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There is currently a broad consensus that children deserve access to medicines that have been specifically developed and researched for use in young patients. However, until recently, the development and testing of pediatric drugs was far from satisfactory. Although awareness of the lack of satisfactory treatment for children in the EU began to rise in the 1990s, the pharmaceutical industry showed insufficient interest in investing in the development of pediatric medicines. Economic considerations have also been a contributing factor to why companies have refrained from investing proactively in this sector. The fact that children grow and mature means that they are not a uniform subgroup. Therefore, in 2007, the EU introduced a regulation to stimulate the development of medicines for children. In this context, this article aims to examine the regulation of pediatric medicines in the European Union, the impact of this legislation, and the need for future changes to the legislative framework in order to achieve the key objectives of the pharmaceutical strategy for Europe. [ABSTRACT FROM AUTHOR]

This article provides an overview of the High-Level Conference on Ending Financial Discrimination Against Cancer Survivors held on the 15th of February 2024, in Brussels, Belgium. Organised under the auspices of the Belgian Presidency of the European Council and led by the European Initiative on Ending Discrimination Against Cancer Survivors, the focus was the "right to be forgotten" (RTBF), which seeks to prevent financial discrimination against former cancer patients by ensuring their medical history is not considered by insurers and lenders 5 years after the end of treatment and without recurrence of the disease. Through detailed discussions and poignant testimonies, the conference shed light on the profound impact of financial discrimination on cancer survivors' lives and the moral and legal imperatives to address it. The article concludes with recommendations for advancing RTBF legislation at both national and European levels, emphasising the importance of political will, medical research, and strong advocacy from the cancer community., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

This review analyses the current regulatory procedures for plant biostimulants, both at an EU level and beyond the EU, and explores the future regulation of these substances in the EU. Plant biostimulants are defined as products that stimulate plant nutritional processes regardless of the product's nutrient content, with the sole aim of improving one or more of the following characteristics of the plant and the plant rhizosphere or phyllosphere: the efficiency of nutrient use, tolerance to abiotic stresses, crop quality traits, availability of confined nutrients in the soil and rhizosphere, humification and degradation of organic compounds in the soil. This definition is reported in the proposals for new rules to regulate making CE-marked fertiliser products available on the market. This regulation, which includes a plant biostimulants category, will repeal the existing Fertilisers Regulation (EC) No. 2003/2003. This category of compounds is also used in non-European countries. Currently, as there are different market conditions and different national regulation requirements for plant biostimulants in different countries, the non-harmonised regulatory processes can lead to unfair competition between operators. The assessment of plant biostimulants should be harmonised as far as possible, to avoid fragmentation and ensure a level, reliable playing field. It is essential that a common market is created for these substances. [ABSTRACT FROM AUTHOR]

In this review, we depict the state of the art concerning the water quality management of bio-mineral bathing pools, and compare these to traditional swimming pools. Bio-mineral pools use a combination of mechanic filtration, bio-filtration, and UV-treatment to disinfect the water. Studies in test tanks have shown that bio-filtration is effective in maintaining the water quality with regard to the treatment of organic pollution. Concerning biological risks, the bio-mineral pool relies on UV-treatment to degrade bacteria. Unlike chemical disinfectant treatments, UV disinfection does not lose its effectiveness in the event of high traffic in the pool. However, as only the water taken up by the filtration system is disinfected, it is essential that all the water in the pool is filtered. If the pool has a dead zone, its water is not disinfected and there is a risk of localized pathogen development. As the development of bio-mineral pools spreads in Europe, legislation gradually follows. The health parameters measured differ slightly from one country to another, but there are constants: the measurement of Escherichia coli, Enterococci, and Pseudomonas aeruginosa. In terms of biological swimming pools, regulatory homogeneity across Europe does not exist. From these comparisons, Austrian legislation segmenting water quality into 4 categories ranging from "excellent" to "poor" represents legislation that combines health and safety with indications of possible malfunctions. Next, a study of three real sites of bio-mineral pools is presented. It appears that whatever the type of pool, bio-mineral filtration makes it possible to achieve performances comparable to those encountered in chlorinated swimming pools concerning the risks associated with fecal contamination and external pollution. On the other hand, when frequentation is high, as is the case in small pools used for aquafitness, monitoring the risks of inter-bather contamination, as illustrated by the presence of Staphylococcus aureus, reveals a recurring problem. Knowing that this parameter is not evaluated in bathing waters in the natural environment and that numerous studies show that Staphyloccocus aureus are always detected, even on beaches, we propose the definition of three thresholds: i.e., 0 CFU/100 mL (threshold value in Wallonia) for water of excellent quality, less than 20 CFU/100 mL (threshold value in France) for water of very good quality, less than 50 CFU/100 mL (contribution of bathers by simple immersion) for good quality water, and more than 50 CFU/100 mL for poor quality water. This document could therefore be converted into a manual for operators on the use and management of bio-mineral baths., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Due to the social and legislative implications, the presence of Anisakis spp. larvae in fishery products has become a concern for both the consumers and the official Control Authorities. The issuance of a large number of provisions, aimed at better managing fish products intended to be consumed raw or almost raw and the associated risks, resulted in a very complicate legal framework. In this work, we analyzed the evolution of the normative through an overview on the local and international legislations, focusing on issues that are of practical interest for Food Business Operators (FBOs) in the fishery chain. In addition, we performed a survey across the Department of Prevention of the Italian Local Health Authorities (LHA) and the main fish markets in Italy to collect the operating procedures and the monitoring plans. Overall, we found many differences, due to the absence of a national reference standard for the management of the Anisakis risk. From this examination, it turns clear that only a participation of all the involved institutions, a strategy of synergistic interventions, as well as a correct training of FBOs, can result in an effective risk management and a proper risk communication, which should overcome states of confusion and unnecessary negative impacts on the economy. [ABSTRACT FROM AUTHOR]

Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this article. This article analyses firstly the short term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonized medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g., the way in which hospitals are organized in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper will finally analyse also how health monitoring projects may change the traditional (non-) relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require to new legal rules. [ABSTRACT FROM AUTHOR]

After learning about the potential risks associated with various specific nanomaterials, concerns have been raised about adequacy of existing regulation in Europe and what should be done to address any potential regulatory gaps related to nanomaterials. Understanding the limitations of the current regulation in regard to nanomaterials is a starting point in a democratic and transparent process towards adapting existing laws and facilitating an informed discussion about which kind of regulatory options best address the identified limitations. In the following we will introduce key pieces of European legislation affecting nanomaterials, analyze their limitations, and provide a number of recommendations on how these can be overcome. We find that, although nanomaterials are in principle covered by the scope of many of the existing legislative frameworks, it is often unclear, if current regulations are actually applicable when it comes to specific nanomaterials and their diverse applications. Main limitations seem to be: that requirements to do safety evaluations are triggered by production volumes by tonnage not tailored to the nanoscale, the profound lack of (eco)toxicological data, and that thresholds values and occupational exposure limits cannot be established with existing methodologies. [ABSTRACT FROM AUTHOR]

The article presents a study that examines the correlation between trafficking of children and child labour in Europe. It explores issues that pertaining to child trafficking as the cause of the worst forms of child labour as well as a worst violations of children's rights. The study reveals that sexual exploitation and forced child labor are the primary causes of the worst forms of child labour of the region.

Abstract: Historically, due to the often overwhelming complexity of the substances migrating from food contact materials (FCMs) into food, the specific legislation in Europe started from the substances used to manufacture these materials and articles. There are, however, FCMs with migrates almost exclusively consisting of reaction products, such as those produced from resins used, e.g. for coatings (epoxy resins, polyesters, organosols, trimellitic acid resins). Since the reaction products do not necessarily have the same toxicological profile as the starting substances to produce the resins, the use of authorized starting substances does not rule out the migration of compounds endangering human health. The European framework Regulation 1935/2004 requires the safety of all substances migrating from FCMs into food. Resolution AP2004/1 on coatings of the Council of Europe puts the emphasis on the safety evaluation of the migrants rather than that of the substances used for manufacturing the resins and then the coatings. Nonetheless, the Code of Practice for Coatings recently issued by industry focuses on the evaluation of the starting substances to produce resins. The authors of this paper consider the present situation unsatisfactory. It is the duty of industry to respect the legal requirements and of the regulatory authorities to ensure that these requirements are met. The authors recommend setting a time limit to have this achieved. [Copyright &y& Elsevier]

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Abstract: Parts 1 and 2 of this work outlined the background and the general terms of assuring compliance of food contact materials (FCM) with European legislation by good manufacturing practice (GMP) and compliance declaration (CD). All stages of the manufacturing process are engaged in GMP defined as the process to achieve compliance of the final product with Article 3 of the Framework Regulation 1935/2004 and the specific legislation derived there from. For each relevant aspect, either compliance is concluded (explicitly stating compliance if this is required) or compliance work is delegated to later stages of manufacturing by corresponding instructions in the documentation accompanying the product. A compliance box (CB) is proposed to structure the process and the documentation. Here it is applied to metal closures for glass jars, which are internally coated and contain a gasket of plasticized PVC. A specific composition is assumed and possible compliance work discussed to illustrate how the system is conceived. The system is tested by the problems and issues concerning these lids during the last 10 years: indeed, most of them would have been avoided. [Copyright &y& Elsevier]

Abstract: EU legislation requires that compliance of food contact materials (FCMs) with Article 3 of the Framework regulation 1935/2004 be established by good manufacturing practice (GMP): compliance must be dealt with at all stages of the manufacturing supply chain, either concluding compliance regarding a given aspect or delegating specified work to later stages. If there is specific legislation in place, compliance declarations (CDs) are required at all stages of production. This paper proposes the compliance box (CB) to structure the compliance work and format the documentation: section (1) identifies the business operator, (2) specifies the product and its intended uses, (3) deals with the compliance of the substances used, (4) with specific migration limits (SMLs) and other substance-related restrictions, (5) with the overall migration limit (OML), (6) with the impurities, reaction products and other not intentionally added substances (NIAS), and (7) closes with the issue date and signature. At each production stage, the compliance work is documented in the format of a CB which remains in-house (supporting documentation, here called food contact documentation FCDoc). A CB with sections 3–6 being reduced to delegated compliance work and, if required, CDs accompanies the product (food contact declaration, FCDec). During the manufacturing process, CBs merge to the point where compliance work is concluded. For the implementation, guidelines are needed, e.g., on unclear conventions applied in the past, a threshold of control, the range of the manufacturing process encompassed, the types of justifications considered acceptable for stating compliance, and the estimation of exposure. The main difficulties are in the unintentionally added substances. [Copyright &y& Elsevier]

Abstract: EU legislation requires that compliance of food contact materials with the legal requirements must be assured at each stage of the supply chain. The process has to respect good manufacturing practice (GMP), and for this purpose GMP is defined as the tool to ensure compliance. Communication through the production chain is an essential part, clarifying which work has been done and what is delegated to subsequent business stages. At early production stages it is often not possible to conclude on compliance of the final material or article. For instance, migration can only be measured from the final material and compliance of a non-regulated substance may be uncertain at an early stage. In fact, assuming responsibility either means concluding compliance with justification in the supporting documentation or specifying the work to be done at later stages in the documentation accompanying the product. This paper interprets existing legislation and indicates difficulties regarding the needs of food business operators and the role of the enforcement authorities. [Copyright &y& Elsevier]

The purpose of this editorial is to examine whether the social dimension of the single European market (SEM) has stalled or come to an end. Design/methodology/approach - This editorial outlines the existing minimum standards in SEM, the processes whereby they have/are established, and reviews the progress on the revision of the working time and European Works Council (EWC) Directive, Findings - The absence of proposals from the EU Commission other than on temporary and agency workers since 2002 has the EU wide trade union bodies, especially the ETUC to argue that EU member states' government continue to have a higher priority for the economic Europe (for example, labour market flexibility) than the social Europe (the establishment of workers' rights). This view has been enforced in that the EU Commission has been tardy in its revision of the working time and the EWC Directives. In the summer of 2008, the commission brought forward a series of measures aimed at stressing the social dimension of the SEM. These included a revised EWC Directive but they are unlikely to continue trade unions in Europe that EU member state government give as much priority to the social Europe as well as the economic Europe. Originality/value - The editorial offers insights into the priority given to the social Europe relative to the economic Europe. [ABSTRACT FROM AUTHOR]

The European Water Framework Directive (2000/60/EC) is potentially ground-breaking legislation. It seeks to bring about improvement of aquatic habitats in Europe to ‘good ecological status’, defined as slightly different from ‘high ecological status’, with no or minimal human impact. The characteristics of pristine ecological status include nutrient parsimony, a defined characteristic structure of the system (including geomorphological structure and hydrology, biological and food web structure) and the connectivity and extent of the system that are essential for resilience to change. This modern ecological understanding is being ignored by government agencies charged with enacting the Directive. Schemes are being devised that measure secondary characteristics of habitats using approaches drawn from traditional water quality management. Typologies, indicated by the Directive to give a geographical basis within which to determine ecological status, are also being corrupted with different typologies used for different determinands. The ecological reality of reasonably distinctive, integrated systems (an erosive upland river versus a floodplain system, for example) is being avoided. Emphasis is being placed on precision of measurement of specific determinands rather than accuracy in what is being measured and proposed schemes are complex and expensive when accurate assessment could be carried out much more cheaply. Many are also likely to become redundant as effects of climate change take hold. The current approach will lead to some improvement in water quality but not to the fundamental change in ecological quality intended by the Directive and has partly been encouraged by lack of definition and contradictions within the Directive itself. Documented details currently available from the UK agencies are used to illustrate how the intentions of the Directive are being undermined for ostensibly political convenience through processes of redefinition and limitation of characteristics measured. There appears to be a parallel concern among official and non-governmental European bodies. [Copyright &y& Elsevier]

Purpose — The purpose of this paper is to discuss the prospects of integrated planning and management of the environment in the context of the Water Framework Directive (WFD) and river basin planning. Design/methodology/approach — The paper analyses the legal framework of the WFD and other related water and environmental legislation as well as the provisions for integrative practice in the WFD. Moreover it analyses the potential for integration with issues that are not provided for in the WFD, such as land use. The procedural elements of the WFD and other EU legislation are analysed for identifying common elements within a modern consensus and efficiency based planning mode. Findings — Three aspects of the integrated management framework for water and other environmental resources are highlighted. The first concerns the need for interaction between spatial land use planning and the integrated river basin management plans of the WFD, in order to ensure that land-use plans do not contradict water goals and that water planning also takes into account broader landscape related aspects. This demands the establishment of platforms for institutional interplay. The second is the need to integrate water goals into sectoral policies. This may be ensured by activating the impact assessment procedures for projects, plans and programmes which may have an impact on water resources and quality. The third concerns elements and procedures which are common to several pieces of legislations (e.g. management plans, monitoring, public participation), and which could benefit from the establishment of common databases, spatial information systems, and methods of communication. Originality/value — The paper aims to identify key issues related to integration of the WFD with other environmental EU legislation, the associated challenges posed to water management and other environmental management institutions and procedures, and the information systems and methods which may facilitate the integration. [ABSTRACT FROM AUTHOR]

Many VOC represent hazards to human health through chronic exposure. Recent European and world-wide legislation proposes limit values for ambient concentrations of these compounds. However, very little experimental data exists for true population exposure. In 1996, the European MACBETH initiative set out to measure population exposure to benzene in six European cities. This study details the French contribution to this program. Six campaigns were carried out, each comprising measurements at 100 outdoor sites and the participation of 50 non-smoking volunteers who wore personal samplers and had passive monitors installed in their homes. Iso-concentration maps were drawn for each campaign and the results showed that outdoor concentrations were significantly lower than indoors. Almost 75% of the volunteers were exposed to mean concentrations higher than the limit value of 5µgm3. It is demonstrated that personal exposure levels cannot be deduced simply by combining indoor and outdoor background concentrations. It is also shown that there is need for better knowledge of the contributions to overall exposure of outdoor microenvironments and the authors hope that future European directives will take this into account. [ABSTRACT FROM AUTHOR]

The Convention on Human Rights and Biomedicine, the first legally binding international instrument in the field of bioethics, was adopted in November 1996. In the present paper, following a brief overview of some of the Convention's provisions likely to conflict with national enactments already in effect, we shall attempt, on the basis of the materials available in the International Digest of Health Legislation, to analyse the positions adopted by the different states involved and to identify foreseeable conflicts, focusing on the following four issues: human genome; protection of the embryo; scientific research; and protection of live organ donors. [ABSTRACT FROM AUTHOR]

European Union legislation reflects the consensus reached by the governments of member states. Yet laws have to be implemented in widely differing national contexts and may not therefore achieve the same objectives or have the same effects. Proposals for regulating working conditions, promoting equality of opportunity and reconciling paid and unpaid work are often driven by the need to avoid competitive disadvantage, with little regard for their possible impact on the everyday lives of individuals. This paper examines the temporal dimension of European legislation from a gendered perspective, and its implications for the patterning of women's employment and family life. [ABSTRACT FROM AUTHOR]

Since the European Union is a law-intensive organization, growth of EU activity can best be assessed by the growth of regulation rather than by growth in expenditure or personnel. Moreover, the character of EU decision-making means that traditional explanations of policy growth have to be substantially adapted before they can be applied to the EU. An empirical analysis of all legislation ever issued by the EU and its predecessors tests a number of hypotheses relating to EU growth. While there is limited evidence for supporting the view that Commissioners can have an important impact on the scale and pace of legislation, the evidence suggests a trend towards an increasing preponderance of state-building legislation -- legislation which applies general principles to specific functional policy areas. [ABSTRACT FROM AUTHOR]

The management of sewage sludge originated from municipal wastewater treatment plants (WWTPs) is an urgent issue. In 2019, the local authority of the Piemonte region started a survey with the aim of collecting recent data concerning wastewater and sludge management in the WWTPs located in its own territory. The survey's results revealed that 60% of the sludge (51,000 t, as dry substance, d.s.) produced by the local WWTPs was recovered or disposed of outside of the region, and a similar amount of sludge was recovered in agriculture directly or after composting. The increase in the costs to accommodate sewage sludge in recovery or disposal plants, followed to a recent Italian Sentence (27958/2017), and the more and more stringent requirements fixed by lots of European countries for the application of sludge in agriculture, are pushing the Piemonte region authority to re-organize its own network for sludge management, with solutions based onto proximity and diversification. Whether the provisions of the current German legislation are applied in the future also in Italy, approx. 90% of sewage sludge produced into the Piemonte region should be incinerated, with a subsequent step of phosphorous recovery. The new regional plan, according to the Regional Address Deed, should consider a diversification of sludge treatment and recovery practices. On this basis, a need for new plants for around 40,000 t d.s./y could be planned.

Introduction: The specialty of OMFS in the UK is a dual degree specialty which was recognised in Europe within Annex V of Directive 2005/36/EU. Currently UK law matches that of the EU. Brexit may change this. DIRECTIVE 2005/36/EU: Defines two specialties within European nations, Dental, Oro-Maxillo-Facial Training DOMFS (Basic dental & medical training) and Maxillofacial Surgery (basic medical training). The UK sat within DOMFS and so specialists from DOMFS nations could travel and work in the UK. Specialists from all other nations were required to use the Certificate of Eligibility for Specialist Registration (CESR) route. DIRECTIVE 2013/55/EU: This directive updated 2005/36/EU regarding Mutually Recognised Professional Qualifications (MRPQ) including creating an international alert system for doctors in difficult Entry onto the UK OMFS Specialist List by CESR Route CESR application is a large and complex portfolio of evidence to demonstrate knowledge, skills and experience are equivalent to a Certificate of Completion of Training (CCT) holder. To date, no EU applicants have successfully completed a CESR application., Union of European Medical Specialists (uems): Even after Brexit, the UK will remain a full member of UEMS. The OMFS Section of UEMS is a source of information and support for specialists wishing to work in other nations and for nations wishing to develop an OMFS specialty in their nation., Access to Uk Omfs Training for Non-Uk Trainees: Applicants meeting the person specifications for approved OMFS specialty training (ST) posts in the UK are welcome to apply to the national selection process for OMFS specialty training in the UK. Many have done so successfully. Fixed term appointments and Fellowships are advertised and represent a useful route to gain support for application for training or through the CESR Route., Conclusions: The UK remains part of the diverse OMFS community in Europe. There is support from within the UK and from UEMS for trainees and specialists interested in coming to the UK to train or to work., (Copyright © 2020 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.)

Aerial parts containing cannabidiol can be purchased in a legal way but cannabis used as recreational drug is illegal in most European countries. Δ9-tetrahydrocannabinol is one of the main cannabinoids responsible for the psychotropic effect. European Union countries and Switzerland authorize a concentration of THC of 0.2 % and 1.0 % w/w, respectively, for smoking products and industrial hemp. Public health inspectors and law enforcement officers need to check the legality of samples. Therefore there is a need for innovative approaches, allowing quality control of these products in an easy way and preferably on site. In many countries, cultivation of industrial hemp is permitted if the THC content does not exceed 0.2 % w/w. A portable equipment could be a useful measuring tool for farmers to check for the THC content at regular time. In this work, 189 samples were analysed with a benchtop and a handheld NIR device in order to create two classification methods according to European and Swiss laws. All samples were also analysed by GC-FID to determine their THC concentration. Supervised analysis was applied in order to establish the best model. For the first classification, the accuracy was 91% for the test set with the benchtop data and 93 % for the test set with the handheld data. For the second classification, the accuracies were respectively 91 % and 95 %. The obtained models, hyphenating spectroscopic techniques and chemometrics, enable to discriminate legal and illegal cannabis samples according to European and Swiss laws., (© 2020 John Wiley & Sons, Ltd.)

Purpose - To introduce the Market in Financial Instruments Directive (MiFID) Design/methodology/approach - Provides a brief overview of the MiFID, how it widens the scope of business permitted under the "passport" regime, the types of financial institutions it covers, and the time frame for implementation Findings - The biggest challenge facing regulated firms is the limited time they will have to comply with MiFID's requirements. Originality/value - Discusses the scope and importance of MiFID. [ABSTRACT FROM AUTHOR]