Five EU-funded H2020 and FP7 research projects i.e. EDC-MixRisk, EuroMix, EU-ToxRisk, HBM4EU and SOLUTIONS, are working together to address different aspects of the impacts of chemical mixtures and combined exposure. The projects have engaged into an exchange between the consortia, European Commission Services and relevant EU Agencies in order to identify remaining gaps in mixture research and policy. As a result of this effort, a joint workshop entitled “Advancing the Assessment of Chemical Mixtures and their Risks for Human Health and the Environment” was organised at Joint Research Centre, Ispra, 29-30 May 2018. The workshop brought together around 60 experts working in the field of chemical mixtures.

The workshop provided a great forum to discuss the latest advancements in science as well as research and policy needs in order to make progress in mixture risk assessment and management. The topics of the workshop included hazard and exposure assessment, data and tools, and risk analysis and governance. The international horizons and developments outside the EU were covered by keynote speakers from USA, Japan and OECD.

Although much progress has been achieved over the recent years, the participants stated that it is evident that more needs to be done to better address the combined exposure of multiple chemicals, both in terms of intentional (e.g. pesticides and cosmetic products) and unintentional mixtures (e.g. contaminants via air). One of the major gaps continues to be the lack and availability of data. The Information Platform for Chemical Monitoring, IPCHEM is addressing the gap for chemical monitoring data. However, another big challenge remains in the accessibility and quality of data on (eco)toxicological properties and on the types of use of chemicals.

In the group and plenary discussions, ideas were brought up on improving governance aspects to better protect public health and environment from hazardous chemical mixtures. The proposals from many project participants included e.g. encouraging policymakers to look into the opportunities of establishing clear legal mandates for mixture risk assessment within EU chemicals and environmental legislation and across the regulatory silos. It was also suggested that “protection goals” should be established for human health, applying the idea and concept from the Water Framework Directive which requires good chemical and ecological status for European water bodies. For humans, similar type of “protection goals” could be set for good chemical and health status. Furthermore, it was raised that there is a need for developing uniform principles and harmonised approaches for performing human and environmental mixture risk assessments. In practice, also procedures should be piloted and put in place to enable more holistic and systematic mixture risk assessments, across regulatory bodies and sectors. It was concluded that interdisciplinary and international collaboration as well as dialogue between scientists, regulators and policy-makers are essential to make progress in the mixture efforts.

The workshop outcome and future research needs will be published later in 2018.

JRC has published recently a news item on chemical mixtures and safety of combined exposures here.

JRC has also published a related Policy Brief: “Something from nothing? Ensuring the safety of chemical mixtures”.

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The first European Exposure Science Strategy Workshop, will be held 19-20 June 2018 in Dortmund, Germany. This workshop is organised by ISES-Europe and will provide an unique opportunity to shape the strategy for exposure science in Europe. For details about the program on advancing exposure science in Europe see here.

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To express concern and raise awareness on hazardous chemical mixtures and combined exposure, the Coordinators and representatives of several EC funded research projects, EDC-MixRisk, EuroMix, EU-ToxRisk, HBM4EU, SOLUTIONS, have sent a position paper (17 April 2018) to Director‐Generals of DG Environment, DG Research and Innovation and DG Health and Food Safety.

The position paper entitled “Preventing risks for people and environment from hazardous chemical mixtures” calls for action, taking benefit from the step-wise translation of the science i.e., employment of already existing as well as development of new approaches, methodologies and tools. It proposes 12 key actions and recommendations to help better address combined effects and overcome remaining gaps in chemical mixture research and policy making. It also provides some feedback and ideas from research projects’ perspective to the preparations of the next Framework Programme, Horizon Europe.

Link to the Position Paper.

Researchers and stakeholders agreeing with the key messages have the opportunity to support the initiative and co-sign the position paper (until 31 May 2018).

Link to the co-signing form.

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Five EC funded H2020 and FP7 research projects i.e. EDC-MixRisk, EuroMix, EU-ToxRisk, HBM4EU and SOLUTIONS, are working together to address different aspects of the impacts of mixtures on human health and the environment, including also research activities at the European Food Safety Authority (EFSA) and the Joint Research Centre (JRC). Through this collaboration, synergies, knowledge exchange and the ability to exchange and use methods and data will be promoted.

A joint workshop ‘Advancing the Assessment of Chemical Mixtures and their Risks for Human Health and the Environment’ will be held 29-30 May 2018 at the Joint Research Centre in Ispra, Italy. The aim is to discuss the current state of knowledge as well as further elaborate and prioritise areas for future policy and research needs. The active participation of experts from EFSA, JRC, the European Environment Agency and Directorate General Environment, as well as Directorate General for Research and Innovation will ensure policy relevance of the discussions.

The topics of the workshop include hazard and exposure assessment, data and tools, and risk analysis and governance. The meeting will focus on setting the scene in terms of governance and policy frameworks as well as on advancement in research, knowledge and identification of gaps. Further research and policy needs in the field will be discussed and elaborated together with the workshop participants. Also, there will be an opportunity to learn about the international approaches from U.S., Japan and OECD work. The intention is to publish the outcome of this workshop in a scientific journal. The ultimate aim of the collaboration is to maximise the impact of the work on mixtures and to enhance chemical safety.

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EuroMix is testing the effects of mixtures of chemicals in several different assays using cell lines, zebrafish and animal models. The results of the testing is analysed using the Benchmark dose method to calculate the relative potency and dose-additivity of the different chemicals.

On March 22, 2018 EuroMix participants were trained in using the PROAST web application for Benchmark dose analysis. The training was organized by Wout Slob, RIVM and Johanna Zilliacus, Karolinska Institutet.

EuroMix awarded with “Top ten mixtures abstracts” at SOT meeting

The human biomonitoring study in EuroMix was presented as an abstract and a poster at the 57^th annual meeting of Society of Toxicology (SOT) in San Antonio Texas last week. The abstract was awarded as “Top 10 mixtures abstract” in the Mixtures Speciality Section.

The preliminary results presented as a poster on SOT, illustrates that the reported 24h use of personal care products (PCPs) by 144 adult volunteers in Norway were correlated with urinary levels of several phenolic compounds in 24h urine samples. Pairwise correlations were found between the use of all PCPs, body lotion, anti-wrinkle cream and hand cream and urinary levels of oxybenzone (OXBE). Furthermore there was a pairwise correlation between the use of foundation and urinary levels of bisphenol F (BPF), the use of lip-gloss and urinary ethyl paraben (ETPA) and the use of hand cream and urinary propyl paraben (PRPA).

here is the poster.

Hubert Dirven and Trine Husøy attended the SOT conference and experienced a lot of interest in the EuroMix project. Monica Andreassen prepared the abstract and the poster.

Can Alternatives Inform the Risk Assessments of Mixtures in Food?

March 27, 2018
8:30 am-12:50 pm ET (GMT-4)
Wiley Auditorium, US FDA, College Park, Maryland

Chair: A. Wallace Hayes, University of South Florida College of Public Health, Tampa, FL, and Institute for Integrative Toxicology, Michigan State University, East Lansing, MI

Co-chair: Suzanne Compton Fitzpatrick, US FDA, College Park, MD

Registration for On-site Participation Deadline: March 19, 2018
Registration for Webcast
Colloquium website

SOT and the US FDA Center for Food Safety and Applied Nutrition (CFSAN) cordially invite you to join us for our March colloquium, “Can Alternatives Inform the Risk Assessments of Mixtures in Food?” Current risk assessments of chemicals in food do not generally consider exposure to multiple substances but rely instead on the assessment of individual substances in individual food commodities. Humans however are routinely exposed simultaneously to numerous chemicals in food.  These mixtures can be variable and constantly changing and defining them presents a challenge.  Models could be used independently and in an integrated manner to assess health impacts. This symposium will examine whether new testing approaches such as in vitro, in silico models, and non-mammalian in vivo models could be used to assess the potential health impacts of exposure to chemical mixtures in food.

Presentations include:

Successful workshop on developing the IPCHEM data platform to support the assessment of chemical mixtures

On 11 and 12 December 2017 a workshop was held at the EC Joint Research Centre (JRC) in Ispra, Italy, aiming to discuss the further development of the IPCHEM data platform (https://ipchem.jrc.ec.europa.eu) for supporting the assessment of chemical mixtures. A number of selected experts and the European Commission services (ECHA, EFSA, EEA, DG ENVI, DG RTD) as well as representatives form European research projects were invited and present at the meeting.

The European Commission is aiming to have one access point for all chemical occurrence data in Europe. The European authorities EFSA, EEA and ECHA are cooperating on this initiative by contributing relevant data. European projects as for example HBM4EU (https://www.hbm4eu.eu/) will organise their biomonitoring data in the IPCHEM platform.

Jacob van Klaveren from RIVM and Hilko van der Voet from Wageningen University & Research presented the EuroMix project and the EuroMix model platfom. It was seen as a complementary tool to the IPCHEM database. The EuroMix presentations were well received. JRC intends to implement web services to facilitate data access from the EuroMix toolbox, and to provide on their website a link to the EuroMix toolbox for performing mixture risk assessments.

With the IPCHEM platform we expect that data needed for mixture risk assessment will become available in a more coherent manner. It will include dietary and non-dietary chemical occurrence data as well as detailed properties of chemicals.

These developments will certainly boost the discussion on how to maintain the EuroMix tools after the project will end and how to continue to work on the EuroMix concept (risk assessment based on AOP data). It was also discussed how to link EuroMix better to HBM4EU data or how HBM4EU observation might prioritise our next case studies. We will start considering useful links and new case studies soon and plan to discuss these possibilities in the next EuroMix consortium meeting.

JRC will make an official communication of this workshop including the presentations given.

EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches (2017) is now available.

EuroMix was included in this Science for Policy report published by the Joint Research Centre (JRC), the European Commission’s science and knowledge service. It aims to provide evidence-based scientific support to the European policy-making process and presents an update on the development, validation and regulatory acceptance of alternative methods to animal testing.

EuroMix contributed to EPAA Partners Forum: Finding synergies for 3Rs Toxicokinetics and read‐across

On November 21^st 2017, partners in the European Partnership for Alternative Approaches to Animal Testing (EPPA) met in Brussels to build synergies on the development and acceptance of Toxicokinetics (TK) and read‐across. The EPAA Partners Forum brought together 33 expert participants from industry and European Commission (EC), along with selected representatives from regulatory agencies and invited researchers from two EU‐funded H2020 research projects (EuroMix and EUToxRisk). Dr. Vikas Kumar from University of Rovira I Virgili (Spain) represented the EuroMix project in this meeting.  Dr. Kumar presented “Toxicokinetics and read across in EuroMix” and discussed how research in EuroMix is helpful for the wider stakeholders and why collaboration is necessary for the society. This EPAA Partners Forum was part of EPAA activities to address one of 6 challenges as a priority i.e. to improve intra and inter sectorial collaboration and coordination. EPAA is a relevant platform to build synergies across sectors, given its multi‐sectoral structure encompassing different business sectors. Besides exchanging information between sectors about their respective research agendas and activities in the sectorial flagship initiatives, the event was meant as an opportunity for the partners to identify possibilities for synergies, receive feedback and present scientific input relevant for EPAA. Discussions revolved around four balanced sessions aiming at covering the whole spectrum of stakeholders working on Toxicokinetics (TK) and read‐across i.e. regulators, the regulated, method developers and downstream users.

At the end of the day, a scientific consensus was achieved on the following four items:

• TK data play an important role in risk assessment across all industry sectors and are subject to significant research effort by all relevant stakeholders
• TK data strengthen the read across weight of evidence; TK data should ideally be anchored towards human relevance, preferably generated using in silico and in vitro tools
• Identification and characterization of Metabolism is a key component of TK assessment in read-across
• The forum expressed confidence that significantly more progress in TK can be made if collaboration between sectors is enhanced and synergies are captured.

The participants’ discussion was captured by a scientific writer and a scientific publication is currently under preparation.