Report on characterisation of New Psychoactive Substances (NPS)

The emergence of designer drugs as abused substances has seen a dramatic increase over the past few years. About 70 new psychoactive substances were discovered in 2012 and more than 80 in 2013. Customs and forensic laboratories are faced with a challenge in identifying the chemical structure of these new compounds. Their analytical controls based on infrared spectroscopy and gas chromatography-mass spectrometry allow the recognition of known substances already recorded in spectroscopic libraries. However the identification of new derivatives as well as new chemical structures requires highly sophisticated analytical techniques such as Nuclear Magnetic Resonance (NMR) and High Resolution Mass Spectrometry (HR-MS). The report introduces an analytical strategy allowing the characterisation of unknown compounds based on the experience of the JRC in the use of these techniques. These approaches have been tested in the laboratory of the Joint Research Centre (JRC) and the efficiency of the proposed approach has been successfully demonstrated on several study cases. The report gives an overview of the analytical strategies and modern laboratory techniques needed to perform a fast unambiguous identification and characterisation of unknown organic chemical substances such as New Psychoactive Substances (NPS).JRC.I.1-Chemical Assessment and Testin

Systematic analytical characterization of new psychoactive substances: A case study

AbstractNew psychoactive substances (NPS) are synthesized compounds that are not usually covered by European and/or international laws. With a slight alteration in the chemical structure of existing illegal substances registered in the European Union (EU), these NPS circumvent existing controls and are thus referred to as “legal highs”. They are becoming increasingly available and can easily be purchased through both the internet and other means (smart shops). Thus, it is essential that the identification of NPS keeps up with this rapidly evolving market.In this case study, the Belgian Customs authorities apprehended a parcel, originating from China, containing two samples, declared as being “white pigments”. For routine identification, the Belgian Customs Laboratory first analysed both samples by gas-chromatography mass-spectrometry and Fourier-Transform Infrared spectroscopy. The information obtained by these techniques is essential and can give an indication of the chemical structure of an unknown substance but not the complete identification of its structure. To bridge this gap, scientific and technical support is ensured by the Joint Research Centre (JRC) to the European Commission Directorate General for Taxation and Customs Unions (DG TAXUD) and the Customs Laboratory European Network (CLEN) through an Administrative Arrangement for fast recognition of NPS and identification of unknown chemicals. The samples were sent to the JRC for a complete characterization using advanced techniques and chemoinformatic tools.The aim of this study was also to encourage the development of a science-based policy driven approach on NPS.These samples were fully characterized and identified as 5F-AMB and PX-3 using 1H and 13C nuclear magnetic resonance (NMR), high-resolution tandem mass-spectrometry (HR-MS/MS) and Raman spectroscopy. A chemoinformatic platform was used to manage, unify analytical data from multiple techniques and instruments, and combine it with chemical and structural information

Chemical exposure : european citizens’ perspectives, trust, and concerns on human biomonitoring initiatives, information needs, and scientific results

Copyright: © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).Over the last few decades, citizen awareness and perception of chemical products has been a topic of interest, particularly concerning national and international policy decision makers, expert/scientific platforms, and the European Union itself. To date, few qualitative studies on human biomonitoring have analysed communication materials, made recommendations in terms of biomonitoring surveillance, or asked for feedback in terms of specific biomonitoring methods. This paper provides in-depth insight on citizens’ perceptions of knowledge of biomonitoring, impact of chemical exposure on daily life, and claims on how results of research should be used. Four semi-structured focus groups were held in Austria, Portugal, Ireland, and the United Kingdom (UK). The cross-sectional observational qualitative design of this study allows for better understanding of public concern regarding chemicals, application, and use of human biomonitoring. The main findings of this study include citizens’ clear articulation on pathways of exposure, the demand on stakeholders for transparent decision-making, and sensitivity in communication of results to the public. Validated and trustful communication is perceived as key to empowering citizens to take action. The results can be used to facilitate decision-making and policy development, and feeds into the awareness needs of similar and future projects in human biomonitoring. Furthermore, it also brings to light ideas and concepts of citizens’ in shaping collaborative knowledge between citizens’, experts, scientists, and policy makers on equal terms.The HBM4EU project received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 73303info:eu-repo/semantics/publishedVersio

Consultation on a sustainable HBM initiative in Europe - Deliverable Report D6.3 WP6 Sustainability and Capacity building.

This deliverable was produced under Task 6.3 of Work Package 6 on “Longer-term needs and expectations of stakeholders (2021-2030)”. The aim of this task was to gather information on the needs and expectations of both the National Hubs (NH) and a broad range of stakeholders regarding a long-term Human Biomonitoring (HBM) programme for Europe, to be establish in follow up to the current project, HBM4EU. Firstly and with a focus on options for financing a future initiative, information was collected on a range of available funding mechanisms at national, regional and international level. In terms of national funding, the results presented rely on responses to a survey with the NH. Unfortunately, the response from NHs was very limited, and as such the report only captures funding mechanisms from a limited number of countries, including Portugal, Spain, France, Germany and Cyprus. In order to gain insight into the status of the National Hubs and their capacities for HBM, a survey was conducted. The results provide an overview of the current situation across the NHs with regards to a range of aspects, including the level of activity of the NH, status of political support, availability of funding, ongoing HBM studies and willingness to align studies with HBM4EU. The results suggest that HBM4EU has raised the political profile of HBM in partner countries. Regarding ongoing HBM studies, only six countries have national HBM programmes, with most countries having only hot spot studies. Despite this, there was support for the alignment of studies to achieve European geographical coverage. Regarding funding, access to European funding is seen as important to leverage funds at national level. A second survey was targeted at a wide range of stakeholders, aiming to better understand their expectations for a long-term sustainable HBM initiative. The survey was followed by a workshop, where a more limited number of stakeholders had the opportunity to discuss the survey results and address such aspects as the scope of a future initiative, how to achieve financial sustainability, how to involve and how a future initiative might contribute to chemical policies. Concerning the needs and expectations of stakeholders, there is a strong interest in and support for a future HBM initiative at European level. The involvement of a European Union (EU) institution as part of a future steering committee was seen as crucial. According to this stakeholders’ consultation, the initiative should focus on protecting human health and the environment in Europe from hazardous chemical exposures by producing harmonised, high quality, transparent and inclusive data for effective risk assessment and management.HBM4EU - Grant agreement 733032 HORIZON 2020 Programmeinfo:eu-repo/semantics/publishedVersio

WP6 - Sustainability and Capacity building

This report aims to provide a revision on the national needs (T6.1), the funding mechanisms (T6.2) and the long-term sustainability of HBM4EU (T6.3). Therefore, this report is divided in the three above-mentioned sections, for which the different tasks within work package 6 (WP 6) provided input. Concerning national needs, a survey is conducted annually by the national hub (NH) coordinator to monitor and evaluate the progress and development of all National Hubs involved in HBM4EU. With 2020 being the fourth year of the HBM4EU project, the survey followed many of the questions of previous years. Most NHs are satisfied with their current HBM4EU involvement, but have expressed their concerns regarding the communication, funding and lack of direct involvement. The follow-up to HBM4EU, PARC, was mentioned and the necessary involvement of all countries as well as the importance of communication between NHs and National Hub Contact Points (NHCPs) was highlighted. Inclusivity of smaller countries seems to be a problem through both lack of funding and adequate tasks. Regarding funding mechanisms, the initial list of financing mechanisms in the HBM and environmental health area at national and international level was updated and is available on the HBM4EU website under the “Funding Opportunities” tab. This intends to be an inventory that can be used not only by the HBM4EU consortium but by the entire scientific community to provide an overview of existing funding sources. It comprises of a set of targeted strategies for identification and dissemination of funding which are explained in further detail in section 6 Funding mechanisms. A systematic literature review was also undertaken to understand what the primary funding source of projects in HBM was. The results are not available yet. As part of T6.3 on the long-term sustainability, a citizen survey was developed together with T4.1 – mapping of needs. This survey was initially used for focus groups to better understand their awareness and concerns of chemical exposure and Human Biomonitoring. It was updated to harvest more EU-wide results including chemical exposure during the COVID-19 pandemic. The survey took place between September 2020 and February 2021 and the results were organised to cover the same regions as the aligned studies to allow for the organisation of results in a similar way for coherence. In order to produce a short report summarising the outcome of the survey, the questions were grouped for quicker analysis. The majority of the respondents considers HBM a tool that produces important results on human exposure to chemicals and that it should be performed more often and in a more coordinated way. This was a non-representative survey and future work should focus on wider dissemination in other population groups and on understanding how perceptions change over time. The survey’s answers were also distributed to the NHs, so they can produce internal communication briefs on their own data for further dissemination.HORIZON2020 Programme Contract No. 733032 HBM4EU.info:eu-repo/semantics/publishedVersio

Portuguese population’s perceptions on Human Biomonitoring according to the HBM4EU citizen survey

No âmbito da Iniciativa Europeia em Biomonitorização Humana (HBM4EU) foi realizado um inquérito dirigido aos cidadãos europeus que pretendia recolher informação acerca das suas opiniões e perceções sobre a exposição a substâncias químicas, bem como sobre o que é a biomonitorização humana (BMH), por que é que ela é importante e qual o seu papel na saúde. Em Portugal responderam ao inquérito 669 indivíduos, a maioria do sexo feminino, com ensino superior e empregados. A maioria dos participantes portugueses considera que a BMH é uma atividade que deve ser realizada regularmente e de forma coordenada. Os participantes também consideram que os estudos de BMH são muito relevantes para várias atividades, desde a avaliação do impacto da exposição às substâncias químicas, ao apoio de políticas de saúde ocupacional. As áreas indicadas como uma prioridade para os estudos de BMH revelaram uma maior preocupação com a exposição por via alimentar.In the scope of the European Human Biomonitoring Initiative, a survey directed to all the European citizens was launched to collect information on their opinions and perceptions on exposure to chemicals and human biomonitoring (HBM). In Portugal, 669 individuals have answered the survey, the majority being female, with high educational level and having a job. The majority of the Portuguese survey participants considers that HBM is an activity that should be performed regularly and in a coordinated way. The participants also consider that HBM surveys are relevant to several activities from the evaluation of the impact of exposure to chemicals to the support of occupational health policies. The areas indicated as a priority to the HBM surveys have revealed a bigger concern with exposure through food.O projeto HBM4EU foi cofinanciado pelo programa de investigação e inovação Horizonte 2020 da União Europeia, ao abrigo da convenção de subvenção n.º 733032, e pelas instituições nacionais parceiras do projetoinfo:eu-repo/semantics/publishedVersio

HERA - Environmental Risk Assessment of a contaminated estuarine environment: a case study

Sado River estuary is located in the west coast of Portugal. Previous environmental studies identified industrial contamination, non-point anthropogenic sources and contamination coming from the river, all promoting accumulation of polluted sediments with known impacts on the ecological system. Surrounding human populations have intense economic fishery activities. Together with agriculture, estuary fishing products are available to local residents. Food usage previously characterized through ethnographic studies suggests exposure to estuarine products, farming products, and water in daily activities, as potential routes of contamination. It is well established that long term exposure to heavy metals are associated with renal and neurological diseases, most heavy metals are classified as carcinogenic and teratogenic.Instituição Financiadora: FCT; Instituições participantes: IMAR -Instituto do Mar (coord.)e PRÓ-INSA, Associação para a Promoção da Investigação em Saúde, Instituto Nacional de Saúde Doutor Ricardo Jorg

Developing human biomonitoring as a 21st century toolbox within the European exposure science strategy 2020-2030

Human biomonitoring (HBM) is a crucial approach for exposure assessment, as emphasised in the European Commission’s Chemicals Strategy for Sustainability (CSS). HBM can help to improve chemical policies in five major key areas: (1) assessing internal and aggregate exposure in different target populations; 2) assessing exposure to chemicals across life stages; (3) assessing combined exposure to multiple chemicals (mixtures); (4) bridging regulatory silos on aggregate exposure; and (5) enhancing the effectiveness of risk management measures. In this strategy paper we propose a vision and a strategy for the use of HBM in chemical regulations and public health policy in Europe and beyond. We outline six strategic objectives and a roadmap to further strengthen HBM approaches and increase their implementation in the regulatory risk assessment of chemicals to enhance our understanding of exposure and health impacts, enabling timely and targeted policy interventions and risk management. These strategic objectives are: 1) further development of sampling strategies and sample preparation; 2) further development of chemical-analytical HBM methods; 3) improving harmonisation throughout the HBM research life cycle; 4) further development of quality control / quality assurance throughout the HBM research life cycle; 5) obtain sustained funding and reinforcement by legislation; and 6) extend target-specific communication with scientists, policymakers, citizens and other stakeholders. HBM approaches are essential in risk assessment to address scientific, regulatory and societal challenges. HBM requires full and strong support from the scientific and regulatory domain to reach its full potential in public and occupational health assessment and in regulatory decision-making.info:eu-repo/semantics/publishedVersio

EU-wide exposure data of 11 chemical substance groups from the HBM4EU Aligned Studies (2014–2021)

Funding Information: The authors would like to thank everybody who contributed to the HBM4EU Aligned Studies: the participating children, teenagers, adults and their families, the fieldworkers that collected the samples and database managers that made the information available to HBM4EU, the HBM4EU project partners, especially those from WP7 for developing all materials supporting the fieldwork, WP9 for organizing the QA/QC scheme under HBM4EU and all laboratories who performed the analytical measurements. We would like to acknowledge Sun Kyoung Jung from the National Institute of Environmental Research of South-Korea for providing the KoNEHS Cycle III results (crt adjusted). HBM4EU is co-financed under Horizon 2020 (grant agreement No 733032). The authors thank all principal investigators of the contributing studies for their participation and contribution to the HBM4EU Aligned Studies and the national program owners for their financial support. Further details on funding for all the participating studies can be found in the Supplemental Material, Table S12.As one of the core elements of the European Human Biomonitoring Initiative (HBM4EU) a human biomonitoring (HBM) survey was conducted in 23 countries to generate EU-wide comparable HBM data. This survey has built on existing HBM capacity in Europe by aligning national or regional HBM studies, referred to as the HBM4EU Aligned Studies. The HBM4EU Aligned Studies included a total of 10,795 participants of three age groups: (i) 3,576 children aged 6–12 years, (ii) 3,117 teenagers aged 12–18 years and (iii) 4,102 young adults aged 20–39 years. The participants were recruited between 2014 and 2021 in 11–12 countries per age group, geographically distributed across Europe. Depending on the age group, internal exposure to phthalates and the substitute DINCH, halogenated and organophosphorus flame retardants, per- and polyfluoroalkyl substances (PFASs), cadmium, bisphenols, polycyclic aromatic hydrocarbons (PAHs), arsenic species, acrylamide, mycotoxins (deoxynivalenol (total DON)), benzophenones and selected pesticides was assessed by measuring substance specific biomarkers subjected to stringent quality control programs for chemical analysis. For substance groups analyzed in different age groups higher average exposure levels were observed in the youngest age group, i.e., phthalates/DINCH in children versus teenagers, acrylamide and pesticides in children versus adults, benzophenones in teenagers versus adults. Many biomarkers in teenagers and adults varied significantly according to educational attainment, with higher exposure levels of bisphenols, phthalates, benzophenones, PAHs and acrylamide in participants (from households) with lower educational attainment, while teenagers from households with higher educational attainment have higher exposure levels for PFASs and arsenic. In children, a social gradient was only observed for the non-specific pyrethroid metabolite 3-PBA and di-isodecyl phthalate (DiDP), with higher levels in children from households with higher educational attainment. Geographical variations were seen for all exposure biomarkers. For 15 biomarkers, the available health-based HBM guidance values were exceeded with highest exceedance rates for toxicologically relevant arsenic in teenagers (40%), 3-PBA in children (36%), and between 11 and 14% for total DON, Σ (PFOA + PFNA + PFHxS + PFOS), bisphenol S and cadmium. The infrastructure and harmonized approach succeeded in obtaining comparable European wide internal exposure data for a prioritized set of 11 chemical groups. These data serve as a reference for comparison at the global level, provide a baseline to compare the efficacy of the European Commission's chemical strategy for sustainability and will give leverage to national policy makers for the implementation of targeted measures.publishersversionpublishe

Harmonized human biomonitoring in European children, teenagers and adults: EU-wide exposure data of 11 chemical substance groups from the HBM4EU Aligned Studies (2014–2021)

HBM4EU is co-financed under Horizon 2020 (grant agreement No 733032).As one of the core elements of the European Human Biomonitoring Initiative (HBM4EU) a human biomonitoring (HBM) survey was conducted in 23 countries to generate EU-wide comparable HBM data. This survey has built on existing HBM capacity in Europe by aligning national or regional HBM studies, referred to as the HBM4EU Aligned Studies. The HBM4EU Aligned Studies included a total of 10,795 participants from three age groups: (i) 3,576 children aged 6-12 years, (ii) 3,117 teenagers aged 12-18 years, and (iii) 4,102 young adults aged 20-39 years. The participants were recruited between 2014 and 2021 in 11-12 countries per age group, geographically distributed across Europe. Depending on the age group, internal exposure to phthalates and the substitute DINCH, halogenated and organophosphorus flame retardants, per- and polyfluoroalkyl substances (PFASs), cadmium, bisphenols, polycyclic aromatic hydrocarbons (PAHs), arsenic species, acrylamide, mycotoxins (deoxynivalenol (total DON)), benzophenones and selected pesticides was assessed by measuring substance specific biomarkers subjected to stringent quality control programs for chemical analysis. For substance groups analyzed in different age groups higher average exposure levels were observed in the youngest age group, i.e., phthalates/DINCH in children versus teenagers, acrylamide and pesticides in children versus adults, and benzophenones in teenagers versus adults. Many biomarkers in teenagers and adults varied significantly according to educational attainment, with higher exposure levels of bisphenols, phthalates, benzophenones, PAHs, and acrylamide in participants (from households) with lower educational attainment, while teenagers from households with higher educational attainment have higher exposure levels for PFASs and arsenic. In children, a social gradient was only observed for the non-specific pyrethroid metabolite 3-PBA and di-isodecyl phthalate (DiDP), with higher levels in children from households with higher educational attainment. Geographical variations were seen for all exposure biomarkers. For 15 biomarkers, the available health-based HBM guidance values were exceeded with the highest exceedance rates for toxicologically relevant arsenic in teenagers (40%), 3-PBA in children (36%), and between 11 and 14% for total DON, Σ (PFOA + PFNA + PFHxS + PFOS), bisphenol S and cadmium. The infrastructure and harmonized approach succeeded in obtaining comparable European-wide internal exposure data for a prioritized set of 11 chemical groups. These data serve as a reference for comparison at the global level, provide a baseline to compare the efficacy of the European Commission's chemical strategy for sustainability, and will give leverage to national policymakers for the implementation of targeted measures.info:eu-repo/semantics/publishedVersio