Baltic Sea Pharma Platform (BSR Pharma)

Poll on BSR Pharma activities in 2024

Baltic Sea Pharma Platform (BSR Pharma) aims to disseminate current knowledge and information on pharmaceuticals in the environment, focusing on effective ways to address this issue. BSR Pharma has been run by the Finnish Environment Institute for almost three years, continuing the groundbreaking work of the Swedish Environment Protection Agency.

Coordinating the BSR Pharma is a delight, yet it remains a continual challenge due to resource constraints. Thus, to ensure we use our resources optimally, we would like to leverage the expertise of the existing network to identify focus points for the BSR Pharma for the future. To develop the platform towards the needs in the field, we created a short (10‒15 min) poll. In this poll, we ask your interests and wishes towards the BSR Pharma.

One of the preliminary aims for 2024 is to organize a roundtable discussion between key stakeholders and sectoral agencies on the EU level. To help us elaborate on this plan, we have included in the questionnaire a couple of more specific questions about a roundtable discussion with relevant EU authorities, which BSR Pharma and PA Hazards are planning to arrange in 2024. The aim of the roundtable is to facilitate the knowledge sharing between authorities, focusing on the needs from the field.

Since only a limited number of people can join the roundtable discussions, we plan to arrange a preparatory workshop or webinar, where we wish to hear the latest developments in the field that we can share to the EU authorities as well as your needs and wishes for the roundtable discussion topics.

Additionally, we would like to hear what are the best ways to share the outcomes of the roundtable meeting to a wider audience.

Please, take this short poll and help us plan the activities for this year! We appreciate all responses submitted by Friday, February 16th. 

Wishing you health and peace on the new journey around the sun,
The BSR Pharma team
Lauri Äystö & Noora Perkola 

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PharmaSea: Which are the environmentally hazardous pharmaceuticals in the Baltic Sea?

Author: Daniel Malnes, Project Researcher, PharmaSea, daniel.malnes(at)helcom.fi

Pharmaceuticals have recently been detected in the Baltic Sea environment. As several countries share the Baltic Sea, cooperation is needed to answer important questions: What is the status of current knowledge, and what needs further investigations?

The initiation of a new HELCOM project
In a new project PharmaSea, HELCOM in collaboration with Contracting Parties will answer important questions related to the Baltic Sea environment. Through the collection of environmental occurrence data, sales data, and evidence of environmentally hazardous properties in the Baltic Sea, the work aims to summarise the findings at the end of 2024. Some preliminary insights are however already available.

Which data is available?
Several countries around the Baltic Sea have provided environmental occurrence data for pharmaceuticals (Figure 1). This data spans several important environmental matrices: different types of waters (wastewater, surface waters collected from rivers, lakes and coasts, as well as marine waters), sediments, and biota. These matrices will provide important information about national usage (wastewaters), environmental fate processes (rivers, lakes, coastal waters and sediments), and the pharmaceuticals ultimately reaching the Baltic Sea (marine waters and marine biota).

An estimated 250 pharmaceuticals, metabolites and transformation products have been monitored across all monitored environmental matrices. The most monitored pharmaceuticals (Figure 2) are typically the pharmaceuticals on the European Union’s Water Framework Directive Watch list and the ones commonly detected in environmental matrices. Dependent on their occurrence in the Baltic Sea environment, environmentally hazardous properties will be evaluated. The evaluation could include (i) environmental persistence, (ii) comparison against concentrations which are chronically toxic for aquatic fauna, (iii) bioaccumulative properties of the contaminants, and potentially more.

The project PharmaSea further aims to collect sales data during 2024 to identify data gaps in, and potentially complement, the environmental monitoring data in the Baltic Sea region. Pharmaceutical usage can differ from country to country, which is why the project aims to identify the priority pharmaceuticals for the Baltic Sea environment. With this approach the ambition is to counter feedback loops where the same contaminants are monitored continuously, potentially missing other hazardous contaminants. The results of the work will be summarised in a report by the end of 2024. 

More information on PharmaSea website (helcom.fi)

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Interreg BSR Project APRIORA – prioritizing pharmaceutical emission sources and receiving rivers by an improved risk-assessment approach

Authors:
Jens Tränckner, University of Rostock, jens.traenckner(at)uni-rostock.de
Alena Seidenfaden, University of Rostock, alena.seidenfaden(at)uni-rostock.de

In November, the new Interreg Baltic Sea Region (BSR) project APRIORA was kicked off in Rostock, Germany. Nine partners in the BSR unite to tackle a huge need: Transfer knowledge and tools regarding pharmaceuticals in the environment to authorities in charge of prioritising emission sources. Why is this a specific challenge?

Broad knowledge on pharmaceuticals in the environment
As stated in HELCOM reports, it is well known that emitted active pharmaceutical ingredients (API) from point sources are posing a long-term risk to the BSR, both in the river catchments and the Baltic Sea. The highest amount of human pharmaceuticals is discharged by domestic wastewater treatment plants (WWTP).

Already, many successful forerunner projects, focussed on pharmaceuticals in the environment, have studied, monitored, modelled and produced a lot of data and created a broad knowledge on the subject.  The projects “CWPharma” and “MORPHEUS” worked with project specific foci on monitoring, modelling and risk assessment approaches, while the projects “Less is More” and “BONUS Cleanwater” developed pilots of technical mitigation measures. Most participating organisations excel in research or transnational political procedures. While authorities overseeing river (sub-) catchments have been involved in previous projects, many lack the full capacity to perform detailed API risk assessments independently. So far, there does not exist a widely established risk assessment framework for APIs in WWTP recipients within the BSR catchment.

Upcoming challenge for authorities in charge – the new UWWTD
Currently, the new revision of the European Urban Wastewater Treatment Directive (UWWTD) strongly fosters the implementation of targeted mitigation measures to reduce the emission of micropollutants, including APIs. (Read more about the UWWTD  in BSR pharma newsletter I/2023). According to the proposal published in autumn 2022, all larger WWTPs (exceeding 100,000 PE (population equivalent)) shall be equipped with advanced treatment for organic micropollutants. Further, a risk-based prioritisation of advanced treatment will be required from all WWTPs between 10,000 and 100,000 PE.

These smaller WWTPs are highly characteristic for the Baltic Sea Region. In the BSR there are  more than 1,000 WWTPs in the range of 10,000 to 100,000 PE, and more than 80% of them are located inland and in rural areas. There is one thing missing in the regulation altogether: the fact that there exist about ten times more WWTPs under 10,000 PE. These WWTPs often have low treatment. Furthermore, they often discharge in small and highly vulnerable surface waters where even small local emissions may have relevant impact on water quality.

It is not affordable to equip all WWTPs with advanced treatment, but a consistent mitigation strategy requires considering all emission point sources, the respective receiving water systems as well as various risks, following the WHO “one health” approach. However, monitoring of APIs and flow is limited and it provides mostly only local, transient insights. The corresponding assessment of environmental and human-related risks is still pending, too. All in all, the authorities in charge will face a huge challenge implementing the ambitious objectives of the new UWWTD.

What is APRIORA and its strategy?
Project partners from Sweden, Poland, Latvia, Finland and Germany are now combining their competencies in the APRIORA consortium (see Table 1). The nine partners have already worked together in previous forerunner API projects. So far, 19 associated organisations support the consortium. Most of the associated organisations are authorities in charge, but there are also wastewater organisations and WWTP operators active in the pilot areas in the five BSR countries involved.

The full title of the project summarises its main objective: “Improved risk assessment for strategic water management to reduce micro-pollutant emissions in the Baltic Sea Region”. This shall be achieved by a spatial high resolution estimation of pharmaceutical emissions and API concentrations in the ambient water system, combined by an integrated risk assessment approach. The development and transfer of such approach can only be successful when accompanied by good communication with the target groups. For the project to fully integrate the needs of the target groups and for the target groups to adapt the outcomes, the project reaches out to the stakeholders and intended applicants at an early stage of the implementation.

General Concept – more details on APRIORA approach
Fortunately, APRIORA does not start from scratch but can build on the above-mentioned forerunner projects in the Baltic Sea Region and research worldwide. However, the APRIORA approach is unique in its clear focus on a holistic concept for impact assessment and prioritisation of emission sources and mitigation measures.

The basic idea is to estimate individual WWTP discharges and related API concentrations in receiving river sections by combining statistical consumption data with WWTP, hydrological data and a simplified calculation of transport at the surface water system. These will feed the subsequent risk assessment, categorized in three different criteria: i) impact on aquatic environment, ii) formation of antimicrobial resistances, iii) hazards to downstream water usage and human health. The approach shall also provide functions to pre-assess the efficacy of technical mitigation measures at individual WWTP. To ease the application of the developed framework by the authorities and operators, APRIORA will provide supporting digital tools implemented in daily-work environment, namely GIS.

Calibration and uncertainty assessment of the simplified emission and transport model is mandatory for a reliable application. This requires targeted monitoring concepts with a condensed list of characteristic and well detectable parameters and wisely chosen locations for sampling and flow measurement. Therefore, designing according monitoring concepts is one crucial part at the beginning of the project. The whole concept depends strongly on the efficient management and processing of geo-data.

The APRIORA´s concept is challenging not only for its developers but also for the target groups. Therefore, an initial capacity building is mandatory. Accordingly, the APRIORA team will establish a digital learning platform with background information and step-by-step tutorials, supplemented by hands-on trainings for different topics. Already at the very beginning, authorities in charge are interviewed to fit the training concepts to their current needs which are expected to be at different levels in each BSR country.

Project Timeline & Call for interested target groups in BSR
The different modules of the framework will be developed in parallel working groups, coordinated by a compact steering group. During the first project year, the concepts are elaborated and accompanied with solid background documentations and pilots are prepared. In project year two, the developed framework and the supporting GIS-tools shall be piloted in five exemplary river basins, one in each country. The third project year will be a year of intense capacity building for the project partners and associated organizations as the knowledge obtained will be rolled-out to the Baltic Sea Region.

The APRIORA outcomes will improve knowledge of cost-efficient mitigation measures. The outcomes are likely to benefit both the authorities in charge and WWTP operators. The APRIORA approach could prove applicable not only to APIs but also to other hazardous compounds and mitigation techniques at wastewater treatment. The APRIORA project also targets in cooperation and fruitful exchange with other Interreg research projects, such as EMPEREST and AdVIQWater.

APRIORA questionnaire awaits your response
Currently, the project reaches out to target groups with an online questionnaire on API monitoring practices in BSR. Expert knowledge at national, regional, and local levels will be collected and analysed to identify best practices. This approach ensures that target groups are involved from the outset to define the initial situation and needs. Anyone working in a related field is welcome to contribute actively! Please submit responses to the survey by February 9, 2024.

If this article has gained your interest either as authority in charge, WWTP operator, research project partner or in any other role, the APRIORA team is happy to get in contact with you and your organisation.

Contact APRIORA: 
APRIORA Project manager, Communication manager:
Alena Seidenfaden, 
University of Rostock,
alena.seidenfaden(at)uni-rostock.de

More information on APRIORA website. (interreg-baltic.eu)

References: 

• European Commission 2022a. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning urban wastewater treatment (recast). Brussels, 26.10.2022, COM(2022) 541 final. 2022/0345 (COD). (europa.eu)

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New PharGTrans project examines whether changes in EU chemicals policy and legislation that support the green transformation affect the pharmaceutical sector

Author: Mirella Miettinen, University of Eastern Finland, mirella.miettinen(at)uef.fi

‘Green transformation’ is an ambiguous concept, but the general idea is to move towards sustainability to combat global environmental change caused by human activities. The European Union (EU) has a large pharmaceutical market and a competitive pharmaceutical industry. However, the shift to a greener design and production of pharmaceuticals will require transformation by many pharmaceutical actors in the EU.

The need for empirical studies
There are few empirical studies on how different actors operationalise transformation in practice. In addition, the cross-cutting effects of policies and legislation, such as the European Green Deal and the resulting changes to EU chemicals legislation, have not yet received much attention in the pharmaceutical sector.

The four-year PharGTrans project, funded by the Research Council of Finland, explores how changes in EU chemicals policy and legislation may affect green transformations in the pharmaceutical sector in the EU. The project will conduct an interview study among various stakeholders in the pharmaceutical sector to gather new qualitative data on the perceptions and drivers of green transformation. The stakeholder groups interviewed will cover researchers, industry, interest groups, public authorities, and political decision-makers.

Four universities are involved
The project is led by Senior Researcher and Academy Research Fellow, Docent Mirella Miettinen at the University of Eastern Finland Law School. The project partners include the Universities of Eastern Finland, Helsinki, Stockholm and Aarhus representing law, pharmacy and environmental sciences. Pharma Industry Finland (PIF) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are also collaborators in the project.

The research is grounded on an interdisciplinary collaboration between researchers in environmental law, pharmacy, and environmental science. One of the project goals is to establish a network of researchers that brings together expertise in law, pharmacy and environmental sciences and provides training for young researchers.

The project is a continuation of the SUDDEN project
PharGTrans is a continuation of the SUDDEN project, which was funded by the Strategic Research Council at the Research Council of Finland in 2018–2023. SUDDEN focused on the environmental impacts associated with the life cycle of pharmaceuticals, with a second objective of enhancing the sustainability of the pharmaceutical sector.

The legal work carried out in SUDDEN examined the relevant regulatory frameworks at international, EU and national level. One of the overarching findings was that the pharmaceutical industry is under increasing regulatory pressure to address sustainability and environmental concerns, particularly at EU level.

Results help to support transformation paths both in practice and in policy making
PharGTrans’s analysis of policy and legal documents and interviews focus in particular on the design and manufacturing stages of the pharmaceutical life cycle. The empirical findings will be combined with the scholarly literature on green transformation in order to synthesise insights on the depth and triggers of green transformation pathways in the pharmaceutical sector and to provide recommendations on how to support this transformation in practice and in policy making.

More information on PharGTrans project website (uef.fi)

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Do you have something you would like to share to the BSR PHARMA?
Tips on contents for future newsletters are welcomed at BalticPharma(at)syke.fi

EU legislation to reduce the risk of pharmaceuticals in the environment

Authors: 
Lauri Äystö, Finnish Environment Institute, lauri.aysto(at)syke.fi;
Noora Perkola, Finnish Environment Institute, noora.perkola(at)syke.fi

In late October 2022, the European Commission (EC) proposed updates for the urban wastewater treatment directive (EC 2022a) and other water directives (EC 2022b), including the environmental quality standards directive. In both proposals, the level of ambition concerning micropollutants, including active pharmaceutical ingredients (APIs), has increased drastically.

The proposed updates
The directive updates cover everything from wastewaters to surface waters and onto groundwaters, also touching upon greenhouse gas emissions, public health information (e.g. about epidemics) and the circular economy, among other things. The proposed updates are numerous and, in some cases, fundamental.

While the list of monitored parameters in the urban wastewater treatment directive (91/271/EC, UWWTD) previously largely focused on nutrients, the proposal (EC 2022a) requires member states to monitor water framework directive (WFD) priority substances, selected indicator micropollutants, microplastics and antimicrobial resistance, among other things. Moreover, the list of WFD priority substances (EC 2022b) is proposed to be modified, including the addition of 10 APIs as priority substances for surface waters (see Table 1). Additionally, two APIs (carbamazepine and sulfamethoxazole) are proposed as priority substances for groundwaters.

If the proposed updates are accepted, this would be the first time that APIs have received legally binding environmental quality standards in the EU. Furthermore, as priority substances, these APIs would be included in the list of monitored substances in the UWWTD.

Enhanced micropollutant removal
In addition to increased requirements for monitoring, the UWWTD requires quaternary treatment, capable of removing a wide range of micropollutants, to be implemented in a stepwise manner. By 2035 all wastewater treatment plants (WWTPs) with a population equivalent (PE) exceeding 100,000 should have implemented these technologies. Furthermore, WWTPs exceeding 10,000 PE are required to implement similar technologies by 2040 unless the absence of risks to human health and the environment can be demonstrated. This last-mentioned requirement only applies to WWTPs releasing their effluent wastewater to specific types of recipients. While the list of relevant recipients is extensive, it excludes coastal waters that are not used for aquaculture or bathing and where wastewater gets diluted more than tenfold.

Who is going to pay?
The increased costs to WWTPs caused by the monitoring and treatment requirements are proposed to be covered by an extended producer responsibility (EPR) scheme. According to the proposal’s (EC 2022a) background documents, the toxic load reaching the WWTPs mainly originates from pharmaceuticals and personal care products. Thus, the EPR is proposed to only be applied to the pharmaceutical and cosmetic industries.

Has the problem of pharmaceuticals in the environment been solved?
Some parts of the directive proposals would benefit from more concrete definitions. These include, for example, the sum parameter for APIs and their transformation products set for groundwater quality standards, where the maximum allowed limits of quantification and a priority list of the parameters to be included in the analyses should be set. Furthermore, the risk assessments required in the UWWTD needs to be defined with standard procedures. Nevertheless, the proposals are a welcome signal that the work carried out so far in the field of pharmaceuticals in the environment will eventually materialise into EU-level regulation. Moreover, according to EC 2022c, the micropollutant load on the environment is expected to decrease by circa 30% by the year 2040 when implementing the proposed UWWTD. This is a significant fraction, but it still leaves researchers working in the field with some work to do.

References

• European Commission 2022a. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning urban wastewater treatment (recast). Brussels, 26.10.2022, COM(2022) 541 final. 2022/0345 (COD) (europa.eu) 
• European Commission 2022b. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2000/60/EC establishing a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the field of water policy. Brussels, 26.10.2022, COM(2022) 540 final. 2022/0344 (COD) (europa.eu)
• European Commission 2022c. COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Directive of the European Parliament and of the Council concerning urban wastewater treatment (recast). Brussels, 26.10.2022, SWD(2022) 541 final (europa.eu) 

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Creating new incentives for the responsible manufacturing of antibiotic

Author: Radhika Gupta, Project Communications Manager, SIWI, radhika.gupta(at)siwi.org

The Responsible Antibiotics Manufacturing Platform (RAMP) is operating to create new incentives based on criteria that define responsible manufacturing.

The release of antibiotics from manufacturing waste streams into the environment poses global health and business risks. Yet, it remains a challenge to bring about change for two reasons. First, there is a lack of jointly defined objectives and access to verified information that shows progress towards reduction in antimicrobial resistance. Second, there is a lack of enabling conditions that would incentivise and drive demand for improved industry practice.

In an interview with Nicolai Schaaf (‘NS’ in the interview below), Team Lead for Water and Pharmaceuticals, and Iris Panorel (‘IP’ in the interview below), Programme Manager at the Stockholm International Water Institute, we discuss RAMP’s newly developed framework, a work in progress.

What is the role of water governance in reducing the risk of the spread of antimicrobial resistance?
IP: Water is central to reducing the risk of the spread of antimicrobial resistance (AMR). Access to clean water and sanitation is the most basic step in protecting human health from pathogenic diseases and reducing the use of antibiotics. On the other hand, contaminated water sources can act as hotspots and vectors of resistant genes and pathogens.

When it comes to the challenge of AMR, it arises from the lack of collective action by responsible stakeholders. As water plays a central role in addressing this challenge, at SIWI [the Stockholm International Water Institute] we see the need for global water governance and the need to prioritise both the development of policies and their implementation.

NS: The main problem in the space of pharmaceuticals and antibiotics in the environment is that there are no science-based standards. This means that all the engaged stakeholders are pioneering and covering new ground, without a harmonised outcome. Approaching the challenge from a water governance perspective can help to create the right structures.

What is the challenge that RAMP is trying to solve?
IP: Most antibiotics that enter the environment and significantly drive AMR come from usage (by humans and animals) and from the improper disposal of medical waste or unused medicines. RAMP wants to address localised water pollution resulting from the manufacturing of antibiotics, which is a preventable driver. Specifically, it wants to address the exposure of bacteria to selective concentrations that trigger AMR.

Currently, there is a lack of consensus on what responsible antibiotics manufacturing across the value chain should be. RAMP’s goal in this framework is to synthesise and connect the roles and needs of different stakeholders in order to promote policy changes and create enabling conditions for improved industry practice.

More concretely, how is RAMP engaging with the stakeholders?
NS: The character of our work is that we help stakeholders to understand their individual roles and responsibilities, which form part of a larger picture to combat AMR. No one can solve this challenge alone.

There is a critical need to understand that the physical implementation of good practice takes place at the factory level. But in the absence of independent standards, we need to define what needs to be done and how it is going to be implemented, and RAMP is facilitating this dialogue with the industry, solution providers, regulators and scientists.

IP: RAMP has prepared a framework that will take into account the different perspectives of relevant stakeholders from the supply-and-demand side of the antibiotic manufacturing chain. This is an attempt to define and harmonise criteria for responsible antibiotics manufacturing that is scientifically backed and fits the purpose of preventing the risk of AMR.

Our proposal for independent criteria is currently undergoing consultation with scientists, UN agencies, procurers and industry.

What are the key features of the framework?
NS: Inspired by the environmental regulation of the Industry Emissions Directive and the Indian Zero Liquid Discharge policy, the framework recommends building a standard based on targeted interventions and the best available technologies, in addition to the established method of measuring concentrations of APIs [active pharmaceutical ingredients].

The framework finds a balance between the core objective of safe discharge limits and environmental concentrations, and technical achievability and verifiability.

What do you hope to achieve with this framework, and who is it intended for?
IP: The framework is created to help procurers integrate verifiable environmental aspects into their sustainable procurement tools. By taking this concrete requirement into account in their tenders, they can incentivise those companies in the supply chain that are capable of demonstrating good manufacturing practices for antibiotics.

NS: The criteria of the framework will be the connectors between the required physical improvements in manufacturing and how policy and market instruments – including public procurement – can utilise this approach for sustainability criteria.

How will the framework be applicable in the context of Baltic Sea countries?
NS: We want to empower governments and agencies to live up to their responsibility regarding preventing pollution. As the manufacturing of antibiotics is limited in the region, the impact here is rather found in preventing emissions from other parts of the world. We believe that the logic of achieving safe discharge levels and that the means of implementation and verification are applicable to various sources of antibiotics and other pharmaceuticals. This could help in defining guidance for discharge levels or interventions in healthcare facilities, food production and municipal wastewater treatment systems.

About SIWI
SIWI engages with a broad range of water-related topics and has a focus on building stronger societies by improving water governance.

RAMP was launched in 2020. It builds on SIWI’s past work with pharmaceutical industries that target reduction in the spread of AMR.

More information on SIWI webpage. (siwi.org)

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Researchers from Lithuania and Latvia are obtaining new knowledge on the pharmaceutical pollution of wastewaters and water bodies in both countries

Authors:
Sergej Suzdalev, Marine Research Institute, Klaipeda University, sergej.suzdalev(at)apc.ku.lt;
Michael Stapf, KWB – Berlin Centre of Competence for Water, michaelstapf(at)gmx.net

Although significant efforts have been devoted to the water pollution reduction in both Latvia and Lithuania, and although a substantial decrease in urban pollution has been achieved, a report on pharmaceuticals occurrence in the Baltic Sea that was published in 2017 (UNESCO & HELCOM 2017) indicated major data gaps in Lithuania and Latvia related to sources and pathways, including gaps on the sales and consumption of pharmaceuticals and their concentrations in freshwater and wastewater systems (river water, and influents and effluents of municipal wastewater treatment plants (WWTPs)).

Since February 2021, researchers of the Marine Research Institute of Klaipėda University have cooperated closely with the Latvian Institute of Aquatic Ecology of Daugavpils University and the Latvian Environment, Geology and Meteorology Centre – as well as with other national public and regional institutions – aiming to obtain the lacking knowledge on and experience of pharmaceutical pollution loads and their effects on the environment in order to support the future prioritisation and development of policy measures for the implementation of pharmaceutical pollution mitigation in Latvian and Lithuanian waters (MEDWwater – Pharmaceuticals in wastewaters – levels, impacts and reduction, LLI-527).

Twenty-five pharmaceutical substances investigated in 16 selected places
Based on the agreed criteria, 16 relevant WWTPs and water bodies (eight from Lithuania and eight from Latvia) were selected for further detailed investigations within the MEDWwater initiative. Two sampling campaigns were conducted: in the 2021 summer period (July–August) and winter period (December). Sixty-seven samples of wastewater and 65 samples of water from the selected waterbodies/receivers were collected in both countries during both sampling campaigns and sent to Klaipėda University’s Marine Research Institute for sample preparation and analysis of the 25 selected pharmaceuticals, representing different therapeutic groups.

The apparent domination of anti-inflammatory and analgesic substances in the wastewaters
The measured concentrations of active pharmaceutical ingredients (APIs) in the WWTP influents varied over several orders of magnitude (ranging from 10 ng/L to 40,000 ng/L) with the highest values typically being for diclofenac, ibuprofen, paracetamol (non-steroidal anti-inflammatory drugs and analgesics), metoprolol (a beta blocker) and oseltamavir (an antiviral medication). A comparison of the median API concentrations in the WWTP influent of both countries showed that most APIs were in a similar range. For five APIs (aciclovir, hydroxychloroquine, ibuprofen, oseltamavir and paracetamol), the median concentrations were more than twice as high in the Lithuanian WWTPs compared with the Latvian WWTPs.

The patterns of the API concentrations in the WWTP effluent were similar to the ones in the WWTP influent, but they had been reduced by about 40–60 %. Only diclofenac and paracetamol were still detected in the WWTP effluent in concentrations above 1,000 ng/L, whereas the majority of the APIs at the Latvian WWTPs had a median concentration of <100 ng/L.

There was a general tendency that the highest concentrations of APIs were detected in the influents and effluents of the largest WWTPs: those at Daugavpils and Liepāja in Latvia and Klaipeda, Šiauliai and Telšiai in Lithuania.

The concentrations of ibuprofen in the receiving water bodies posing an environmental risk
Although no legally binding environmental quality standards (EQSs) are available for the APIs measured in the MEDWwater project, predicted no-effect concentration values from the available scientific studies have been used to calculate risk quotients based on the average API concentrations in water samples taken downstream of the investigated WWTPs. In the receiving water bodies, only the biodegradable ibuprofen had concentrations above its proposed EQS (10 ng/L) at the sampling point and, thus, could cause an environmental risk if the annual average concentration was at this level.

The readiness of Lithuanian and Latvian WWTPs to implement advanced treatment technologies
In order to fill the knowledge gap and get examples of WWTPs optimisation options – seeking to improve the removal rates of pharmaceuticals during the treatment process – a foreign expert (Dipl.-Ing. Michael Stapf) from Kompetenzzentrum Wasser Berlin (KWB) has been outsourced to deliver technical consultation for the selected WWTPs. Based on the available data for the 16 selected WWTPs in Latvia and Lithuania, it was concluded that most of the investigated WWTPs are not suitable for a powdered activated carbon treatment because of the manner of their current excess sludge disposal. Due to the lack of information on bromide and nitrite concentrations, it is currently not possible to assess the suitability of ozonation. There are no obvious barriers to the implementation of a granulated activated carbon filtration. At the moment, most of the investigated WWTPs do not have an existing tertiary treatment stage that can be used in combination with API elimination technologies (e.g. ozonation post-treatment).

(This publication has been produced with the financial assistance of the European Union. The contents of this publication are the sole responsibility of Project Partners and can under no circumstances be regarded as reflecting the position of the European Union.)

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The Finnish environmental classification of medicines offers information about the risks medicines pose to aquatic environments

Author: Elli Leppä, Development Pharmacist (PhD), Pharmaca Health Intelligence, elli.leppa(at)pharmaca.fi

Health care professionals, like doctors and pharmacists, face increasing numbers of patient and customer questions concerning the environmental effects of medicines. In Sweden the FASS environmental classification has been used for over 15 years to convey information about the risks of medicine residues in aquatic bodies. In Finland there was no similar classification until December 2021, when Pharmaca Health Intelligence published the Finnish environmental classification for health care professionals.

Most consumers and many health care professionals are unaware that appropriately used medicines currently have the heaviest impact on the environment. A common misconception is that, if unused, medicines are disposed of responsibly and the environmental impact of medicine use approaches zero. To reduce the environmental load from medicines, more attention should already be paid when choosing treatments in addition to paying attention to the disposal phase of the medication process. To reduce the effects on, for example, aquatic environments, the abundant research data concerning medicines in the environment has to be formulated into clear, user-friendly tools in order to help health care professionals in choosing the least environmentally harmful medicines in situations when such choices are possible to make.

Rational drug therapy should focus on the patient’s needs and promote the use of the necessary medicines. Care should be taken that medicine information does not cause any undue concern for the medicine’s users (e.g. regarding the environmental safety of the medicine). However, in situations where several therapeutically equivalent options are available to treat the patient’s disease or symptoms, clear and concise information about the environmental effects of medicines may be one of the selection criteria that health care professionals can use to choose the most suitable option.

In a small study about the needs of pharmacy professionals for environmental information about medicines (Minkkinen et al., 2020), 68% of the respondents (pharmacists currently working in pharmacies) reported that finding information about the environmental effects of medicines was difficult or very difficult. The great majority (83%) of the respondents thought that a Finnish environmental classification should be created to support the information needs of health care professionals. In December 2021 Pharmaca Health Intelligence (previously the Pharmaceutical Information Centre) published the Finnish environmental classification of medicines as a part of the Pharmaca Fennica compendium of medicine information for health care professionals. The classification is based on the Swedish FASS classification (www.fass.se) and includes information about the risk class, bioaccumulation and degradation profiles of medicines.

The environmental classification is substance based and covers medicines for human use. The risk class is presented both as text and in symbol format. The risk is divided into five classes, with additional degradation and bioaccumulation information. The risk level is influenced by both the toxicity (implied by the predicted no-effect concentration (PNEC)) of the medicine and the extent of exposure (the predicted environmental concentration (PEC)). The total sales of the substances in Finland are used to calculate the amount of exposure. Substance groups which are known to have little to no environmental effects (e.g. vitamins, proteins) have been placed in the lowest (‘no effect’) class.

Further reading:

• Minkkinen L. et al.: Lääkkeiden kansallinen ympäristöluokitus – millaista tietoa apteekeissa tarvitaan lääkkeiden ympäristövaikutuksista? (Dosis 3/2020) 
• Miljöinformation i Fass (fass.se)

Upgrading of Swedish wastewater treatment plants – research and practice hand in hand

Author: Michael Cimbritz, Department of Chemical Engineering, Lund University, michael.cimbritz(at)chemeng.lth.se

The Swedish Environmental Protection Agency is distributing grants until 2023 for measures that improve the water environment in seas, lakes and waterways. Municipalities have been given the opportunity to apply for funds for pre-studies and investments in advanced wastewater treatments to remove pharmaceuticals and other organic micropollutants. This has led to the upgrading of several full-scale facilities in Sweden. Behind the expansions lies extensive research and development work, for example within the framework of a project coordinated by Lund University and financed by Interreg South Baltic.

A national organization for increased knowledge
The contributions of the Environmental Protection Agency should not only lead to concrete measures in the form of full-scale installations, but also contribute to increased knowledge build-up by highlighting issues related to the planning, projecting, procurement, installation and operation of full-scale plants. Therefore, a client/tender group has been formed to promote knowledge exchange between different stakeholders. The overall goal is the cost-effective introduction of efficient and reliable technical solutions, and the group is managed by the Swedish Water and Wastewater Association. Information is disseminated primarily through an annual seminar and through various reports posted on the client group's website.

New facilities and new research
At the time of writing, there are several full-scale plants in operation in Sweden, based on either ozone or granulated activated carbon or both. Some of the facilities are located in Skåne (in Simrishamn, Kivik, S:t Olof and Degeberga). Others are found in Ronneby, Linköping and Tierp and more facilities are in the planning stage. The development can be followed via the client group's website.

There are also several ongoing pilot projects in collaboration between municipalities, universities and research institutes. In Skåne, successful research has been conducted within the framework of the LESS IS MORE project financed by Interreg South Baltic and with members from Sweden (Department of Chemical Engineering at Lund University, Sweden Water Research and Kristianstad University), Lithuania (Kretinga Water), Denmark (Slagelse Utility and Slagelse Municipality) and Poland (Gdansk Water Fund). The project provided opportunities not only for the demonstration of full-scale activated carbon filtration but also for the development of new and exciting methodology for studies of removal mechanisms in various processes for the removal of organic micropollutants.

Radioactive pharmaceuticals to develop future treatment processes
By radioactively labelling different substances we (at the Department of Chemical Engineering at Lund University) have developed a new approach to study interactions in for example ozonation and activated carbon adsorption.

During ozonation, pharmaceuticals and other substances are converted into various transformation products. We know that toxicity is usually lower following ozonation, but there are thousands of substances to keep track of and it is almost impossible to map all reaction pathways and new transformation products. However, with radioactive labelling of wisely selected substances, we can follow important groups of substances through an ozonation process or through a carbon filter.

This means that we for example can investigate whether formed transformation products can be biologically degraded or whether they can be fixed to activated carbon in post-treatment. Such knowledge is a central piece in the design of future processes for the removal of organic micropollutants.

Further reading: 

• Betsholtz, A., Juárez, R., Svahn, O., Davidsson, Å., Cimbritz, M., Falås, P., 2022. Ozonation of 14C-labeled micropollutants – mineralization of labeled moieties and adsorption of transformation products to activated carbon. Water Res. 221. (sciencedirect.dom)

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Finns are willing to pay for a more environmentally friendly pharmaceutical sector

Author: Lasse Alajärvi, University of Eastern Finland, lasse.alajarvi(at)uef.fi

A recent study by the School of Pharmacy at the University of Eastern Finland demonstrates preferences for a more environmentally friendly pharmaceutical sector among Finnish residents. The study shows Finns’ valuations for different aspects of an environmentally friendly pharmaceutical policy and the effect of environmental attitudes on Finns’ valuations.

Although the environmental impact of medicines is a well-known threat to biodiversity, and the users of medicines are the major source of pharmaceuticals in the environment (PiE), the valuations and preferences among the population for the environmental friendliness of the pharmaceutical sector are a rarely studied topic. The valuations of Finnish residents for the environmental friendliness of the pharmaceutical sector were studied by using a discrete choice experiment as a part of a PiE-themed population survey. In the survey, respondents were presented pharmaceutical policy options aimed at reducing the environmental impact of medicines. The policy options consisted of different combinations of attributes: available information on the environmental impacts of medicines, the geographical scope of the policy, time to the implementation of the changes, the concrete environmental impact of the policy, and the annual cost per person. By using the attribute “annual cost per person”, it was possible to measure the respondents’ perceived utility by money and define the willingness to pay (WTP) for the policy.

The respondents considered the concrete environmental impact of the measures, i.e., the reduction in the amount of harmful pharmaceuticals ending up in the environment, as the most important factor of the hypothetical pharmaceutical policy. The second most important factor for the respondents was EU-level policy measures over policy measures covering only Finland or Nordic countries. Access to information on the environmental effects of medicines was ranked as the third most important among the respondents. When generalized to the whole Finnish adult population of 4.5 million residents, the respondents' annual WTP varied from EUR 37 million to EUR 134 million, depending on the policy options. In addition, the willingness to pay depended significantly on the respondent's general environmental attitude. Respondents’ household gross income had no effect on the WTP.

Of the respondents, 39.6% belonged to the most environmentally friendly group, whose willingness to pay was on average over 6 times higher than that of the least environmentally friendly respondents. The least environmentally friendly group included 28.7% of respondents. The most environmentally friendly group included more frequently women, the highly educated, and people over 60 years of age compared to the least environmentally friendly group.

Monetarizing people’s preferences and valuations for a more environmentally friendly pharmaceutical sector helps to assess the population’s perceived value for improvements of environmental friendliness in the pharmaceutical sector. The study results also indicate that improving the general environmental attitudes of the public, for example through education, will also benefit the implementation of environmentally friendly policies in the context of pharmaceuticals.

The survey was conducted as an electronic survey by a Finnish marketing research company Taloustutkimus Oy in December 2019. A total of 2,030 persons 18 to 79 years of age, living in mainland Finland responded to the survey. The study contributes to a multidisciplinary SUDDEN research consortium that aims at reducing the environmental impact of pharmaceuticals and supporting sustainable growth in the pharmaceutical industry. The project is funded by the Strategic Research Council at the Academy of Finland.

Link to the original research article: 

• Alajärvi, L.; Lehtimäki, A.-V.; Timonen, J.; Martikainen, J. Willingness to Pay for Implementation of an Environmentally Friendly Pharmaceutical Policy in Finland—A Discrete Choice Experiment Study. Int. J. Environ. Res. Public Health 2022, 19, 6535. (mdpi.com)

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Now available: updated UBA database – “Pharmaceuticals in the environment”

Author: Arne Hein, Section Pharmaceuticals, German Environment Agency, arne.hein(at)uba.de

Pharmaceutical residues occur globally in the environment. This is demonstrated in the updated database Pharmaceuticals in the environment (PHARMS-UBA) from the German Environment Agency (UBA). The publicly available database contains over 270,000 data entries from over 2,000 publications.

Background
Over the past decades, human consumption of pharmaceuticals has steadily increased. It is known that their growing use is leading to detectable levels in all environmental compartments, potentially causing harm to ecosystems. However, a concise and comprehensive overview of the relevant pharmaceuticals, their concentrations in the environment and their potential effects on human health and ecosystems is still pending. To organize the huge amount of available information resulting from the global environmental exposure situation, ⁠UBA⁠ initiated this database project to collect all these data in a single publicly available database.

The present update includes data collected from publicly available literature published until the end of 2020.

Results
The database contains now 276,895 data entries from 2,062 publications. In total, 992 different active substances and/or their transformation products were measured worldwide in concentrations above the detection limits of the respective analytical methods employed, revealing regional patterns. Most of these substances were found in the effluents of wastewater treatment plants (liquid emission – globally: 771, EU: 591). In surface water, groundwater and drinking water, 703 substances were detected globally and 483 in the EU (liquid emmission).

The measured environmental concentrations (MEC) of human and veterinary pharmaceutical residues were reported worldwide for 61 environmental matrices. The matrices with the most MECs are surface water, groundwater, tap/drinking water, sewage, effluents and sludge of wastewater treatment plants (WWTP), soil, sediments and suspended particulate matter.

The database
The data were transferred from the publications, reports, and other data sources into the MEC database. The database is available for download as a Microsoft Excel© or as Microsoft Access© file. Each database entry comprises 33 fields, including amongst others the name of the pharmaceutical substance, its CAS number, the environmental matrix the substance was measured in, geographical location, sampling period, number of measurements, measured concentration in original and standardised units, detection limit of the analytical method employed, pollution source (if available), literature citation, publication language and type, and quality flag.

All references used are compiled in an Endnote© literature database. For transparency and to allow for better working with the MEC database, please download the literature database as a travelling library and in other formats as a zip-file.

• Download the MEC database (umweltbundesamt.de)
• Download the literature-database and other supporting information (umweltbundesamt.de)
• The PHARMS-UBA database can also be accessed via the IPCHEM Portal. (europa.eu)
  Until now, only database version 2 is available. However, the updated version 3 will be integrated shortly.

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HELCOM indicator on diclofenac

Author: Lauri Äystö, Finnish Environment Institute, lauri.aysto(at)syke.fi

HELCOM indicators are used in assessing the status of the Baltic Sea. The second HELCOM holistic assessment included 12 core indicators on hazardous substances. Diclofenac is the first pharmaceutical with a HELCOM indicator under development.

HELCOM indicators
The core indicators included in the second HELCOM holistic assessment (HOLAS2, HELCOM 2018a) included heavy metals (As, Cd, Hg, Pb), radioactive substances (Cs-137), legacy pollutants (PCBs, PCDD/Fs, PAHs), brominated flame retardants (HBCDD and PBDE), and PFOS. While there are no pharmaceuticals included in the HELCOM core indicators, a pre-core test indicator for diclofenac was published in 2018 (HELCOM 2018b). The indicator proposed utilizing environmental quality standards (EQS) derived for the EU Water Framework directive (2000/60/EC) as threshold values. These EQSs are currently under development. Thus, the threshold values for diclofenac have not yet been agreed to commonly in HELCOM, and the indicator has not yet been fully integrated within HELCOM’s holistic assessments.

Threshold values proposed for diclofenac
The threshold values proposed in the 2018 test indicator (HELCOM 2018b) were 5 ng/l for marine waters and 1 µg/kg w.w. for biota. On the other hand, recently the European Commission (EC 2021) proposed EQSs of 4 ng/l for the annual average concentration in marine water and 1.16 µg/kg w.w. for biota. While the proposed EQS values have been criticized e.g. by Leverett et al. (2021), the preliminary opinion of the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER 2022) supported the EQS values for marine water and biota, as proposed by EC 2021.

Indicator development for HOLAS 3
The indicators will be utilized in the third HELCOM holistic assessment (HOLAS 3), which is to be published in 2023. To produce an up-to-date assessment of the status of the Baltic Sea, the indicators are currently being updated.

Assessing the status of the Baltic Sea related to hazardous substances requires concentration data. In May 2021, HELCOM issued an ad-hoc data call for indicators with no existing reporting routines, such as diclofenac. The data was to cover the years from 2016 through to 2021, and to be reported by the end of May 2022. The data call covered not only surface waters and biota, directly related for the 2018 test-indicator, but also all relevant data on wastewater treatment plants, rivers, and sediments.

The ad hoc data call resulted in a dataset covering altogether circa 3,600 individual measurements. Datapoints on surface waters accounted for over 70% of the data, out of which less than 15% were marine waters.

The EQS values proposed for diclofenac by EC 2021 are proposed to be utilised as HELCOM threshold values in this pre-core indicator for HOLAS 3. To assess the status of the Baltic Sea related to diclofenac, the reported concentrations were aggregated to HELCOM level 4 assessment units and compared to the proposed threshold values.

In the provisional evaluation carried out for marine areas, the reported data shows nine assessment units to achieve good status (i.e. concentrations do not exceed the proposed threshold values). On the other hand, 15 units fail to achieve good status, and the status is uncertain for 24 units. The status was considered uncertain whenever diclofenac was not detected, but the analytical limit exceeded the proposed threshold value.

Next steps
The work and its results are currently part of an ongoing process. The indicator results were submitted to HELCOM contact points in each country for review until 30th September 2022. After the review, the indicator report is to be finalized in October 2022 and final outcomes are expected in March 2023.

Links to references:

• European Commission (EC) (2021) Draft EQS Datasheet: Diclofenac. (europa.eu)
• HELCOM 2018a. State of the Baltic Sea – Second HELCOM holistic assessment 2011–2016. Baltic Sea Environment Proceedings 155. (helcom.fi) 
• HELCOM 2018b. Diclofenac. HELCOM pre-core indicator report. July 2018. (helcom.fi)
• Leverett, D., Merrington, G., Crane, M., Ryan, J., Wilson, I., 2021. Environmental quality standards for diclofenac derived under the European Water Framework Directive: 1. Aquatic organisms. Environ. Sci. Eur. 33.  (springeropen.com)

• SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) 2022. Preliminary Opinion on Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive - diclofenac, 6 May 2022. (europa.eu)

   

New report on micropollutants in BSR wastewater treatment plants

Authors: 
Lauri Äystö, Finnish Environment Institute, lauri.aysto(at)syke.fi
Dmitry Frank-Kamenetsky, HELCOM secretariat, dmitry.frank-kamenetsky(at)helcom.fi

In 2017, the UNESCO & HELCOM status report on pharmaceuticals in the aquatic environment of the Baltic Sea region revealed the presence of several active pharmaceutical ingredients (APIs). A new report, recently approved for publication in the BSEP Series, provides further insight into the problem of contamination of the BSR environment, particularly, emissions of a wide range of micropollutants, including over 100 pharmaceuticals, at wastewater treatment plants within the region.

The most recent HELCOM holistic assessment (HOLAS II) found all parts of the Baltic Sea to be under pressure from contaminant emissions. However, for a long time, HELCOM work has mainly focused on a handful of indicators originating from the list of priority contaminants established more than a decade ago, such as polybrominated diphenyl ethers, polyaromatic hydrocarbons and polychlorinated biphenyls. As a result, several groups of so called micropollutants have previously been largely overlooked in HELCOM work.

In 2015, HELCOM launched a data call on active pharmaceutical ingredients (APIs) in the Baltic Sea environment. This data call resulted in the UNESCO & HELCOM status report, highlighting the widescale presence of these substances in the aquatic environment of the Baltic Sea catchment area. However, following the conclusions of the report, and implementing a HELCOM joint action on micropollutants in wastewater treatment plant (WWTP) effluents, a further data call was launched in 2017. Its aim was to produce a more comprehensive picture of micropollutant emissions within the Baltic Sea region. The data call covered several classes of micropollutants, such as alkylphenols, perfluoroalkylsubstances, heavy metals and pharmaceuticals.

The reported data was processed in a collaborative effort between the HELCOM secretariat and projects BSR-water, CWPharma and BONUS CLEANWATER. For pharmaceuticals, the data produced in the 2015 and 2017 data calls were merged to create the most comprehensive data compilation on API occurrence in WWTPs within the Baltic Sea region. The resulting report was approved for publication in the Baltic Environment Proceedings (HELCOM HOD 61-2021) and will be published early 2022.

Data coverage
The work on pharmaceuticals focused on API emissions from wastewater treatment plants. The dataset on pharmaceuticals consisted of circa 10,000 datapoints, covering over 100 WWTPs and 117 individual substances. While the dataset had a relatively good geographical coverage of seven BSR countries, the countries were not represented uniformly. Data reported from Denmark accounted for over 60% of all datapoints, while Germany and Finland accounted for 16% and 14%, respectively. The remaining 10% of datapoints were reported from Sweden, Estonia, Latvia and Poland. Similarly, sewage sludge as a sampling matrix was underrepresented in the dataset. Sludge samples accounted for only 8% of all samples, while influent and effluent samples accounted for 33% and 59%, respectively.

Pharmaceutical emissions from wastewater treatment plants
The APIs present in the highest median concentrations in effluent wastewater included, among others, the anticonvulsant gabapentin (med 6,800 ng/L, n=17), the contrast agent amidotrizoate (med 4,900 ng/L, n=252), and the diuretic furosemide (med 3,600 ng/L, n=247). Out of these three APIs, only furosemide was also analysed in influent samples. Its concentrations in influent water samples were within the same order of magnitude as in effluents (med 7,200 ng/L, n=184).

While the concentrations of the APIs considered in the EU Water framework directive (2000/60/EC) watchlists were not the ones detected in the highest effluent concentrations, they often exceeded their proposed environmental quality standards (EQS). For instance, 93% of the quantified diclofenac concentrations (med 2,200 ng/L, n=249) in effluent samples exceeded the EQS proposed for the substance. Similarly, azithromycin (med 90 ng/L, n=11) and erythromycin (med 13 ng/L, n=71) exceeded their proposed EQS-values in 91% and 41%, respectively. Also, the hormones 17β-estradiol, 17α-ethinylestradiol and estrone exceeded respective EQSs in a vast majority of quantified samples, sometimes several orders of magnitude. It is also noteworthy, that for these substances the limits of quantification were often higher than the proposed EQS-values.

Way forward
The report leaves no doubt as to whether APIs are present at WWTPs and discharged into the environment. Moreover, the report supports previous observations that there are several APIs that are not removed efficiently in conventional WWTPs.

While the report confirms that APIs are continually leaking into the Baltic Sea environment, the data on API occurrence is still very fragmented. To identify the APIs posing the highest risks to recipient environments, as the first step, comprehensive dataset consisting of a representative number of observations and applying analytical methods of sufficient precision would be needed. This dataset, in combination with relevant ecotoxicological data, could then be utilized to prioritize APIs for establishing regional and national monitoring programmes and to develop measures to reduce their input to the aquatic environment.

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Pharmaceuticals to be included for the first time in WFD priority substance list? 

Author: Jukka Mehtonen, Finnish Environment Institute, jukka.mehtonen(at)syke.fi

The revision of the list of WFD priority substances is going on now and pharmaceuticals are well represented among candidate substances. The EQS dossiers are now being prepared but it takes several years until new priority substances are entered into force at a national level. EU wide water related Watch lists are big steps forward in the risk assessment of contaminants in Europe.

Background
The Water Framework Directive (WFD) was established to protect inland surface waters, coastal waters and groundwaters. The WFD requires achieving a good chemical status for surface water and groundwater. A good chemical status is achieved for a surface water body when all environmental quality standards for the priority substances and other pollutants listed in Directive 2013/39/EU, the so-called ‘Daughter’ Directive of the WFD, are complied with. It defines a European priority list of substances posing a threat to or via the aquatic environment with respective environmental quality standards (EQS). EQS in the WFD define the concentration of a substance in water, sediment or biota, which is regarded as safe for the environment and human health and which must, therefore, not be exceeded. Currently, in 2021, Directive 2013/39/EU lists 45 substances or substance groups to WFD Annex X (Annex of EU priority substances).

The European Commission reviews the list of priority substances every 6 years, according to Art. 1 2013/39/EU. In practice, the list has only been reviewed twice: in 2008 (2008/105/EC) and in 2013 (Directive 2013/39/EU) since the setting of the priority substance list for first time in 2001. Art. 16 of WFD introduces a scientifically based methodology for selecting priority substances based on their significant risk to or via the aquatic environment.

The Fitness Check published in December 2019 concluded that WFD is broadly fit for purpose, but a problem related to a slow process of the revision of the list of WFD priority substances is evident and must be solved.

Pharmaceuticals – status in the WFD prioritization process
The working group dealing with priority substances under the WFD Common Implementation Strategy (CIS) is the Working Group Chemicals (WGCHEM). The substances have been shortlisted mainly by JRC and then selected by the WGCHEM based on monitoring-supported exceeding of the PNEC value and modelled data. There is evidence that these substances may pose a significant risk to the aquatic environment or human health. The selection of the substances is being and has been followed by a publicly open and transparent discussion with interested parties.

The revision of the list of WFD priority substances started in 2015, being interrupted during 2018-19 due to the WFD Fitness Check, but continued in 2020. The revision work includes not only the listing of new priority substances, but also considers the revision of EQS values and de-listing of current priority substances (de-listing not previously done).

So far (November 2021) the EQS values are being drafted for most shortlisted substances (substance specific EQS dossiers) which include several pharmaceuticals. Substance specific working groups containing JRC, Member State experts, industry and other interested stakeholders draft the EQS dossiers. The pharmaceuticals are well represented among candidate substances. It may indicate that pharmaceuticals will be included in the WFD priority substance list for the first time.

The short-listed pharmaceuticals are three macrolide antibiotics (erythromycin, clarithromycin & azithromycin), carbamazepine, diclofenac, three hormones (estradiol, ethinylestradiol and estrone) and ibuprofen. At the moment, for almost all the candidate pharmaceuticals, the EQS draft dossiers have been prepared and sent to the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) in order to get its scientific opinion on dossiers. Nevertheless, for some substances such as ibuprofen the preparation of EQS dossiers has just started. Thus, EQS dossiers are at a very different preparation stage.

European Union Strategic Approach to Pharmaceuticals in the Environment published in March 2019 by the Commission gives support for listing some pharmaceuticals in the WFD priority substance list.

Watch list mechanism
This WFD priority substance revision is the first time when the results of the surface water Watch List mechanism will be utilized. To support the monitoring-based process for the review of the list of priority substances, a watch list has been drawn up which is published every two years and contains around 10 substances suspected of exceeding EQS across Europe. The substances on the watch list are measured by all Member States and, if the proposed EQS is actually exceeded, may become candidates for the priority substances list (Art 8b WFD “daughter directive” 2013/39/EC). The main goal of the Watch List mechanism is to obtain high quality and comparable environmental monitoring data from all Member States. The Watch List only concerns authorities. Thus, regarding substances listed on the watch list, there is no direct obligation to undertake specific water management measures. The first Watch List was established in 2015 (2015/495/EU) and updated in 2018 (2018/840/EU) and 2020 (2020/1161/EU). A relatively high number of pharmaceuticals have been listed in all three surface water Watch Lists. The preparation of the fourth surface water Watch List is to be started in 2022.

The first groundwater Watch List, based on Groundwater Directive (2006/118/EC), is currently being prepared, but it will be voluntary for Member States and the substances have not yet been defined. The new Drinking Water Directive (2020/2184/EU) includes, for the first time, the Watch List substances for water intended for human consumption. The Watch List includes two substances, one of them being estradiol.

EU wide water related Watch Lists are big steps forward in the risk assessment of contaminants in Europe. Nevertheless, some harmonization is needed regarding the type of sampling points; i.e. if they are heavily or semi-polluted, or like background areas.

Schedule for further work
SCHEER has already given feedback for some candidate substances and is still preparing its scientific opinion on some draft EQS dossiers. This may take place at the beginning of 2022. The substance specific working groups will then further refine the EQS dossiers based on SCHEER feedback. The Impact Assessment of the Follow-Up to the WFD Fitness Check with a connection to a revision of the list of WFD priority substances has been scheduled to be finalized by June 2022. The European Commission may submit, perhaps at around the end of 2022, a proposal on the list of WFD priority substances with respective EQS values. After negotiations with Member States, industry and other stakeholders, the adoption of the list of WFD priority substances may take place at the end of 2023. The final decision to amend the list is to be taken with the approval of a so-called daughter directive based on the common legislative procedures. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the Directive amended WFD priority substance list within around two years after adoption (around 2025/ 2026).

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The updated Baltic Sea Action Plan – towards a Baltic Sea unaffected by hazardous substances

Authors:
Susanna Kaasinen, HELCOM Secretariat, susanna.kaasinen(at)helcom.fi
Owen Rowe, HELCOM Secretariat, owen.rowe(at)helcom.fi

The HELCOM Ministerial Meeting held on 20 October 2021 adopted the updated HELCOM Baltic Sea Action Plan (BSAP) containing almost 200 actions to improve the status of the sea. The updated plan has a segment dedicated to hazardous substances and litter with the goal “Baltic Sea unaffected by hazardous substances and litter”.

The Baltic Sea Action Plan (BSAP) is HELCOM’s strategic programme of measures and actions for achieving good environmental status of the sea, ultimately aiming for a Baltic Sea in a healthy state. Initially adopted by the HELCOM Contracting Parties – the nine Baltic Sea countries plus the European Union – in 2007, the original BSAP had set 2021 as the target year for achieving good ecological status of the sea. However, the results of the State of the Baltic Sea report, covering the years from 2011 to 2016, already indicated in 2018 that this target would not be met.

The updated BSAP is based on the original BSAP and maintains the same level of ambition. It also retains all actions previously agreed on that are still to be implemented, while it additionally includes new actions to strengthen the existing efforts and tackle emerging concerns.

Guided by the HELCOM vision of “a healthy Baltic Sea environment with diverse biological components functioning in balance, resulting in a good ecological status and supporting a wide range of sustainable economic and social activities”, the updated BSAP is divided into four segments with specific goals:

• Biodiversity, with its goal of a “Baltic Sea ecosystem is healthy and resilient”,
• Eutrophication, with its goal of a “Baltic Sea unaffected by eutrophication”,
• Hazardous substances and litter, with its goal of a “Baltic Sea unaffected by hazardous substances and litter”, and
• Sea-based activities, with its goal of “Environmentally sustainable sea-based activities”

Hazardous substances in the updated BSAP 
The majority of the actions related to hazardous substances are included in the hazardous substances and litter segment of the BSAP. The ecological objectives regarding hazardous substances are:

• Marine life is healthy;
• Concentrations of hazardous substances are close to natural levels;
• All sea food is safe to eat;
• Minimal risk to humans and the environment from radioactivity.

And the management objective is:

• Minimize input and impact of hazardous substances from human activities.

The segment includes 30 actions on hazardous substances with the aim of addressing the wide array of hazardous substances and human activities involved in their release to the environment. One of the key actions is to develop a regional strategic approach and, on the basis of that approach, an action plan for HELCOM work on hazardous substances by 2024 (action HL1). This holistic approach is needed to address not only the legacy pollutants such as heavy metals, dioxins or organotins, but also contaminants of emerging concern such as per- and polyfluoroalkyl substances (PFAS) and pharmaceuticals.

Furthermore, specific actions require improved awareness related to the appropriate disposal and handling of hazardous substances (e.g. actions HL7 and HL25), or improved consumer knowledge of the impact of pharmaceuticals in the environment (action HL27). Moreover, several of the actions are also directly targeting contaminants of emerging concern, for example, by taking concrete measures, such as strengthening the collection of unused pharmaceuticals from the public (action HL26), by filling knowledge gaps, such as to improve the knowledge related to the occurrence of pharmaceutical substances in the environment, their persistence and harmful effects (action HL22), or by evaluating priority pharmaceutical substances and developing guidance for monitoring, analysis and potential indicator development (actions HL23 and HL24).

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SUDDEN – tackling the environmental impacts of medicines across their life cycle

Authors: 
Jari Yli-Kauhaluoma, Tiina Sikanen & Sanja Karlsson, University of Helsinki
Kari Jalonen, Demos Helsinki

Correspondence to: Project coordinator, sanja.karlsson(at)helsinki.fi

SUDDEN is a multidisciplinary research program that aims to reduce environmental impacts of medicines across their life cycle from development until use, in close cooperation with experts in the pharmaceutical industry, healthcare, and policymaking.

Background
Medicines are vital for human wellbeing and public health, but their increased consumption - resulting from population growth and ageing - inevitably increases the pharmaceutical residues in the environment, as well as the medicine waste across the drugs’ life cycles. SUDDEN project, short for Sustainable Drug Discovery and Development with End-of-life Yield, seeks for new solutions to the management of environmental hazards of medicines at the molecular and product levels, and to environmentally sound policies that could support the rational use of medicines and sustainability of the ancillary healthcare systems. The SUDDEN research program (2018-2023) receives funding from the Strategic Research Council (SRC) established within the Academy of Finland and is part of SRC’s Keys to Sustainable Growth programme.

The SUDDEN consortium
The SUDDEN consortium is coordinated by the University of Helsinki and involves five other Finland-based research organizations, uniting experts in drug discovery and pharmacoeconomics, international environmental law and risk assessment, water purification technology, metal and plastic recycling, and transformation research: University of Helsinki, Aalto University, LUT University, Finnish Environment Institute SYKE, University of Eastern Finland and the Demos Helsinki.

Elimination of pharmaceutical residues in wastewaters and sewage sludge
The majority of pharmaceutical residues pass the municipal wastewater treatment processes unchanged, distributing to the receiving water bodies and/or the sewage sludge. For one part, the focus on ongoing SUDDEN research is to evaluate and improve the purification efficiencies of different tertiary technologies, such as adsorption to activated carbon, oxidation via pulsed corona discharge and membrane filtration, in the removal of pharmaceutical residues from wastewaters (LUT University). For the other part, the ongoing research focuses on safe recycling of sewage sludge by building a better understanding of the fate of pharmaceutical residues in the different sludge treatment processes, such as digestion and composting, pyrolysis, and incineration, as well as in sludge-fertilized soil (Finnish Environment Institute SYKE).

Safe and efficient recycling of pharmaceutical packaging waste
Packaging of pharmaceutical products aims at ensuring the high quality and safety of medicines to the user, including protection against falsified medicines. In some cases, however, this necessitates the use of environmentally damaging materials (e.g., PVC) or rare metals (especially aluminum), but there are also regional preferences that augment the use of certain problematic packaging types, such as the favoring of PVC-aluminum blisters as primary packages in the EU. To manage this regionally relevant waste segment more effectively, SUDDEN research focuses on the development of metallurgy methods for the processing of blister waste (Aalto University) in a way that could facilitate sustainable aluminum recycling, instead of its incineration (current norm). Adhering to the EU’s plastics strategy, SUDDEN also evaluates safe recycling practices for plastics used in pharmaceutical primary packages (Finnish Environment Institute SYKE).

Research highlights: 

• Electrohydraulic Fragmentation of Aluminum and Polymer Fractions from Waste Pharmaceutical Blisters (ACS Sust. Chem. Eng. 2020). (acs.org)

New strategies for pharmaceuticals environmental risk assessment
Given the fact that the current pharmaceutical legislation, or the regulatory framework governing environmental risk assessment (ERA), are forceless in limiting the environmental exposure resulting from the human use of medicines, it is utmost critical to understand the validity of regulatory ERA data in predicting the true environmental hazards. In this respect, SUDDEN research focuses on exploring the prevailing methodological limitations and identifying the knowledge gaps in the regulatory ERA (Finnish Environment Institute SYKE and University of Helsinki). This is further supported by regulatory analysis of the feasibility of the “(benign) by design” approach to support progressive risk governance of innovative technological developments and to enhance the interdisciplinarity in risk regulation (University of Eastern Finland, Law School). SUDDEN also aims to introduce and validate a range of in vitro effects models for fish – the species most sensitive to nontarget effects of environmental drug residues - that could foster the use of nonanimal assays for ERA purposes (University of Helsinki). These activities address the prevailing ethical gap in regulatory ERA, and also interlink SUDDEN with the ongoing PREMIER project (2020-2026), funded under the Innovative Medicines Initiative, by the EU and the European Federation for Pharmaceutical Industries and Associations.

Research highlights:

• “By Design” and Risk Regulation: Insights from Nanotechnologies (Eur. J. Risk Regulation 2020). (cambridge.org)
• Cytochrome P450 Inhibition by Antimicrobials and Their Mixtures in Rainbow Trout Liver Microsomes In Vitro (Environ. Toxicol. Chem. 2021). (cambridge.org)

Environmental and financial sustainability of the healthcare systems and pharmaceutical industry
Besides regulatory requirements, environmentally sound decision-making needs to extend from individuals to societal systems, and, eventually, to the development of pharmaceuticals intrinsically less harmful for the environment. To account for the impact of cultural variation, a focus point of SUDDEN research is to understand the consumers’ attitudes toward and willingness to pay for environmentally sound medicines (University of Eastern Finland, School of Pharmacy). Together with the Swedish Knowledge Center, SUDDEN has also explored national approaches to promote the adaptation of environmental criteria in the public procurement of medicines, supported by evaluation of national and international regulation applied to drug production and distribution chains (University of Eastern Finland, Law School). Furthermore, SUDDEN aims to support the development of greener drug manufacturing schemes and to incorporate the environmental fate (predictions) as part of the computational drug discovery and chemoinformatics workflows (University of Helsinki), in a way that does not create significant cost barriers to the overall (industrial) drug development process. Altogether, these activities focus on the identification of tangible incentives for pharmaceutical industry and policymaking, with the overall aim of reducing the environmental impact of medicines across their life cycle.

Research highlights: 

• Attitudes and Considerations towards Pharmaceuticals-Related Environmental Issues among Finnish Population (Sustainability 2021). (mdpi.com)

Moving forward
To accelerate the translation of research results to product and service innovations, SUDDEN is about to kick-off an Innovation Brokerage Program in 2022, which seeks to connect the project researchers with practitioners in chosen sectors in the effort of facilitating further development and implementation of research-based innovations as part of environmentally sound decision-making on all levels. More information on the SUDDEN research findings, as well as of past and upcoming stakeholder activities, is communicated via the project website.

What´s new in Baltic Sea Pharma Platform?

Authors: Lauri Äystö and Noora Perkola, Finnish Environment Institute, BalticPharma(at)syke.fi

During spring 2021, the Baltic Sea Pharma Platform lead was transferred from the Swedish Environment Protection Agency to the Finnish Environment Institute (SYKE). As the new lead, SYKE aims to reactivate the platform and keep it active throughout the year. This newsletter is the first step in this process.

BSR Pharma
The Baltic Sea Pharma Platform (BSR Pharma) aims to promote knowledge transfer and the implementation of measures to limit the emissions of pharmaceutical residues into the environment. BSR Pharma also offers a platform for project development.

BSR Pharma was launched in 2017. At roughly the same time, UNESCO and HELCOM published a status report: Pharmaceuticals in the aquatic environment of the Baltic Sea region. The report highlighted the widespread occurrence of pharmaceuticals in the BSR environment, such as the high detection frequencies of carbamazepine in Baltic Sea water samples, and gave a number of recommendations on future research projects and how emissions into the BSR environment could be mitigated. The compilation of analytical data and recommendations laid ground for future projects in the field.

Activities within the BSR Pharma rely on the activity of its participants and projects in the field. Projects MORPHEUS, CWPharma, MicroWasteBaltic and GrePPP, and, undoubtedly, many others, played an important role in the BSR Pharma during 2017–2020.

New leaders
From its launch in 2017 until 2020, the platform was led by the Swedish Environment Protection Agency (SEPA). At the beginning of 2021, the lead responsibility was transferred to the Finnish Environment Institute (SYKE). The new platform leaders (Lauri Äystö & Noora Perkola) have both worked in the field of pharmaceuticals in the environment (PiE) for several years. Noora was the CWPharma project leader, while Lauri took part in the project as an activity leader. Both have participated in several Finnish projects in the field.

The transfer of the lead responsibility coincided with the finalization of the last platform project (CWPharma). Thus, one of the short-term goals of the new platform leaders is to identify the most relevant ongoing projects and potential project consortia in the region. To help identify relevant projects, and to let platform participants have a say on how the platform is developed, a questionnaire was launched in June 2021.

Responses to the questionnaire
The questionnaire received altogether 18 replies. While the quantity of respondents was not beyond comprehension, their quality was. Several new and ongoing projects were highlighted for SYKE, accompanied by ongoing processes, such as awareness raising, UWWTD revision, and stakeholder dialogues. This newsletter was compiled in cooperation with some of these new and ongoing projects.

Moreover, every respondent wanted to keep receiving information about the BSR Pharma. The aspects given highest priority within the PiE field were API occurrence and risks, environmental legislation, and emission reduction measures. Over 50% of the respondents also showed an interest towards antimicrobial resistance. Over 80% of the respondents wished to receive a platform newsletter. Electronic meetings were given a slight preference over physical ones. To accommodate this, we aim to organize a webinar / project development workshop at the end of the year.

Your input is needed
To help us as the new leaders of the BSR Pharma, we invite you to bring any ongoing or upcoming projects and projects still in their development phase to our attention! As SEPA did before us, we will rely strongly on participation from projects and individuals working in the field.

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Call for interested stakeholders – be part of the future REPHIRA consortium

Authors: Alena Kaiser, Rostock University, alena.kaiser(at)uni-rostock.de, 
Jens Tränckner, Rostock University, jens.traenckner(at)uni-rostock.de

The Baltic Sea constantly receives pharmaceutical loads emitted not only in the urban coastal areas, but also upstream. REPHIRA aims to focus on these typically rural areas to support the European Zero Pollution Goal and is searching for future project partners! 

Background – Where is the problem?
For reducing the emission loads of human pharmaceuticals and other emerging contaminants, most Baltic Sea Region (BSR) countries realised that an upgrade of the largest coastal Waste Water Treatment Plants (WWTPs) is inevitable in the future. The first concepts for the implementation of advanced treatment techniques have been initiated by various projects within the BSR. However, in the typically rural hinterland, emissions from small WWTPs and not yet clearly identified point sources must be regarded, too. These upstream sources have a significant impact especially on the small rivers and streams and their accumulated impact on large water bodies, including the Baltic Sea itself, should also be taken into consideration. However, the implementation of advanced treatment in those plants is challenging for economical, technical and operational reasons. So, a well-reasoned prioritisation of feasible end-of-pipe measures must be accompanied by other mitigation measures, including source control. Besides, regional stakeholders responsible for future prioritisation and decision-making have expressed a need for harmonized approaches in monitoring concepts, and the data handling and assessment of emerging contaminants both at WWTPs and in the environment.

Aim of REPHIRA – What is the project for?
The partners of the currently running Seed Money project REPHIRA – financed by Interred Baltic Sea Region -   focus on rural areas in the BSR and are developing a concept for the future main project. To achieve a sustainable and comprehensive progress in reducing pharmaceutical emissions in rural areas (= REPHIRA), the different needs expressed by interviewed stakeholders and requirements will be translated into tasks relevant for our regarded target groups. Generally, we can differentiate between three levels of action: International, regional and local. At the international level, the Baltic Sea Region is defined by the catchment area and all countries are involved in environmental developments via the HELCOM and EU-wide directives. Even though common frameworks exist, their handling and implementation is diverse, especially relating to emerging contaminants. Therefore, we intend to stimulate new and support already existing dialogues by introducing recommendations and good practices to improve existing approaches. At the regional level, the actual river system analysis to understand deficits, drivers and impacts, as well as a consistent prioritisation of implementation measures, is the main challenge. Here, we intend to develop helpful and widely applicable decision support tools. Within each region, we intend to identify suitable case study areas, where the local actors should be brought into an early dialogue process, which also includes the adequate commitment of the main polluters. In rural areas, potentially relevant emitters are large health care facilities, tourism and pharmaceutical related industry. In some cases, source control measures at hot spots may be constructive, while, in other cases, an economic support to central treatment measures may be more suitable. In selected case studies, actual treatment technologies will be planned and tested. All over the different levels of action, the dialogues and inter- + intra-disciplinary collaboration are the core of the future project, to design practicable tools and methods for the whole BSR.

The consortium – Who would participate?
In the seed money project, strong partners from previous and ongoing successful Interreg projects are working together, namely SYKE, Kristianstad University, Gdansk Technical University and Rostock University supported by the Danish and German EPAs. For the forthcoming main project, the consortium will be extended. We seek partners who are responsible for decision-making in the field of regulation, monitoring concepts and data evaluation, environmental risk assessment regarding emerging contaminants or AMR at the local or regional level.

In that way, we intend to adapt future project activities to the actual needs and design useful tools for practice. Exemplary activities could include conducting workshops and trainings, as well as coordinate dialogues in professional round tables, where e.g. experts in data evaluation, monitoring concepts or environmental risk assessment/ecotoxicology will work together. For local case studies, WWTP operators are welcome, too.

At the same time, we would appreciate gaining interested partners from Estonia, Lithuania and Latvia to have a more complete picture of environmental heterogeneity within the Baltic Sea Region. Namely, national and regional EPAs are encouraged to bring in their experience, needs and willingness to actively join the team.

If you believe that you are the partner we are referring to, you are welcome to contact us for more information about the contents as well as an initial talk to get to know each other and to exchange ideas and expertise for a fruitful cooperation!

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Presence of pharmaceuticals in wastewater studied within a large-scale project in the Baltic states - Latvia and Lithuania

Author: Maruta Vehi, Latvian Environment Geology and Meteorology Centre, maruta.vehi(at)lvgmc.lv

To study the pollution of pharmaceutical active compounds in wastewater and water bodies in Latvia and Lithuania, scientists, researchers and experts from both countries have been working together under a joint project for almost two years from now. The project “Pharmaceuticals in wastewaters–levels, impacts and reduction” (MEDWwater) is financed by the EU, and the search for a solution to reduce the pollution caused by pharmaceutical products is among the project’s key goals.

The project aims to increase the efficiency of pharmaceutical substances pollution management and to increase cooperation between governmental institutions and wastewater treatment plant operators.

In Latvia and Lithuania, information and the monitoring of pharmaceuticals in the environment are very limited. Most data on environmental levels in both countries are collected in different projects, therefore, project MEDWwater will help to fill knowledge gaps. There is a need to collect the information to understand and evaluate certain pharmaceuticals regarding their environmental concentrations in various sizes of WWTP and the resulting levels of risk.

Previously, Latvia and Lithuania participated in two international projects under which research about the pollution of pharmaceutical active compounds were implemented (CWPharma and Morpheus). The MEDWwater project is a continuation and the first big-scale research carried out in Latvia and Lithuania at the same time. Within this project, the concentration of substances will be established in water both before and after wastewater treatment plants, the environmental impact will be determined, and solutions will be searched for in order to improve the situation.

The project manager researcher Ieva Putna-Nīmane from Daugavpils University Agency “Latvian Institute of Aquatic Ecology” points out that this kind of pollution is a topical issue. “Although there are some clues and data from the previous projects suggest that there is pollution with pharmaceutical active compounds in the territory of Latvia and Lithuania, as we use medications, we cannot make any conclusions about its scale yet. Therefore, we are glad that the project MEDWwater was supported and has been launched.” She informed that, within the project, 25 pharmaceutical active compounds will be identified, the establishment of concentration of which in wastewater is recommended by the EU, together with substances used by the inhabitants of Latvia and Lithuania in comparatively large amounts. At the end of the project after studying the data obtained, the scientists will draw conclusions about the harm that the presence of pharmaceutical active compounds may cause to the environment.

Since February 2021, MEDWwater project partners, in close cooperation with environmental authorities, were working on the selection of relevant municipal wastewater treatment plants (WWTPs) and water bodies (wastewater recipients) in Lithuania and Latvia for further investigations of actual pharmaceuticals loads. Based on the agreed upon selection criteria, experts from Klaipėda university (LT) and Latvian Environment, Geology and Meteorology Centre (LV) have identified urban wastewater agglomerations of more than 2 000 population equivalent located in both countries. When selecting WWTPs, the priority was given to the ones located in Lithuania-Latvia shared River Basin Districts of Venta and Lielupe rivers and coastal areas. Additionally, in-depth analysis of existing strategic environmental documents and available monitoring data was completed in order to identify WWTPs, characterized by less effective treatment technologies and needed to be upgraded in the nearest future. The quality of the treated wastewater and presence of hazardous substances in waste waters during 2017–2019 monitoring period were also considered. In total, 16 WWTPs (8 from LT and 8 from LV) were selected for further characterization and deeper research during the next MEDWwater implementation stages.

The first samples have been collected in July 2021, but the second sampling campaign will take place in December 2021. The chemical analysis of the collected samples will be performed by using state-of-the-art equipment of the Coastal Environment and Biogeochemistry Laboratory at the Marine Research Institute, Klaipėda University.

In cooperation with experienced foreign experts, recommendations and technical solutions for a better removal of pharmaceutical active compounds will be provided to two operators of wastewater treatment plants. Having summarised the project results, experts will prepare recommendations for wastewater monitoring. One of the project activities, the strategic document “Recommendations for wastewater treatment plants”, will allow a better management of nature resources not only within the Programme’s territory but also on a national scale in Latvia and Lithuania.

Along with the scientific research part, the project also includes an information, education and communication campaign about the adverse effect of pharmaceuticals on the environment and how to dispose of drugs after their expiration date or when they are not used.

The project gathers scientists, environmental experts and other specialists from Daugavpils University Agency “Latvian Institute of Aquatic Ecology”, the Latvian Environment, Geology and Meteorology Centre, Kurzeme Planning Region, State Agency of Medicines, State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, and Klaipėda University.

Project in a nutshell
Project duration:
February 1, 2021 – December 31, 2022.

Project budget:
Total projects size is 673 772.88 EUR.
Out of them co-funding of European Regional Development Fund is 572 706.92 EUR.

Project Partners:
Lead Partner – Latvian Institute of Aquatic Ecology Agency of Daugavpils University, www.lhei.lv, in cooperation with 5 partners from Latvia and Lithuania:

• Kurzeme Planning Region, (kurzmesregions.lv)
• Latvian Environment, Geology and Meteorology Centre, www.videscentrs.lvgmc.lv
  University of Klaipeda, (ku.lt)
• State Agency of Medicines of Latvia, (gov.lv)
• State Medicines Control Agency under the Ministry of Health of Republic of Lithuania, (vvkt.lt)
   

Project partner coordinator for MEDWwater project:

• Maruta Vehi, Latvian Environment Geology and Meteorology Centre, maruta.vehi(at)lvgmc.lv
   

More information on the Programme website. (latlit.eu) 

This publication has been produced with the financial assistance of the European Union. The contents of this publication are the sole responsibility of Latvian Environment Geology and Meteorology Center and can under no circumstances be regarded as reflecting the position of the European Union.

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CWPharma 2 is getting pharmaceuticals removal in wastewater into reality

Authors: 
Kai Bester, Aarhus University, kb(at)envs.au.dk 
Michael Stapf and Ulf Miehe, Berlin Centre of Competence for Water

CWPharma 2 is the expansion project of CWPharma and focuses on the removal of pharmaceuticals from wastewater, based on the guidelines of CWPharma. The special needs of wastewater treatment plants in the Baltic Sea region for operating ozonation, granular activated carbon treatment and biofilms are in focus.

Emissions of active pharmaceutical ingredients (pharmaceuticals) into the aquatic environment are a topic of growing interest throughout the whole Baltic Sea region, as their presence can have a negative impact on the aquatic environment, as well as on groundwater and drinking water sources. To get a better understanding of the various pathways of pharmaceuticals into the Baltic Sea, the CWPharma project (Clear Waters From Pharmaceuticals) conducted an extensive screening campaign and used the data to set up the Baltic Pharma Load-model (BPL). CWPharma also investigated how these pharmaceutical emissions can be reduced through technical and non-technical measures. The findings were condensed into several guidelines with actionable recommendations for authorities, wastewater treatment plant operators and political decision makers, and are available on the project homepage.

The follow-up project CWPharma 2, which is also funded by the EU’s Interreg Baltic Sea Region Programme, focuses on the practical implementation of the CWPharma “Guideline for advanced pharmaceutical removal”  to support WWTP operators in bringing full-scale pharmaceutical removal to life. CWPharma 2 is working on the following four main tasks:

• Fitness check for pharmaceutical removal technology
• Applying recommendations for planning pharmaceutical removal and plant optimization
• Detailed planning and implementation of pharmaceutical removal at WWTP Hillerød
• Filling public awareness gaps identified in the initial CWPharma project
   

Fitness check for pharmaceutical removal technology
Based on the guideline’s recommendations, a fitness check of WWTPs in the Baltic Sea region will be conducted as a first step towards the implementation of a pharmaceutical removal technology. Technologies such as ozonation or adsorption onto activated carbon are able to remove pharmaceuticals in full-scale. However, each WWTP is unique and can have local boundary conditions that favor or inhibit certain technologies. Additionally, data gaps may present problems, and being aware of them is useful for conducting specific measurement campaigns at an early stage. Examples of potential barriers could be: high fractions of industrial wastewater (an unexpected formation of potentially toxic compounds), sludge disposal routes (sludge containing PAC must be incinerated), or elevated bromide concentrations (formation of carcinogenic bromate during ozonation). High bromide levels can be found in particular at WWTPs in coastal areas, e.g., due to sea water intrusion into the sewers or due to high bromide levels already in the drinking water. However, as bromide is not a commonly monitored parameter, hardly any WWTP operators are aware of this potential obstacle.

To date, CWPharma 2 has conducted a fitness check for around 80 WWTPs within the Baltic Sea region via the distribution of a questionnaire and the analysis of a water sample from the interested WWTPs.

Applying recommendations for planning pharmaceuticals removal and plant optimization
CWPharma’s guideline for advanced pharmaceuticals removal processes provides a condensed overview of relevant and critical aspects when planning or operating a WWTP with a pharmaceutical elimination treatment stage. However, when implemented in practice, further questions may arise (e.g., how exactly to interpret data from monitoring or pre-trial experiments) which affect the planning process or optimal operation of the existing tertiary treatment stage.

Therefore, selected WWTP operators (HSY, HFORS and Kohlia WWTP operator via EVEL) are being supported by implementing the recommended steps of the guideline (Guideline module 2) and conducting a feasibility study on pharmaceutical removal technology. During this process, the guideline will undergo a field-test and feedback from the involved parties (e.g. WWTP operators, water authorities or engineering companies) will be used to update it accordingly. The selected study sites (Helsinki WWTP, FI; Hillerød WWTP, DK; Kohila WWTP, EE) include a broad range of boundary conditions (e.g., WWTP size, combination of pharmaceutical and phosphorous reduction) and, therefore, cover multiple aspects of the guideline.

Additionally, strategies for bromate minimization will be tested at the full-scale ozonation plant coupled with MBBR post-treatment of Kalundborg WWTP. The practical application of the bromate minimization strategy (e.g. catchment assessment for bromide sources, bromate reduction by MBBR post-treatment) will serve as an example for other Baltic Sea WWTPs which also detect high bromide levels in their wastewater.

Detailed planning and implementation of pharmaceuticals removal at WWTP Hillerød
CWPharma 2 is using the pharmaceuticals removal guideline developed in the CWPharma project to support the planning of a full-scale pharmaceuticals removal stage at WWTP Hillerød (DK). Pharmaceutical removal is planned to be operational in 2024, by which time a large hospital for the Copenhagen metropolitan area will be built in Hillerød. The environmental authorities have specified the performance necessary for the WWTP, and the operator HFORS has agreed to tackle the additional hospital pharmaceuticals emissions. HFORS is implementing and conducting the recommended short-term piloting phase (ozonation and treatment with granulated activated carbon) to determine the required design parameters for ozonation, as well as post-treatment for the pharmaceutical removal stage at WWTP Hillerød. The evaluation will be based on relevant water quality parameters, including pharmaceuticals and transformation products analysed by Aarhus University (AU) as well as bioassays recommended in CWPharma’s guideline performed by the German EPA (UBA) and IOS in Poland. The results will be directly fed into the planning process of the full-scale treatment stage and the project will adhere to the various design parameters required by the utility (e.g. ozone dosage, ozone production capacity, oxygen demand, size of reaction tanks, design of post-treatment and cost of operation).

Currently, HFORS has completed extensive testing of ozonation and GAC filtration. Due to the Danish regulations, the measurement program (AU) was expanded from 35 to 55 pharmaceuticals and 20 metabolites.

Filling public awareness gaps identified in the initial CWPharma project
Within the initial CWPharma project, awareness of pharmaceuticals in the environment and the proper disposal of unused pharmaceuticals was found to be quite variable within the Baltic Sea countries. In certain countries (DE, SE, FI), the occurrence and effects of pharmaceuticals are already discussed in mass media (e.g., press, television, print), and communicated through governmental information campaigns. In contrast, much less information on pharmaceuticals in the water cycle is available in countries such as the Baltic States and Poland. This poses a serious obstacle in reducing the overall pharmaceutical load into the Baltic Sea, since, for example, Poland is a major contributor of pharmaceutical loading and public awareness is key for the acceptance of reduction measures (e.g. correct disposal of unused pharmaceuticals, cost of advanced treatment stages on WWTPs).

Thus, within CWPharma 2 it is planned to produce a video about APIs in the environment and the correct disposal of unused pharmaceuticals with a focus on Poland and the Baltic States.

The CWPharma 2 project consortium consists of nine partners from six Baltic Sea countries: Aarhus University (AU), Berlin Centre of Competence for Water (KWB), German EPA (UBA), Kalundborg Utility (Kalfor), the Latvian Institute of Aquatic Ecology (LIAE), Estonian waterworks association (EVEL), the Polish Institute of Environmental Protection – National Research Institute (IOS), Hillerød Utility (HFORS), and the Helsinki Region Environmental Services Authority (HSY). The project is coordinated by Aarhus University. Coordinator is Kai Bester.

More information on projects website. (au.dk)