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

European Parliament Pilot Project on Exposure to Indoor air Chemicals and Possible Health Risks

This report outlines the results of the 2-year pilot project on indoor air quality and potential health effects executed by the Joint Research Centre and funded by the European Parliament via the Directorate-General Health and Consumer Protection. It had four distinct objectives as follows: 1) to identify and quantify the main air pollutants present in public buildings, including indoor environments where children frequently stay, like schools and kindergartens, 2) to identify the main sources of these pollutants, applying source apportionment analyses, 3) to estimate people¿s exposure to these pollutants while working and/or living in these areas and combined with micro-environmental activity patterns during the day, 4) to evaluate possible health risks due to (chronic) exposure to air pollutants, in particular, for children. The results indicate that indoor air pollution concentrations are consistently higher than the respective outdoor ones for the chemical families this study focused on. Differences attributable to variation in consumer behaviour, climate and type of building materials used, have been identified in the indoor:outdoor ratio of primary pollutants across Europe. These differences account for small variance in the corresponding health risk to the local population across the EU.JRC.I.5-Physical and chemical exposure

Migration of Polycyclic Aromatic Hydrocarbons (PAHs) from plastic and rubber articles

Polycyclic Aromatic Hydrocarbons (PAHs) constitute a large group of chemically related substances many of which are known carcinogens. To minimise human exposure there are already several pieces of EU legislation which limit their presence in certain food products, as well as in water and ambient air. Under the REACH regulation (EC 1907/2006 Annex XVII, Entry 50), eight priority PAHs have for some time been restricted in extender oils used in tyres. Although not added deliberately to consumer products, PAHs can still be present as impurities. An amendment of the above mentioned legislation (Regulation EU 1272/2013) establishes content limits for the eight PAHs of 0.5 mg kg-1 for plastic and rubber components of toys/childcare articles, and 1 mg kg-1 for all other consumer articles, in direct and prolonged, or short-term repetitive, contact with the skin or oral cavity. In May 2016 DG JRC and DG GROW signed an Administrative Arrangement (AA 34003) known as the STANPAHs project. The main objective of this contract was for the JRC to provide scientific support in the implementation and potential amendment of the restriction on polycyclic aromatic hydrocarbons, in particular concerning paragraphs 5 and 6 of entry 50 of Annex XVII to the REACH legislation. The main objectives of the project were: a) to gain a better understanding of the migration behaviour of certain PAHs in plastic and rubber components of articles, and b) to develop a reliable methodology to determine PAH migration from these matrices, under conditions simulating, to the best possible extent, dermal contact (including the oral cavity). This report presents the outcomes of the experimental studies carried out at JRC and the achievements towards fulfilling these objectives. A set of manufactured polymeric plastic and rubber matrices, to be used as test materials in the project, has been chosen based on criteria such as their frequency of use in articles within the scope of the restriction and the likelihood of the presence of high PAH contents (e.g. due to their content in carbon black or extender oils). Various grades and types of ingredients known to be PAH sources were used in the formulation of the manufactured ad-hoc materials. The test materials included low density polyethylene (LDPE), polystyrene (PS) and polyvinyl chloride (PVC) as plastic matrices, and ethylene-propylene diene monomer (EPDM), natural rubber-butadiene rubber (NR-BR) and silicone as rubber matrices. Moreover, recycled granules (coated and uncoated) originating from end-of-life tyres produced before and after 2010 as well as rubber tiles made of the recycled coated granules were also made available for this study. The content of each of the eight restricted PAHs was measured by using a method developed in-house based on Randall hot extraction, purification by Solid Phase Extraction based on Molecular Imprinted Polymers, and Gas Chromatography Mass Spectrometry determination. A number of experimental studies were undertaken to generate data and information to improve the knowledge on migration of the target PAHs. Migration parameters operated in the STANPAHs project to estimate migration rates were as follows: dynamic mode at 40°C for 24 hours using a variety of migration media including artificial aqueous simulants, modified biosimulants formulations with lipidic content such as skin surface film liquid (SSFL), and 20% ethanol in water. According to scientific literature the use of 20% ethanol as the migration medium proved to correlate well with human skin absorption. Using these conditions, migration of the target PAHs into artificial sweat (EN1811) and artificial saliva (DIN53160-1) was not detected in any of the materials studied. Moreover none of the plastic polymeric materials led to detectable release of the target PAHs in any of the migration media used in this study (i.e. artificial sweat and saliva, skin surface film liquid (SSFL), and 20% ethanol solution). Similarly the tests with silicone materials did not result in detectable migration. Only the rubber matrices containing Distillate Aromatic Extract (DAE) as extender oil showed detectable migration when using 20% ethanol as the migration solution. In addition, the release of PAHs from coated recycled rubber granules was lower than from the uncoated granules suggesting that the coating acts as a barrier to chemical migration. According to industrial partners DAE is not used by European industries for manufacturing of parts of articles intended for skin contact. The materials containing DAE, although not representative for marketed products, have been made available to facilitate migration testing method development. The migration test method using 20% ethanol has been validated in-house and shows good method performance allowing the determination of PAH at trace level. Furthermore it has been considered for an initial inter-laboratory comparison study (ILC) aiming to investigate method applicability and transferability in a variety of laboratories. The within-laboratory precision, expressed as the relative standard deviation for repeatability (RSDr), and the between-laboratory precision, expressed as the relative standard deviation for reproducibility (RSDR) were assessed. In general the RSDR ranged from 28 to 113% and the RSDr from 7 to 23%. It is worth remembering that the level of PAH migration was very close to the quantification limit of the method and therefore this variability can be expected. Similar values have been reported in a recent German study with the participation of 9 laboratories on the migration of PAHs from rubber materials in contact with aqueous ethanol. The fact that better values of RSDr and RSDR were obtained for chrysene and benzo(e)pyrene that had the highest concentrations in the final migration solutions and that the analysis of the control solution used in this exercise showed a good reproducibility (RSDR% <10%), shows the possibility to reduce the variability between laboratories with a revised operating procedure in terms of injection volume and/or elution volume. In conclusion this report makes available new data and scientific information on the migration behaviour of certain PAHs from selected plastic and rubber polymeric matrices, in support of the European Commission's legal obligation to review the PAHs restriction under REACH. Standard operating procedures for quantification of the content of each of the eight restricted PAHs as well as their migration into 20% ethanol have been developed. Moreover the information gathered in STANPAHs (e.g. literature search), the ad-hoc manufactured materials still available, as well as the JRC in-house analysis method for PAH content could be of great benefit to accelerate the work towards standardisation of PAH content analysis in consumer products that has been recently undertaken by the European Standardisation Committee following a request by DG GROW.JRC.F.2-Consumer Products Safet

Cybersecurity, our digital anchor: A European perspective

The Report ‘Cybersecurity – Our Digital Anchor’ brings together research from different disciplinary fields of the Joint Research Centre (JRC), the European Commission's science and knowledge service. It provides multidimensional insights into the growth of cybersecurity over the last 40 years, identifying weaknesses in the current digital evolution and their impacts on European citizens and industry. The report also sets out the elements that potentially could be used to shape a brighter and more secure future for Europe’s digital society, taking into account the new cybersecurity challenges triggered by the COVID-19 crisis. According to some projections, cybercrime will cost the world EUR 5.5 trillion by the end of 2020, up from EUR 2.7 trillion in 2015, due in part to the exploitation of the COVID-19 pandemic by cyber criminals. This figure represents the largest transfer of economic wealth in history, more profitable than the global trade in all major illegal drugs combined, putting at risk incentives for innovation and investment. Furthermore, cyber threats have moved beyond cybercrime and have become a matter of national security. The report addresses relevant issues, including: - Critical infrastructures: today, digital technologies are at the heart of all our critical infrastructures. Hence, their cybersecurity is already – and will become increasingly – a matter of critical infrastructure protection (see the cases of Estonia and Ukraine). - Magnitude of impact: the number of citizens, organisations and businesses impacted simultaneously by a single attack can be huge. - Complexity and duration of attacks: attacks are becoming more and more complex, demonstrating attackers’ enhanced planning capabilities. Moreover, attacks are often only detected post-mortem . - Computational power: the spread of malware also able to infect mobile and Internet of Things (IoT) devices (as in the case of Mirai botnet), hugely increases the distributed computational power of the attacks (especially in the case of denial of services (DoS)). The same phenomenon makes the eradication of an attack much more difficult. - Societal aspects: cyber threats can have a potentially massive impact on society, up to the point of undermining the trust citizens have in digital services. As such services are intertwined with our daily life, any successful cybersecurity strategy must take into consideration the human and, more generally, societal aspects. This report shows how the evolution of cybersecurity has always been determined by a type of cause-and-effect trend: the rise in new digital technologies followed by the discovery of new vulnerabilities, for which new cybersecurity measures must be identified. However, the magnitude and impacts of today's cyber attacks are now so critical that the digital society must prepare itself before attacks happen. Cybersecurity resilience along with measures to deter attacks and new ways to avoid software vulnerabilities should be enhanced, developed and supported. The ‘leitmotiv’ of this report is the need for a paradigm shift in the way cybersecurity is designed and deployed, to make it more proactive and better linked to societal needs. Given that data flows and information are the lifeblood of today’s digital society, cybersecurity is essential for ensuring that digital services work safely and securely while simultaneously guaranteeing citizens’ privacy and data protection. Thus, cybersecurity is evolving from a technological ‘option’ to a societal must. From big data to hyperconnectivity, from edge computing to the IoT, to artificial intelligence (AI), quantum computing and blockchain technologies, the ‘nitty-gritty’ details of cybersecurity implementation will always remain field-specific due to specific sectoral constraints. This brings with it inherent risks of a digital society with heterogeneous and inconsistent levels of security. To counteract this, we argue for a coherent, cross-sectoral and cross-societal cybersecurity strategy which can be implemented across all layers of European society. This strategy should cover not only the technological aspects but also the societal dimensions of ‘behaving in a cyber-secure way’. Consequently, the report concludes by presenting a series of possible actions instrumental to building a European digital society secure by design.JRC.E.3-Cyber and Digital Citizens' Securit

Valutazione dell'Esposizione Totale a Benzene e Formaldeide nei Paesi Europei

see attachedJRC.I.5-Physical and chemical exposure

Chemical Emissions from Toys - The Case of Stink Blasters

In the last years several communications to the Rapid Alarm System for non food products (RAPEX) were issued1 concerning the presence of cyclohexanone in stink blasters (toys emitting characteristic smell after squeezing) and its possible impact on human health. The scope of the present study was to identify and quantify the emission of volatile organic compounds (VOCs) from this kind of toys and to evaluate possible health risks, in particular for children. Although the stink blasters are intended for outdoor use, a hypothetical indoor use (e.g. use by children in closed environments) has been considered relevant for exposure assessment studies. Specimens for testing were bought in a local market and are similar to the products mentioned in the RAPEX notification. The toys analyzed (following extraction with methanol) contain less than 0.2% by weight of cyclohexanone. Cyclohexanone was found in the sponge and the head of the toy (causing the characteristic smell, when squeezed) but also in the body. In addition to these preliminary experiments and in order to evaluate air exposure to cyclohexanone, the stink blasters were placed in the Indoortron facility, a walk-in type environmental chamber of 30 m3 volume featuring automatic control of parameters such as temperature (T), relative humidity (RH) and air change rates (ach), and tested for emissions after squeezing several times under ¿real world setting¿ conditions (22 C, 50% RH, 0.5 ach). By this, the main compounds emitted were cyclohexanone and toluene with concentrations reaching values to 25 ug/m3 and 32 ug/m3 respectively. These concentrations are much lower than the indicative occupational exposure limit values of 40 mg/m3 for cyclohexanone and 192 mg/m3 for toluene2. However, within the frame of this study it is not possible to evaluate possible health effects, which might be expected from a chronic exposure to the aforementioned chemicals at low doses. [1] Rapex archive at: http://ec.europa.eu/consumers/dyna/rapex/create_rapex.cfm?rx_id=23 [2] Commission Directive 2006/15/EC establishing a second list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC amending Directives 91/322/EEC and 2000/39/EC of 7 February 2006JRC.I.2-Chemical assessment and testin

Chemical emissions from toys - the case of stink blasters

The aim of the present study was to characterise and quantify the emissions of volatile organic compounds that can be released into the air from stink blasters (a toy in human shape that releases malodorous substances after squeezing the head) and to evaluate possible health risks, particularly for children. Although the stink blasters are intended for outdoor use, a hypothetical indoor use (e.g. a child¿s room) has been considered relevant for exposure assessment studies. The emissions of the items were investigated in environmental chambers and their content was assessed by chemical extraction. In addition to these preliminary experiments and in order to evaluate airborne exposure to cyclohexanone, the stink blasters were placed in the Indoortron facility, a 30m3 volume walk-in type environmental chamber, and tested for emissions after squeezing several times under ¿real world setting¿ conditions (23C, 50% relative humidity, 0.5 air changes per hour). The amount of chemicals released was determined by applying two different techniques and time series analysis of the air inside the chamber sampled on Tenax TA tubes and DNPH cartridges, followed by thermal desorption gas chromatography mass spectrometry and HPLC¿UV, respectively. The main resulting compounds emitted were cyclohexanone and toluene, with concentrations reaching values of 25 and 32 mgm3, respectively. These levels are much lower than established permissible exposure limits. Measured toluene levels are also below the chronic inhalation reference limit value (300 mgm3) set for this compound by the California Environmental Protection Agency (Cal EPA). However, such a value is not set for cyclohexanone, so attention should be given to chronic exposures at low concentration levels, in particular for sensitive sub-groups such as children.JRC.I.2-Chemical assessment and testin

Chemical Emissions from Toys - the Case of Stink Blasters

The present study was conducted to characterise and quantify the emission of volatile organic compounds (VOCs) that can be released into the air from stink blasters, a particular toy with human shape that releases malodorous substances after squeezing the head, and to evaluate possible health risks, in particular for children. Several notifications to the Rapid Alarm System for Non Food Products (RAPEX) were issued for the presence of cyclohexanone, a neurotoxic compound, in stink blasters. RAPEX is a system for the rapid exchange of information within the European Union on the dangers arising from consumer products, used by member states to communicate products that do not comply with EU legislation. Although the stink blasters are intended for outdoor use, a hypothetical indoor use (e.g. a child¿s room) has been considered relevant for exposure assessment studies. The emissions of the items were investigated in environmental chambers and their content by chemical extraction. In addition to these preliminary experiments and in order to evaluate air exposure to cyclohexanone, the stink blasters were placed in the Indoortron facility, a 30m3 volume walk-in type environmental chamber, and tested for emissions after squeezing several times under ¿real world setting¿ conditions (23°C, 50% RH, 0.5 ach). The amount of chemicals released were determined by comparison of two different techniques by time series analysis of the air inside the chamber sampled on Tenax TA tube and DNPH cartridges, followed by thermal desorption combined with analysis by gas chromatography mass spectrometry and HPLC-UV respectively. The resulting main compounds emitted were cyclohexanone and toluene, with concentrations reaching values of 25 mg/m3 and 32 mg/m3 respectively. However, within the frame of this study it is not possible to evaluate possible health effects which might be expected from a chronic exposure to the aforementioned chemicals at low doses.JRC.I.2-Chemical assessment and testin

Exposure to Particulate Matter in Vehicle Cabins of Private Cars

A growing number of studies indicate the significance of short-term exposures to airborne particulate matter, such as those occurring in a vehicle cabin. In this study, PM10, PM2,5, PM1 concentrations were measured using optical particle counters in eighteen tobacco smoke-free private cars in movement. The average concentrations were 48.6 µg m-3, 26.9 µg m-3 and 22.6 µg m-3 for PM10, PM2,5 and for PM1, respectively. These levels were found to depend directly on the ambient air PM concentration and the choice of ventilation used inside the cars. The average number of particles with a diameter > 0.3 µm measured in the cabins of the cars was 185,723 particles per litre. The average number of particles with a diameter between 0.02-1 µm was 16,391 particles per cm3. Concentrations were found to partly exceed the established limit values for ambient air. Thus, the time spent driving a vehicle might significantly contribute to the daily overall exposure to particulate matter, especially in the case of some groups of professional workers.JRC.DG.I.2-Chemical assessment and testin