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To fulfil the European Green Deal targets and implement a circular economy, there is an urgent need to increase recycling rates of packaging materials. However, before recycled materials can be used in food contact applications, they must meet high safety standards. According to the European Food Safety Authority (EFSA), a worst-case scenario must be applied and unknown substances must be evaluated as being potentially genotoxic. The Ames test, which detects direct DNA-reactive effects, together with chromatographic analysis is very promising to complement risk assessment. This study aims to evaluate the effectiveness of functional barriers in ten different samples, including virgin and recycled LDPE foils. FT-IR analysis did not show major differences between virgin and recycled films. Light microscopy revealed differences in quality and an increased number of particles. GC-MS analysis detected and quantified 35 substances, including eight unknowns. Using a miniaturized version of the Ames test, four of ten samples tested positive in two individual migrates up to a dilution of 12.5%. All virgin LDPE materials tested negative; however, recycled material F showed an increased mutagenic activity, with an n-fold induction up to 28. Samples with functional barriers lowered migration and reduced mutagenicity. Nonetheless, further investigations are needed to identify possible sources of contamination. [ABSTRACT FROM AUTHOR]

Council Regulation (EU) 2019/1111, recently entered into force, brought significant progress for EU Member States in the specific area of international child abductions. In the context of freedom of movement within the European Union guaranteed by art. 21 TFEU, there is an ever-increasing number of transnational families, and an equally increasing risk of international child abductions when these families break up. Strongly supporting the general principle according to which an abducted child shall promptly be returned to the state of habitual residence, Council Regulation (EU) 2019/1111 narrows the application of the most frequently encountered exception to this principle, namely the “grave risk” exception. The purpose of the article is to analyse the child protection measures ensuring the application of the principle of prompt return, even when a serious risk is associated with the return of the child to the state of habitual residence. Hence, the objectives of the present study are to identify the progress from private international law to EU law, and also the way in which the relevant EU regulations - Council Regulation (EC) 2201/2003 and Council Regulation (EU) 2019/1111 - have constantly evolved in relation to protection measures, intended to remove from application the serious risk defense. Moreover, as these protective measures are not indicated even by the actual Council Regulation (EU) 2019/1111, the article will further examine the most significant procedural and substantive aspects, as they arise from legislation in force and the case-law of the courts in Member States.

The relevance of this work stems from the necessity to make informed government decisions aimed at strengthening the innovation ecosystem and its entrepreneurial component as the foundation for the recovery of the Ukrainian economy and overcoming its structural and technological backwardness. This requires the production of high quality and reliable statistical data that conform to the best practices of the European Union. The article delineates the institutional framework for adapting Ukraine's state statistics in the field of innovation to the requirements of European standards. The results show that the national statistical methodology for assessing innovation activities of enterprises generally complies with EU regulations and recommendations. However, the suspension of publication of current statistical information during the period of martial law prevents an assessment of all components of the quality of the respective state statistical observation for accuracy, consistency, comparability, and comprehensibility of statistical data. Furthermore, the article elucidates the specific aspects of the EU tools employed to assess national and regional innovation ecosystems and their entrepreneurial component, in particular, the European Innovation Scoreboard (EIS) and the Regional Innovation Scoreboard (RIS). It outlines the characteristics of individual EIS indicators that are outside the scope of state statistics in 2023 and assesses the capacity of the State Statistics Service to measure them. Among these indicators, those that were duplicated in another, more comprehensive EU toolkit for assessing the digital performance of Europe-the Digital Economy and Society Index (DESI)-were identified. Following a Ukrainian government decree, these indicators will be collected and published annually starting in 2025. Finally, the article outlines the conditions for the inclusion of Ukrainian regions in the RIS, which will be facilitated by the adopted statistical classification of territorial units of Ukraine (NUTS-UA). [ABSTRACT FROM AUTHOR]

Ethoxyquin (EQ), is a quinolone which was commonly used as an antioxidant additive and a fungicide. EQ is the most effective antioxidant additive for protecting fishmeal during transport and storage, as well as food for companion animals. However, this compound has rised reasonable doubts regarding the safety of its use. Ethoxyquin was authorised in the EU as a feed additive for all animal species and categories until 2017, for its antioxidant properties. EFSA has issued two negative opinions due to insufficient data on the safety of EQ and its transformation products and to para-phenetidine, used for the synthesis of EQ. In June 2017, the European Commission suspended the authorisation of EQ as a feed additive for all animal species, (Regulation (EU) 2017/962). This article presents the history of the use of EQ, its impact on animals health and the reasons for suspending its use as a feed additive in the European Union. [ABSTRACT FROM AUTHOR]

This paper aims to describe and motivate the author’s perspective on the issues posed by robotics and Artificial Intelligence, exploring the significance of the Fundamental Rights approach to AI. The author believes both aspects are essential for understanding robotics, work empowerment, and the environment. The Fundamental Rights approach helps concentrate the attention on the issue of the environment, intended as the social environment, which is strictly linked to legal sustainability.

Ionic liquids (IL) are innovative alternative solvents to recover bioactive compounds from plant-based sources to replace toxic volatile organic solvents (VOS). ILs are tailored-made solvents with chemical and thermal stabilities, nonvolatile and noninflammable. Although ILs are versatile, cost-effective, and sustainable solutions, the European Commission (EC) has no current regulation to approve extracts obtained with ILs to be applied in foods. Herein, this paper aims to assess the overview of ILs, regulamentation, applications, and its toxic effects, to be used as solvents for extract different bioactive compounds. Studies have suggested novel applications for ILs, such as 1-butyl-3-methylimidazolium bromide, 1-butyl-3-methylimidazolium chloride, 1-butyl-3-methylimidazolium tetrafluoroborate and others, to obtain bioactive compounds, for instance phenolic compounds, lignans, alkaloids, carotenoids, polysaccharides, using modern approaches as ultrasound and microwave-assisted extraction. New IL methods increase the efficiency of recovering target compounds and decrease the extraction time and VOS consumption regarding the traditional techniques. Furthermore, to promote the large-scale use of IL in foods, it is essential to investigate individually the toxicity of each IL used in the extraction processes, aiming to obtain a GRAS stamp, due to the currently lack of regulamentation. [ABSTRACT FROM AUTHOR]

Defining the European vector of development of Ukraine in the model of international cooperation as a priority involves the use of European standards in the field of law. This is impossible without careful adaptation work to bring the domestic legal system in line with the system that exists in the countries of the European Union. Recent changes in legislation have been long-awaited and have been a breakthrough in the corporate and financial sectors. The authors aim to carry out a comprehensive analysis of Ukrainian corporate law by comparing the political governance of Eastern Europe, economic and political aspects of the current situation, problems of corporate governance and ways to solve them, and the current stages of adaptation of corporate law in its transformation to the EU’s norms. In February 2018, the European Commission proposed to consider 2025 a possible date for the accession of Serbia and Montenegro, which means recognizing these countries as the first league in the Balkans, even in case the EU Council does not approve this date. The second league was set by the Council in June 2018, when 2019 was marked as a possible conditional date for the opening of accession negotiations with Albania and Macedonia. While the third league is for the accession of Bosnia and Kosovo, for which no date has been set. Negotiations with Turkey have been suspended. For comparison, if we take into account both political and economic indicators, Ukraine is approximately equal to the Balkan states of the second league. The prospect of EU membership has been recognized as the strongest external factor in domestic political change in the countries surrounding the EU. In accordance with the requirements of the Association Agreement with the EU on corporate law (EU Directives No. 2001/34/EC, No. 2003/71/EC, No. 2004/109/EC, No. 2007/14/EC, No. 2007/36/EC, No. 2012/30/ ЕС, No. 2013/34/ЕС, Recommendations of the European Commission No. 2005/162/ЕС and No. 2004/913/ЕС) the Law of Ukraine No. 2210-VIII, the Law of Ukraine “On Limited Liability and Additional Liability Companies” dated February 06, 2018 No. 2275-VIII, amendments to the Laws of Ukraine №514-VI, “On Securities and Stock Market”, “On Business Associations”, the Economic Code of Ukraine, the Civil Code of Ukraine, the Criminal Procedural Code of Ukraine and other laws were made and came into force on July 1, 2021 in the Law of Ukraine No. 738-IX. European integration transformation of Ukrainian legislation in the context of protection of shareholders’ rights was manifested through the implementation of Directive 2004/25/EC in the Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine Concerning the Simplification of Doing Business and Attracting Investments by Issuers of Securities” dated March 23, 2017 No. 1983-VIII and the Law of Ukraine No. 514-VI. Ukraine’s economy has not yet recovered from the negative effects of the global financial crisis of 2008, the political coup, the national crisis of 2015, the current crisis caused by the COVID-19 pandemic. This situation shows declining dynamics, and changes in Ukrainian legislation are offset, not showing real effect. The harmonization of Ukrainian legislation is complicated by the unwillingness of Ukraine’s business environment to comply with EU rules. Analyzing the activities of the JSC, the dynamics of the securities market, stock market and the transformation of Ukrainian legislation, the initiatives of certain branches of government, we can say that Ukraine is moving in the right direction but not fast enough and forms a country with a real market economy. Therefore, we can conclude that the adaptation of Ukrainian corporate law to EU legislation should be carried out not only in relation to existing EU directives but in accordance with general trends and prospects for the development of European corporate law.

Copyright of Der Hautarzt is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The paper analyses the developments in the EU state aid policy as a result of the COVID-19 pandemic breakout. The general framework for state aid in the EU was presented. Based on a case study analysis of selected airlines that benefited from state aid following the COVID-19 crisis, changes in the European Commission approach were identified. In general, investigation of arrangements between the state aid cases is a complex (and thus often lengthy) process. The outbreak of the COVID-19 pandemic was a challenge for EU member states and the European Commission as well due to the unexpected, turbulent, and very profound nature of the crisis. It made it necessary to look for new or revised policies for state aid to respond quickly and keep airlines afloat in times when the flow of revenue was practically stopped. One of the key issues that needed to be addressed was inflexibility and lengthiness of state aid approval processes. To this end, additional guidelines were introduced to make the state aid policy of the EU more flexible. This way member states could respond to the ongoing developments in a more targeted and objective-oriented approach, which possibly made state aid more efficient. It should be stressed that it could have been achieved without changes to pre-existing legislation and by adjusting executive guidelines instead. [ABSTRACT FROM AUTHOR]

The objective of this document is to make clear the importance of simplifying the transit of pleasure boats and their skippers safely in the European territory with the foreseeable improvement of the functioning of the internal market. In many European countries recreational skippers are required to have specific training and experience in order to demonstrate their maritime competence. These licenses for navigation allow a recreational vessel to be skippered in each national territory. One of the main objectives of these qualifications is to reduce the number of accidents in recreational boating. Generally speaking, in the European Union, as regards the requirements for the management of pleasure craft, both private and professional, the requirements are very different depending on the member state.

This article raises the issues related to the influence of increased availability of various categories of spare parts in the market on the cost of servicing passenger cars in Poland. The discussion is based on original simulations of the hypothetic cost of repairs involving several categories of spare parts. For the analysis, the authors selected models of vehicles that were demanded the most in Poland in recent years in the segment of brand new and second-hand cars. The purpose of this work is to show the differences in values arising in the case of using separate categories of spare parts in the class of repairs concerned. The presented research may be used to estimate the possible cost of use related to owning a specific model of a vehicle. Furthermore, the research results may be helpful in making purchase decisions by the individual as well as group clients.

This study sheds light on particular issues of poultry imports to the EU during the 1996–2014 period. First, we analyze the mechanisms of EU market protection through the evolution of tariffs and non-tariff measures (NTMs), both descriptively and econometrically. Second, we estimate bilateral ad valorem equivalents (AVEs) of different types of NTMs imposed on the imports of poultry to the EU. These AVEs hint towards the diverse impact of NTMs on various exporters based on their production compatibilities with EU standards. Third, we analyze the quality impact of NTMs, which are also differentiated by the exporting countries.

Poland was one of the first European countries to adopt a national regulatory framework for the operation of drones. During its first years (2013–2016), the national regulator was more focused on VLOS operations, and BVLOS operations were possible only in segregated airspace. Since 2019, a new law has allowed for certain types of BVLOS operations to be conducted outside of segregated airspace, at very low levels. This paper will analyze how national legislation is dealing with this new technology, focusing on the new law on BVLOS operations. As the national regulation will be replaced in June 2020 by common European rules that have been adopted 2019, this paper also aims to highlight the most important provisions of the EU regulation. [ABSTRACT FROM AUTHOR]

This study sheds light on particular issues of poultry imports to the EU during the 1996-2014 period. First, we analyze the mechanisms of EU market protection through the evolution of tariffs and non-tariff measures (NTMs), both descriptively and econometrically. Second, we estimate bilateral ad valorem equivalents (AVEs) of different types of NTMs imposed on the imports of poultry to the EU. These AVEs hint towards the diverse impact of NTMs on various exporters based on their production compatibilities with EU standards. Third, we analyze the quality impact of NTMs, which are also differentiated by the exporting countries. [ABSTRACT FROM AUTHOR]

Since May 2008 applying EU GDPR regulation became mandatory for all member States. The aim of the GDPR (General Data Protection Regulation) is to protect all EU citizens from privacy and data breaches in today's data-driven world. The (GDPR) is considered being the most important change in data privacy regulation in the last 20 years. As a consequence, all public institutions and private companies operating with personal data are obliged to fully comply with the requirements of the GDPR. As long as the data processing is automated and many information is collected in electronic format, the IT&C sector is deeply involved in assuring the fair level of personal data protection. The present paper aims to show some action to be taken by the management regarding the IT department within firms and institutions, in order to comply with GDPR regulation. [ABSTRACT FROM AUTHOR]

A complex set of European regulations aims to facilitate regenerative medicine, harmonizing good clinical and manufacturing standards and streamlining ethical approval procedures. The sociology of standardization has elaborated some of the effects of regulation but little is known about how such implementation works in practice across institutions and countries in regenerative medicine. The effects of transnational harmonization of clinical trial conduct are complex. A long-term ethnographic study alongside a multinational clinical trial finds a range of obstacles. Harmonization standardizes at one level, but implementing the standards brings to the fore new layers of difference between countries. Europe-wide harmonization of regulations currently disadvantages low-cost clinician-lead research in comparison to industry-sponsored clinical trials. Moreover, harmonized standards must be aligned with the cultural variations in everyday practice across European countries. Each clinical team must find its own way of bridging harmonized compulsory practice with how things are done where they are, respecting expectations from both patients and the local hospital ethics committee. Established ways of working must further be adapted to a range of institutional and cultural conventions that affect the clinical trial such as insurance practices and understandings of patient autonomy. An additional finding is that the specific practical roles of team members in the trial affect their evaluation of the importance of these challenges. Our findings lead to conclusions of wider significance for the sociology of standards concerning how regulation works and for medical sociology about how trial funding and research directions in stem cell medicine intersect. [ABSTRACT FROM AUTHOR]

In the last period became more and more evident the practice of some great units from food industry to make use at the so-called "double standard" for products which are delivered on own markets and respectively on other countries markets. For these reasons we aimed to study the quality conditions of powder milk destined for infants commercialized in Romania and their concordance with European Union regulations. Investigations were carried out on three powder milk formulas (under 6 month; 6-9 months; over 9 months) imported from Holland, Germany and Poland and consisted in evaluation of physical indicators (acidity, moisture content, solubility and starch presence) as well as for microbiological ones (TNG and Escherichia coli identification), using agreed methodologies. From the obtained data resulted the fact that powder milk imported from Holland had the lowest acidity (15.58-16.09oT), lower with 1.31-6.33% than the one from Germany and with 9.30-18.33% than the one from Poland, but also the lowest moisture content (3.18-3.20%), lower with 8.39-9.68% and respectively, with 19.87-22.5% than at other producers. The best solubility (99.65-99.68%) was also at milk produced in Holland, and the lowest one was obtained for milk imported from Poland (98.17-98.20%). Milk manufactured in Poland had a positive reaction for starch at two from the studied formulas and the one from Germany only at a single formula. Microbiologically speaking, only the formula destined for infants of over 9 months produced in Poland had surpassed the admissible limit for Escherichia coli. In conclusion, we could affirm that powder milk for infants commercialized in Romania fulfil the quality conditions stipulated by EU regulations. [ABSTRACT FROM AUTHOR]

This article raises the issues related to the influence of increased availability of various categories of spare parts in the market on the cost of servicing passenger cars in Poland. The discussion is based on original simulations of the hypothetic cost of repairs involving several categories of spare parts. For the analysis, the authors selected models of vehicles that were demanded the most in Poland in recent years in the segment of brand new and second-hand cars. The purpose of this work is to show the differences in values arising in the case of using separate categories of spare parts in the class of repairs concerned. The presented research may be used to estimate the possible cost of use related to owning a specific model of a vehicle. Furthermore, the research results may be helpful in making purchase decisions by the individual as well as group clients. [ABSTRACT FROM AUTHOR]

Term single window can mean the point of contact for communication in relation: ship – shore and shore – ship. In this sense, it is mentioned for example in the IMO Resolution A.950(23) “Maritime Assistance Service (MAS)” adopted on 5 December 2003. It can also mean a service or institution on land that collects all information related to safety of navigation before sending them on ships, as defined in the IMO documents on e-navigation. Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting formalities for ships arriving in and/or departing from ports of the Member States and repealing Directive 2002/6/EC requires that vessels shall transmit reports mentioned in the IMO conventions and codes and European Union (EU) and national legislations only once through the national single window established in each EU member state not later than on 1 June 2015. The question is whether these different functions of above-mentioned contact points can be implemented by one shore based institution or service. The article contains an analysis of these issues and tries to answer the set question.

The implementation of the CSM regulation by the European Commission in 2009 which harmonizes the risk assessment process and introduces a rather new concept of judging changes within the European railway industry. This circumstance has risen the question how other technology sectors handle the aspect of modifications and alterations. The paper discusses the approaches for judging the significance of modifications within the three transport sectors of European railways, aviation and maritime transportation and the procedure which is used in the area of nuclear safety. We will outline the similarities and differences between these four methods and discuss the underlying reasons. Finally, we will take into account the role of the European legislator and the fundamental idea of a harmonization of the different approaches.

The paper points to the main elements important for understanding the obligations arising from the process of accession of the Republic of Serbia (RS) to the European Union (EU) as related to water resources management. The general framework is determined by the importance of water resources for contemporary international relations as well as the rules governing the process of harmonizing the national legislation with the EU legislation. This paper provides an overview of the most important regulations of the RS and the EU in the field of water resources management, including its status in international treaties. Drawing upon the rules governing the harmonization process, the paper provides indicators of the achieved level of compliance of national legislation with key EU regulations in the field of water resources management. The provided analysis is based on the premise that the process of joining the EU is the main factor that determines the current position and policy of RS in the field of water resources management. In that context, management of water resources falls into the group of EU regulations which are, within the framework of Chapter 27, most difficult to transpose and apply in the internal legal system. Although the process of harmonizing the national legislation with the EU legislation has been underway as regards a vast number of regulations, the process of reaching full compliance is likely to take a couple of years. Concurrently, it has been estimated that the full implementation of legislation harmonized with the EU legislation will take at least two decades, primarily due to the substantial financial resources to be invested in the development of water infrastructure. In terms of participation in the activities undertaken within the framework of international agreements in the field of water resources management and the state's membership in relevant international treaties, it is noted that in the last decade the RS has managed to counterbalance the delay which was, for the most part, a consequence of the circumstances generated in the last decade of the 20th century. The RS is currently a state party to all the relevant international multilateral agreements in the field of water resources management, except for the New York Convention on the Law of the Non-navigational Uses of International Watercourses. However, regulation of bilateral relations with neighboring countries is still considered to be one of the issues that could be significantly improved.

Background: Although regulatory guidance defines which preclinical data are required in general before proceeding to first-inhuman clinical trials, a certain level of flexibility exists in the actual planning, timing, and design of a drug development program. Developing an ophthalmic medicinal product adds additional challenges, since the eye is a complex organ with unique features and specialized ophthalmic guidance documents are sparse. Methods: We analyzed the preclinical guidelines with a focus on European Union legislation and guidance documents provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We elaborated the particularities specific to ophthalmic drug developments and deduced the preclinical knowledge needed to safely enter a first-in-human trial program. Two hypothetical medicinal products for ophthalmic indications were chosen and specificities for ophthalmic preclinical tests were elaborated. Results and conclusion: We conclude that the preclinical program of ophthalmic medicines is flexible and differs, based on the intended use and the nature of the active substance. [ABSTRACT FROM AUTHOR]

Copyright of Przegląd Elektrotechniczny is the property of Przeglad Elektrotechniczny and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Security, environmental, technical, and economic factors form a basis for selection of routes for new high-pressure gas pipelines. Environmental protection and protection of inhabitants shall be factored in when designing a new gas pipeline route. In the European Union, the final gas pipeline route is determined based on the environmental impact assessment process (EIA). In general, when designing a gas pipeline route, it is necessary to consider especially the following factors: minimization of the gas pipeline length, minimization of interventions into the protected areas of national and European networks (for example, NATURA 2000), avoiding of urban areas of villages and cities, areas featuring high levels of groundwater, rocky and land sliding areas, protected deposit areas, mining and survey areas, protection zones of water sources, flood areas, and areas with possible presence of historical ammunition discoveries. A proposed route leading across the areas exposed to the risk of landslides and across mining areas shall be resolved already in the Intention that represents the first step within the EIA process, and it shall also be discussed with mining authorities and operators of protected deposit areas, mining areas, and survey areas. The final version of the gas pipeline defined in the Final EIA Opinion shall be implemented into the zoning and development plans of higher territorial units, cities, and villages. The Final EIA Opinion is binding for further legal approval proceedings concerning the pipeline project. [ABSTRACT FROM AUTHOR]

The objective of this paper is to present the regulation of insolvency of banks and other financial institutions in some West Balkans countries (Serbia, Montenegro and FYROM) candidates for the EU membership and its development under the influence of the EU regulations. This question has become particularly interesting since the onset of the world financial crisis of 2008. Banks and financial institutions from the EU countries are among major players in financial markets. The crisis has shown that the models that have previously existed were not sufficient and did not enable an adequate level of cooperation between member states, in order to minimize the spreading of negative effects of individual insolvencies and problems of individual financial institutions across the EU and all over the world. Therefore, changes were needed in the regulations, and indeed, certain changes have been made. This paper tries to see and evaluate the enlargement of the EU which is currently not on top of the EU political and economic agenda, the candidate countries are in the process of adjusting their legislation and practices in order to be better prepared for negotiating with the EU, but also in order to make their respective economic conditions and markets more harmonized with the EU countries, therefore making them more attractive to potential foreign investors. We shall attempt to give a brief analysis of how several West Balkans EU candidate countries have reacted to the described changes in the EU regulations regarding financial institutions and handling their financial difficulties. [ABSTRACT FROM AUTHOR]

In Europe sulfur dioxide (SO2) and sulfites in foods and beverages at concentrations of more than 10 mg kg–1 or 10 mg L–1 expressed as SO2 equivalents are subject to mandatory labelling. In fresh meats the addition of sulfites is not admitted because of their unlawful use to give the product a more attractive appearance. Aim of the study was to detect sulfites in meat product sampled in 19 commercial shops of Lazio Region. In n=12 samples, sulfites were present at different concentrations and no indication for them was reported on the label. Sulfites concentrations ranged from 13.3 to 1278.9 mg kg–1. The results of the present investigation underline the need for better controls by operators, not only under the food information but also in the consumers’ health perspective.

Copyright of Accounting & Finance / Oblìk ì Fìnansi is the property of Institute of Accounting & Finance and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This paper highlights the energy market from the dynamic perspective of countries that are on the emerging frontier and try to evolve towards an auto sustained resources based economy. The paper presents how the framework developed by the European Union developed from mid 20th century to today's multi-leveled mechansim for creating a competitive globalised economy. [ABSTRACT FROM AUTHOR]

The analyses carried out both at the centre (Brussels) and at the destination (member states) (ab)use of the principle that in public expenditure terms “spent money means well-spent money” and consider that absorption capacity equals economic performance (equated quite disputably with disparity reduction). The aggregate Keynesian perspective provides the main argument in favour of this interpretation: EU funds lead to GDP growth (economic growth). This vision overlooks the crucial importance of resource allocation micro-processes, private property and business activity. Therewith, the process of making European funds profitable and, consequently, the EU convergence feasible depends on the extent to which the absorption environment is structurally reformed. The “cohesion paradox,” which can be formulated like “least underdeveloped regions have relatively higher chances to attract European funds, while disparities compared to relatively less developed regions might even intensify”, can be broken only through multi-dimensional reform, immaterial to whether we speak about Romania, or Ireland, or Portugal, or Spain, or Greece.

In view of the European Union regulations 1107/2009 and 528/2012, which say that basic substances in plant protection and biocidal products marketed in the European Union (EU) should not have an inherent capacity to cause endocrine disruption, an initiative was started to define scientific criteria for the identification of endocrine disruptors (EDs). The objectives of the EU strategy on EDs are to protect human health and the environment, to assure the functioning of the market, and to provide clear and coherent criteria for the identification of EDs that could have broad application in the EU legislation. Policy issues were to be addressed by the Ad-hoc group of Commission Services, EU Agencies and Member States established in 2010, whereas the scientific issues were to be addressed by the Endocrine Disruptors Expert Advisory Group (ED EAG), established in 2011. The ED EAG adopted the 2002 World Health Organization (WHO) definition of endocrine disruptor and agreed that for its identification it is necessary to produce convincing evidence of a biologically plausible causal link between an adverse effect and endocrine disrupting mode of action. In 2014, the European Commission proposed four ED identification criteria options and three regulatory options, which are now being assessed for socio-economic, environmental, and health impact. Slovenia supports the establishing of identification criteria and favours option 4, according to which ED identification should be based on the WHO definition with the addition of potency as an element of hazard characterisation. As for regulatory options, Slovenia favours the risk-based rather than hazard-based regulation. [ABSTRACT FROM AUTHOR]

Cancer clinical trials and, in general, cancer clinical research by definition need a multi-modality approach. It is not enough to discover and register new drugs. To get cancer under control requires us to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures and new radiotherapy approaches as well as, most importantly, to integrate all available information. This includes biological material and, of increasing importance, large amounts of data using big data technologies. To personalise treatment, genetic data are more and more frequently used. Therefore, the general approach is holistic. Legislators, on the other hand, work in a silo mentality; the needs of clinical research are poorly understood, and legislation focuses on either health care or the commercialisation of a product, and not on clinical research. In the last 2 years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, although the silo mentality makes the overall framework inconsistent and potentially highly damaging to the EU's capacity to make rapid progress in the field of personalised medicine. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]