for validation and harmonization of which NORMAN has recently started a close collabora- innovative sampling and monitoring tools before their tion to achieve permanent integration of EMPODAT in possible future implementation in regulations. IPCHEM [4]. As regards improvement of data quality, one major achievement of NORMAN has been the development Evolution towards “big data” management: from hundreds of a common framework for validation of chemical and to tens of thousands of candidate substances biological monitoring methods—a protocol which is We are increasingly aware that there is a need to evolve now adopted as a Technical Specification (TS) of the towards a system able to deal with several thousands European Committee for Standardization (CEN) (CEN of compounds which may enter the environment. TS 16800:2015) [33, 34]. In other words, NORMAN has NORMAN is already working to replace the original defined a clear list of “rules” that the laboratories need “NORMAN list of emerging substances” of about 900 to observe to be able to state that their method is “vali- compounds with a much larger list of substances. The dated”—and it is well known how method validation is NORMAN Suspect List Exchange database (SusDat) crucial, especially when it comes to the measurement of database [29] has recently been launched and already substances which laboratories are not familiar with, with includes more than 40,000 compounds as a common clear consequences for the quality and reliability of the effort of European and North American researchers. All results produced. Besides that, NORMAN has organized suspect lists currently available in SusDat can be viewed interlaboratory studies on substances of priority inter- at the NORMAN website and are being progressively est in research [35, 36] and has more recently extended integrated into the US EPA CompTox Chemistry Dash- these inter-comparison activities to passive sampling board [22]. This large list will become the new “universe” [37], bioassays [38], and non-target screening methods of compounds for prioritization, and the NORMAN List [31]. will be defined as the list of top priority compounds in each prioritization action category. New tools to improve future monitoring and regulation Non-target screening analysis, combined with the inte- of CECs gration of high-performance computing, becomes “ready Non‑target screening to go” for environmental applications [30] and moves In line with the strong expertise of the NORMAN net- traditional exposure analysis to ‘big data’: the NORMAN work in the field of high-resolution mass spectrometry ‘Digital Sample Freezing Platform (DSFP)’ is currently techniques and NTS approaches, several activities have under development to host in a harmonized format full- been launched over the past years and continue to be scan high-resolution mass spectrometry (HR-MS) data, promoted to improve harmonization of liquid chroma- allowing for high-throughput processing (including ret- tography coupled to high-resolution tandem mass spec- rospective analysis) of any environmental sample for a trometry [LC–HR-MS(MS)] and gas chromatography wide range (thousands) of pollutants. The concept of coupled to mass spectrometry (GC–MS) NTS protocols, Dulio et al. Environ Sci Eur (2018) 30:5 Page 5 of 13 in connection with the use of structure elucidation and for Water Reuse. Besides the interlaboratory study pollution pattern recognition tools. Besides the Sus- organized in 2009 to assess the comparability of results pect List Exchange database [29] and the “Digital Sam- obtained with a battery of bioassays [38], NORMAN has ple Freezing Platform” [39], the NORMAN MassBank contributed to the estrogen-monitoring project which database [40, 41] was created in 2011 as an open-access has recently provided concrete demonstration data about database of mass spectra which now contains spectra the performance of the tested effect-based methods [49]. of more than 1000 environmental contaminants to sup- A comprehensive in-depth overview of effect-directed port the identification of “unknowns” (i.e., compounds analysis (EDA)—the approach of choice to provide with an unidentified chemical structure). A Collaborative information on the compounds causing the observed Trial (CT) was organized for the first time worldwide in effects—has been published by the respective NORMAN 2013 to study laboratories’ common practices and pro- Working Group to meet the increasing demands for its mote harmonized terminology, workflows, and reporting most efficient application [11]. formats for the use of non-target and suspect screening NORMAN supports the implementation of effect- in the area of environmental analysis [31]. Another key based monitoring tools in water-quality assessment [50]. action was the development of a harmonized model for The integration of effect-based tools and ‘comprehensive’ the prediction of the retention time index (RTI) for NTS NTS techniques has the potential to result in a more and retrospective analysis of a large number of poten- robust identification of priority CECs. In this context, tial emerging substances [42, 43]. The NORMAN RTI EDA may be established in the future as part of the pro- has already been incorporated into the DSFP and it is tocol to be applied at the sites where effect-based trig - expected that it will also soon be included in the open ger values are exceeded. As an advanced screening tool, mass spectral libraries such as MassBank [40], STOFF- instead of time-consuming fractionation followed by IDENT [44], and related platforms (e.g., FOR-IDENT effect tests and NTS, effect-based results and NTS data [45]). of whole samples can be integrated via the application of multivariate analysis (virtual EDA approach), to find cor - Effect‑based tools relations between effects and typical contamination pat - Bioassays are the only currently available methods able terns [43]. to respond to the recently recognized need to address unknown mixture risks present in the water bodies, Passive sampling which can then be related to specific chemical com - NORMAN promotes the use of passive sampling tools, pounds via chemical analysis: instead of measuring a inter alia to address the current lack of temporal repre- limited list of target individual substances known to be sentativeness in water body monitoring and as a supple- responsible for a given effect, it makes more sense to ment to biota monitoring [10, 51]. measure all substances (target substances plus other The interest of NORMAN in passive sampling tech - unknowns) that may contribute to that effect [46]. The niques started as early as 2009 with the organization of EU Water Directors recently supported the proposal a large international interlaboratory study to assess the by the Commission to consider such a more holistic applicability of passive sampling for the monitoring of approach for regulation of chemicals in the aquatic envi- several groups of emerging aquatic pollutants, includ- ronment in view of the WFD review [47] and an effect- ing pharmaceuticals, pesticides, steroid hormones, bro- based methods (EBM). Activity was launched as part of minated diphenyl ethers, and PFOA/PFOS [10, 37]. The the CIS-WFD Programme in 2017 [48]. The successful study showed that the passive sampling process caused introduction of these tools in environmental monitoring less variability in results than the laboratory analysis programs in the future will, however, depend on the suc- and the translation of passive sampling data into water cessful transition from the current system to a new Euro- concentrations. A need was identified for improving the pean framework defining the performance criteria for accuracy of analysis and calibration of adsorption-based the selection of bioassays to be applied, and the QA/QC passive samplers, as well as for more confidence in prac - criteria for validation of the results obtained with these tical application of partition-based passive samplers. new methods, the effect-based trigger (EBT) values nec - Further actions were then organized by NORMAN essary for the interpretation of the data, and the way to [52–54] to investigate how environmental quality stand- proceed when an EBT is exceeded. NORMAN is actively ards (EQS) values relate to results obtained from passive contributing to this process, helping the construction of a sampling and vice versa and to clarify where passive sam- common position of the European experts on the use of pling could fit into the schemes that are currently applied bioassays in the regulatory framework of the WFD and, for assessment of the chemical and ecological status of more recently, in the drafting of the EU policy instrument water bodies under the WFD [51]. Dulio et al. Environ Sci Eur (2018) 30:5 Page 6 of 13 Today, it is well recognized that there is a strong poten- understood effects on ecosystems. NORMAN aims to tial to use passive sampling tools for regulatory purposes, contribute to increased understanding of particle behav- in particular as regards the use of these devices in concert ior in the environment and the resulting consequences with chemical monitoring in biota to support the chemi- for ecosystems. cal status assessment in European water bodies [54, 55]. To that end, NORMAN activities address the fate and To increase the relevance of passive sampling in this transformation of particulate contaminants in natural context, data sets based on concurrent passive sampling (e.g., freshwater, floodplains, and marine systems) and and biota monitoring are strongly needed. Such data technical (wastewater treatment and sewage treatment) sets may need to be developed at the European level and systems. NORMAN will keep working to develop ana- there is an opportunity for NORMAN members to con- lytical methods (including sampling, sample preparation, tribute to federating national on-going initiatives (such as e.g., particle extraction, clean-up, and analytical tools to the large demonstration project organized by AQUAREF detect, quantify, and characterize particulate contami- in France in 2018–2019), to similar studies in other nants in complex matrices) [61]. Finally, NORMAN will European countries. This would facilitate the knowledge contribute as a platform facilitating access to research exchange and harmonization of methodology for better infrastructure and promoting exchanges of methods and comparability of data at European scale. materials. To allow the use of passive sampling data for regulatory In 2016, the NORMAN members decided to add monitoring, it is also important to prepare the basis for microplastics as a new issue under the scope of the NOR- archiving the generated data in appropriate databases in MAN activities [62]. NORMAN expertise in, e.g., data a harmonized format. Here, the contribution of NOR- management, method development, and harmonization MAN experts has resulted in harmonized guidelines is expected to contribute to improve the assessment of for reporting of data obtained by passive sampling tools plastic particles in the environment. [NORMAN Data Collection Templates (DCTs)], which is expected to facilitate the wider exchange of monitoring Wastewater reuse data obtained with passive samplers [43]. Based on these A series of actions are currently being taken by the Com- standardized DCTs, a prototype online database module mission to promote the reuse of treated wastewaters, for passive sampling data has recently been developed including a legislative proposal on minimum require- and tested with JDS3 data [56] within the SOLUTIONS ments for reused water, e.g., for irrigation and ground- project [57]. water recharge [63]. However, a number of questions Additional perspectives arise when considering the are still open and they are crucial to prevent and man- opportunities offered by the combination of passive age health and environmental risks. Important chal- sampling and non-target and suspect screening proce- lenges are, amongst others, associated with the presence dures. Relatively little work has been undertaken in this of non-regulated contaminants, whose environmental area until now. A suitable choice of polymer and extrac- fate and long-term effects are not yet fully understood. tion protocol can enable the scientist to pre-concentrate Moreover, the threat posed by the spread of antibiotic- chemicals from a complex matrix while leaving behind a resistant bacteria and the multiple evidences that domes- significant proportion of unwanted matrix affecting the tic wastewater is amongst their major environmental performance of the analysis. This is especially relevant for reservoirs raise key questions that the scientific commu - complex matrices such as sediments, sludge, or biological nity is committed to answer. Today, there is a consensus matrices. Passive sampling of air, sediments, and water that reclaimed wastewater releases antibiotic-resistant is amenable to non-target approaches, and novel appli- bacteria and their genes. There is, therefore, an urgent cations for sampling of biota [58, 59] or to further our need for better understanding of the presence and fate of understanding of the human exposome are highly prom- micro-contaminants promoting the widespread of antibi- ising [60]. NORMAN, through its cross-working group otic-resistant bacteria and genes in wastewater treatment activities on passive sampling and non-target screening, plant (WWTPs) effluents before their disposal or further is ideally suited for leading this work. reuse [64]. In response to these needs, a new NORMAN activity Other areas of concern that NORMAN is exploring kicked off in 2013 [65] with the commitment to work on: Nano‑ and micro‑scale particulate contaminants (1) the definition and establishment of a harmonized pro - The steeply increasing production volumes of engineered tocol for measurement of antimicrobial resistance; (2) the nanomaterials as well as incidental and natural par- development of a European database to compile infor- ticulate contaminants will eventually lead to a prolifera- mation on the overall abundance and diversity of differ - tion of these materials in the environment, with poorly ent genetic determinands in wastewater effluents and Dulio et al. Environ Sci Eur (2018) 30:5 Page 7 of 13 receiving environments; and (3) the drafting of recom- NILU, Norway to mark the first actions of NORMAN in mendations to the European Commission [64]. this field [72]. Further to the workshop various activities Two screening campaigns of selected ARGs were have already been organized by NORMAN in the field of organized in 2014 and in 2015 on a representative set of CECs in the indoor environment. WWTPs around Europe and Mediterranean countries A collaborative trial on non-target and suspect screen- [66]. Besides the contribution of these campaigns to the ing of indoor dust was launched in 2016 for the identi- assessment of differences in the abundance and diver - fication of pollutants specific to indoor environments, sity of ARGs over distinct municipal wastewater treat- which provides relevant input for harmonization of ment plants and geographic areas, a major follow-up practices and for the definition of a list of CECs relevant of this study was the on-going work of the NORMAN for indoor environment and their prioritization. Strat- experts on the definition of a harmonized protocol and egies for prioritization of CECs indoors are currently interlaboratory calibration criteria to support a reliable being discussed and a subgroup for this task has recently ARG quantification. This is essential to assess the degree been formed, in connection with the already operational of ARG occurrence and environmental contamination, NORMAN Prioritization Working Group. and it has never been done before. Currently, there is The generation of high quality and comparable moni - no baseline on the prevalence of resistance genes in toring data—still scarce and highly scattered in the aquatic (natural) environments and, to obtain this base- indoor environment—and minimum quality require- line, standardized protocols are pivotal. Such a baseline ments for their harmonized storage in a common data- and a better process understanding (and corresponding base is crucial to support prioritization activities. Thanks models) will help to assess the potential risk of antibiotic to NORMAN activities, a new Data Collection Template resistances in the aquatic environment and water reuse. with relevant metadata for indoor air and dust has been Through its activities and collaborations with other rel - developed for the indoor environment module of the evant EU-funded projects (NEREUS [67] and ANSWER NORMAN EMPODAT database. [68]), NORMAN developed in 2017 a new Data Collec- Finally, NORMAN is committed to improving harmo- tion Template used as a basis for a new EMPODAT data- nization of sampling protocols for dust and air. The NOR - base module concerning ARBs and ARGs which will be MAN indoor environment working group made a first fed by this project. inventory of sampling protocols used to collect indoor dust and air. The use of different sampling protocols can Indoor environment result in different particle size fractions collected and There is potential for extending the scope of NORMAN hence in differences in concentrations of SVOCs. There activities to other environmental matrices and com- is, therefore, a great need for an inter-comparison study partments (air, sediments, biota, etc.). Indoor environ- of different dust sampling protocols, and the setting-up ment appears as a relevant key domain for NORMAN’s of a comparison study within NORMAN for sampling missions when looking at the concerns associated with protocols of dust has been proposed for 2018. emerging contaminants in human matrices. Articles and consumer products used indoors may contain a variety Stakeholders’ views and recommendations for the of both well-known chemicals and emerging substances NORMAN network [69–71]. Chemicals are emitted in the indoor environ- The NORMAN Steering Committee organized on the ment and indoor air and dust is an important pathway 10th anniversary of the network [73] a stakeholder work- of chemical exposure for humans. A new NORMAN shop, which took place in Brussels on 26 October 2016. activity for the indoor environment was launched in It attracted about 90 participants, with representatives 2014 aimed at identifying CECs for the indoor environ- from 60 organizations, including the European Commis- ment and at storing respective data in a harmonized way sion, European Chemicals Agency (ECHA) and Euro- in EMPODAT. Measuring goes along with prioritization pean Environment Agency (EEA), national authorities, of relevant compounds in the indoor environment, the research centers, academia, industry, and international identification of emission sources of CECs, and relevant stakeholder organizations. exposure pathways. The ultimate goal of this working National and European agencies, the European Com- group is to raise awareness of CECs in indoor environ- mission, and relevant stakeholders were invited to present ments and possibly to contribute to development of new their experience with the work performed by the network EU legislation regulating the occurrence of CECs in the so far and give their recommendations about NORMAN’s indoor environment [72]. future roadmap, with a view to improving Europe-wide A workshop on “Emerging pollutants in non-industrial collaboration on emerging pollutants and policy-making. indoor environments” was organized in June 2015 at The workshop included two panel discussions. Dulio et al. Environ Sci Eur (2018) 30:5 Page 8 of 13 List of emerging substances Is thesubstancesufficiently investigated andare there sufficient quantified datain therelevant matrix(ces)? Substanceinsuffiently (or never) Substancesufficientlymonitored but Substancesufficientlymonitored monitored lowfrequency of quantification andquantifiedin relevant matrix Sufficient analyticalperformance? yes Sufficient Sufficient LOQ (worst performance) < PNEC? experimental toxicity experimental toxicity no yes datafor risk data forrisk LOQ (best performance) < PNEC? assesment? assesment? yes Risk of exceedance of thelowestPNEC ? yesno no yes no no Cat. 1: Cat. 6: Cat. 3: Cat. 2: Cat. 5 Cat. 4: no Priority for Non-priority Improve Watch list ⇒ Improve Improve(eco)toxi- regular forregular (eco)toxico- occurrence cological data and analytical monitoring monitoring logical data assessment monitoring performance Novelendpoints Fig. 2 Prioritization scheme of the NORMAN network EU Commission DG ENV be more accessible in the future, the question remains According to DG ENV, the tools developed by NOR- whether we are addressing chemical pollution in the MAN are useful to the Commission services and to the environment in a sustainable and efficient manner. There Member States. NORMAN has contributed significantly is the impression of playing catch-up, as there is not yet to the European prioritization process of the WFD with an established mechanism to anticipate the challenges of unique data sets (15% of the monitoring data used in the future. Effect-based tools, non-target screening tech - the review process for the EU priority substances have niques, passive sampling, effects directed analysis, etc. been retrieved from the NORMAN EMPODAT data- are new and promising options for future routine use in base). However, challenges still remain for representative chemicals and water management. monitoring data of sufficient quality and for more holis - However, it needs to be ensured that novel monitoring tic monitoring approaches. J. Romero (DG ENV) high- tools are appropriate for regulatory programs. The extra lighted the following four main challenges. benefit of novel tools needs to be demonstrated and com - As regards river basin-specific pollutants (RBSP), the mon harmonized practices need to be agreed upon by efforts of the Member States clearly indicate that there environment agencies before they can be written into the is a need for improved and more comparable approaches regulations. NORMAN has a clear role here in facilitat- between countries, in terms of both identification and ing the transfer from science to policy. NORMAN can monitoring of RBSP. play an important role in the Common Implementation Prioritization relies largely on sound and comprehen- Strategy (CIS) of the WFD [18], in particular in bring- sive monitoring data. It is widely recognized that the lack ing fresh ideas and testing of new tools to improve future of data is the primary cause of the lack of regulation of strategies for water-quality monitoring. CECs, as a result of the vicious circle where: “no moni- toring means no data, and no data means no regulations”. National agencies: two examples The Commission action to break this vicious circle was NORMAN in support of environmental legislation the introduction of the EU watch list [18] for a short list The feedback from AFB in France was that NOR- of selected compounds. In addition, the Commission MAN helps water managers. The added value of NOR- introduced IPCHEM [4] to collate monitoring data from MAN for national activities is that NORMAN draws the environment and human populations and to make together expertise from across the EU and beyond, these data accessible for regulation, research, and the and promotes synergies across research teams: this public. adds significant value to the CIS in support of the Although monitoring data for regulated substances WFD. Furthermore, NORMAN’s strategic focus and and emerging contaminants will increase in numbers and its ability to help expertise and data sharing stimulate Dulio et al. Environ Sci Eur (2018) 30:5 Page 9 of 13 the development of complementary national R&D International Commission for the Protection of the Danube strategies. River In France, national authorities adopted NORMAN The International Commission for the Protection of the products to develop the national strategies for water Danube River (ICPDR) stated that there is an established management. The mechanism currently used in France fruitful cooperation between the NORMAN network and for the national review of the list of River Basin-Specific the ICPDR, tested most recently on the case study of the Pollutants (RBSPs) and the launch of regular screening third Joint Danube Survey (JDS) which is organized every studies on emerging substances is based on the principles 6  years (2001, 2007, and 2013) by the ICPDR’s 14 mem- of the NORMAN prioritization scheme. ber countries and the EU. In this context, a dedicated “prospective” surveillance In JDS3 (2013), the monitoring involved a number of network has recently been established, which will also new techniques provided by the NORMAN network in involve innovative tools NTS, bioassays and passive sam- synergy with the FP7 SOLUTIONS research project, pling, building upon the results of the NORMAN inter- including effect-based screening using large-volume laboratory studies, recommendation papers, etc. The solid-phase extraction, target, suspect and non-target French case study is a demonstration of how EU member screening of hundreds of organic pollutants using high- states and/or the EU can benefit from NORMAN activi - resolution mass spectrometric techniques and new pas- ties with regard to science-to-policy links. sive sampling approaches to detect trace concentrations The view of AFB is that NORMAN goes beyond net - of CECs. working scientists and research institutes. It also involves The prioritization methodology developed by NOR - regulatory agencies and industry. Thanks to this tripar - MAN, which has been presented to the Monitoring and tite nature, the NORMAN community is aware of the Assessment Expert Group of the ICPDR, was applied to requirements and challenges faced by water managers the JDS3 results and produced a list of 20 pollutants sug- in the implementation of the current legislation and the gested as relevant for the Danube River Basin. These sub - necessary steps for the implementation of innovative stances were presented in the second Danube River Basin tools. Management Plan published in 2015. The above cooperation was proclaimed as a unique The need for monitoring data in chemicals legislation example of science-to-policy action in a wide European The positive impact of NORMAN as regards the genera - context. The next JDS is planned for 2019 and it is already tion of environmental occurrence data was addressed by foreseen that it will include large-scale analysis of CECs the German Environment Ministry with reference to the as well as non-target screening in surface, ground, waste- case of biocides in the aquatic environment and the need water, and biota samples. to improve the legislation for safe marketing of biocidal products. In 2016, NORMAN organized a workshop on Regional Seas Conventions and the Marine Strategy environmental monitoring of biocides in Europe [74]. Framework Directive Monitoring data can tell us whether there are shortcom- The Regional Seas Conventions and the Marine Strat - ings in the authorization procedure, and whether risk egy Framework Directive recommended that NORMAN mitigation measures are designed in a reasonable man- should take an active role in the discussions about CECs ner. They can also serve as a means to better focus sur - in the marine compartment. This would involve active veillance and control measures. support of NORMAN experts in the Regional Sea Con- As yet, far less data for biocides in the environment ventions, non-EU Partners in shared marine basins and are available in comparison with plant protection prod- in the Marine Strategy Framework Directive (MSFD) ucts and pharmaceuticals. New data can create pressure [76] to define a list of compounds of sub-regional con - on policy makers for a level playing field in, e.g., regulat - cern. According to the stakeholder, NORMAN should ing biocides and plant protection products with equiva- also have a role in ensuring improvement of the ability lent protection goals. The Directive 2009/128/EC on the of laboratories to achieve quantification limits (LOQs) “sustainable use of pesticides” [75] adopts an overarch- in line with toxicologically relevant concentrations in the ing approach to reduce the overall risks and impacts of marine environment. pesticides on environment and health. The German Envi - The importance of NTS techniques for the monitor - ronment Ministry emphasized that new monitoring data ing of chemical contaminants in the marine environment for biocides can help to achieve a protection level com- was also stressed. NTS will provide major changes in parable to the sustainable use law for plant protection policy options, but further collaboration is still required products. for its implementation. NORMAN should have a role Dulio et al. Environ Sci Eur (2018) 30:5 Page 10 of 13 in providing an independent review and support for the There is still a need to better investigate individual development and implementation of innovative tech- chemicals of emerging concern and their transformation niques in the marine environment. products by developing analytical methods to determine Finally, there is a need for a repository of geo-refer- occurrence of these compounds in the environment; enced harmonized marine data on emerging substances understanding how they may be released or formed; and from scientific publications and projects. identifying their potential environmental effects. For example, more research and more monitoring data may Key recommendations be needed for persistent and mobile organic compounds, The discussions between scientists and stakeholders i.e., PMOC: they are difficult to remove in WWTPs and involved in policy-making brought up several key recom- they can, therefore, be seen as relevant emerging contam- mendations for NORMAN to continue its activities. inants in the aquatic environment. However, the present Identification and regulation of emerging substances process of ranking and selection of priority substances consist of many challenges for policy and research. They and setting of EQS does not adequately address persistent include population growth and an ageing population, cli- and mobile substance properties. They should, therefore, mate change, new materials, new technologies, and the be given a higher score in the priority substances selec- circular economy. The vision for future chemicals policy tion process to be consistent with the WFD Art. 7, pro- is that pollutants should be dealt with in an integrated tection objectives, as has been recently proposed by [77]. manner in an overarching chemicals policy framework NORMAN has proven to be an efficient platform for new covering all types of chemicals and all uses, beyond the monitoring approaches. NORMAN brings together exper- current sector-specific regulations. tise from leading research groups and is consequently a Monitoring data are established indicators in water reservoir for innovative initiatives. NORMAN will further and chemical management. They are used to safeguard promote the use of both environmental data (chemical con- the effectiveness of environmental policy and to trigger centrations) and biomonitoring data (data from bioassays). new regulatory actions. However, for many substances, There is already clear evidence from recent research studies there are no—or only insufficient—monitoring data. New of the added value of effects based tools, e.g., in the assess - analytical techniques such as NTS are likely to gener- ment of estrogenicity [78–80]. In the future, the range of ate much more chemical monitoring data in the future. endpoints should be broadened to enable wider application A wider picture of contaminants in the environment will in monitoring. This should involve a systematic approach become a challenge for environmental legislation, e.g., for grouping of chemicals in accordance with their mode the WFD and chemical legislation such as REACH and of action, use sector, etc., as the ‘individual substance’ regu- the overarching Commission’s 2018 Strategy for a non- lation is not efficient enough. While the potential benefits toxic environment [15]. of innovative tools and new risk assessment strategies are NORMAN is establishing collaborations with EU beyond question, it is essential to further develop the oper- regulatory bodies, e.g., ECHA. A reliable assessment of ational applicability of these tools for water management chemicals of emerging concern in environmental media routine. Activities organized by NORMAN have already requires exposure data to be linked with information on proven to be effective in laying the ground for the imple - marketed substances. Following this line, it is impor- mentation of new strategies into policy. tant to establish a mutual data exchange between NOR- So far, NORMAN has been strongly involved in issues MAN databases and IPCHEM. Some of the data that related to chemicals of emerging concern in the freshwa- have been generated (e.g., produced by research studies) ter cycle and the associated EU policies. NORMAN has are still kept in databases with restricted access, so that recently extended its scope with the establishment of a they cannot be used for assessment of occurrence levels. new working group on CECs in the indoor environment. For data produced with public funds, there should be a Likewise, there is the potential for new working groups mechanism to make them available to the public authori- for CECs in the marine or the terrestrial environment. ties and institutional bodies by default. Furthermore, the Furthermore, there are new incentives for the integrated example of per- and polyfluorinated alkyl substances assessment and management of chemicals in the envi- (PFAS) indicates the need to look beyond the list of reg- ronment and human populations. Recently, the European istered substances: only 5% of PFAS have a CAS Registry Commission launched the human biomonitoring project Number as a unique, unmistakable identifier for chemi - HBM4EU. NORMAN has the potential to support inte- cal substances. Novel analytical techniques such as NTS grated approaches for CECs and provide data and knowl- can identify the presence of these compounds in the edge for environmental contaminants to be candidate environment. substances for research in human biomonitoring. Dulio et al. Environ Sci Eur (2018) 30:5 Page 11 of 13 drinking water purification effort; EC: European Commission; ECHA: European Finally, a global economy results in worldwide exposure Chemicals Agency; EDA: effect ‑ directed analysis; EEA: European Environment to chemical stressors, including CECs. Other countries Agency; EQS: environmental quality standard; ICPDR: International Commis‑ beyond Europe are interested in the NORMAN activi- sion for the Protection of the Danube River; IPCHEM: European Information Platform for Chemical Monitoring; JDS: Joint Danube Survey; LOQ: limit of ties and Canadian institutions are already partners of the quantification; MSFD: Marine Strategy Framework Directive; NTS: non‑target network. Sooner or later, the extension to other regions screening; PBT: persistent bioaccumulable and toxic; PFAS: polyfluorinated is likely to become an issue for the NORMAN network. alkyl substances; PMOC: persistent and mobile organic compounds; PNEC: predicted no‑ effect concentrations; RBSPs: River Basin‑Specific Pollutants; SVHC: substances of very high concern; REACH: European Regulation on Conclusions Registration, Evaluation, Authorisation and Restriction of Chemicals; UBA: After 10  years of activities, NORMAN has become an Umweltbundesamt (German Federal Environment Agency); WFD: Water Framework Directive. essential network in support of EU policies. NORMAN integrates EU-wide activities on CECs and facilitates the Authors’ contributions transfer of the state-of-the-art scientific knowledge to VD and JK wrote the first draft of the manuscript. All authors read and approved the final manuscript. policy makers and regulatory bodies. Contaminants of emerging concerns are clearly on the Author details EU water policy agenda, e.g., the WFD, and they are also INERIS, National Institute for Environment and Industrial Risks, Verneuil‑en‑Halatte, France. NIVA, Norwegian Institute for Water Research, an important issue of chemicals policy, e.g., the legisla- Oslo, Norway. IVL, Swedish Environmental Research Institute, Stockholm, tion for marketing of plant protection products, biocides, Sweden. Wageningen Environmental Research, Wageningen, The Nether‑ 5 6 and pharmaceuticals. Prioritizing chemicals in the envi- lands. Eawag, Dübendorf, Switzerland. NILU, Norwegian Institute for Air 7 8 Research, Kjeller, Norway. Environmental Institute, Kos, Slovakia. UBA, ronment for regulation is an increasingly important issue. Federal Environment Agency, Dessau‑Roßlau, Germany. Progress in analytical chemistry and increasing moni- toring activities reveal the occurrence of a large number Acknowledgements We would like to acknowledge the very valuable contributions of the invited of chemical substances in the environment. It is, there- experts from stakeholder and institutional bodies who participated in the fore, necessary to complement the traditional approach NORMAN 10th Anniversary workshop in Brussels on 26 October 2016 and for risk assessment with new tools. NORMAN encour- activities of all members of the NORMAN Association in the past decade. ages the development of collaborative R&D strategies Competing interests with a view to their integration into policy. However, The authors declare that they have no competing interests. new techniques and new monitoring approaches need Availability of data and materials to prove that they can be used in regulatory routine pro- Not applicable. grams and that they are cost-efficient. As a collaborative and multidisciplinary platform, NORMAN fosters the Consent for publication Not applicable. exchange of information, validation, and harmonization work and helps the achievement of consensus within the Ethics approval and consent to participate wider international community on the implementation of Not applicable. the research results into policy. Funding The environmental and human exposure to chemicals Not applicable. of emerging concern need to be assessed in a compre- hensive way, taking into account all environmental com- Publisher’s Note partments and the impact on human health. Springer Nature remains neutral with regard to jurisdictional claims in pub‑ lished maps and institutional affiliations. Without the enormous commitment, efforts, and in- kind contributions of the NORMAN members, the NOR- Received: 25 October 2017 Accepted: 22 January 2018 MAN success stories would not have been possible. 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Published: Feb 22, 2018

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