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.
The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union “nutrivigilance” system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.
Despite the increasingly strict legislation on medicinal products, the „off-label use“ or „use of medicinal product outside the approved summary of product characteristics (SmPC)“ is a weak point of today’s drug regulation and raises many questions about the risk, ethics, and legality of this type of practice. In recent years, through guidance and legal changes in some countries were defined the conditions and responsibilities, but in the most European countries still lack rules for off-label prescribing. The purpose of this study was to identify and analyse different approaches to regulation, adopted by some member states as well as to summarize the efforts in demand of common harmonized approach to solve this problem within the European Union. In the study, we used the available regulatory information in different electronic resources associated with the off-label drug use in selected European countries without limited time range. The results show that decisions taken to regulate the issue have significant differences and specific approach, while none of them is enough satisfactory and comprehensive. In conclusion, it can be claimed that the existing regulatory rules in various countries require significant improvement and update.
Inmaculada Sierra, Carolina Hernández, Paula Albendea and Maria Antonia López
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Angel M. Dzhambov, Karamfil M. Bahchevanov, Kostadin A. Chompalov and Penka A. Atanassova
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. Research on genetic disorders such as LPLD and ADA-SCID aim to develop treatments for these kinds of genetic diseases that have high rates of morbidity and mortality. Alipogene tiparvovec (brand name Glybera), is a gene therapy product indicated for the treatment of LPLD, which was approved for use in the EuropeanUnion on March 8, 2004 [ 1 ], and to date has only successfully treated one patient. After Glybera, Strimvelis was the second gene therapy approved by European Medicines Agency (EMEA) for the treatment of ADA-SCID [ 2 ]. It was the first instance of marketing
DS Minchev, NT Popov, SI Naimov, IN Minkov and TI Vachev
Professor I. Ivanov (Department of Pediatrics and Medical Genetics, Medical University of Plovdiv, Plovdiv, Bulgaria) for their technical insights and support of this study.
Declaration of Interest . The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.
Funding . This project received funding from the EuropeanUnion's Horizon 2020 research and innovation program under grant agreement No. 739582 (Project PlantaSYST).
1 Leonard LB. Children with specific language
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Ivica Prlić, Ana Mostečak, Marija Surić Mihić, Želimir Veinović and Luka Pavelić
The ERICA project (Environmental Risk from Ionising Contaminants: Assessment and Management) was co-funded by the European Union as part of the 6th Framework Programme (FP EURATOM). The project was carried out between 2004 and 2007 as the collective work of 15 organisations in seven European countries. Two significant outputs of the project are the ERICA Integrated Approach and the ERICA Tool. The ERICA Integrated Approach consists of three elements: assessment, risk characterisation and management. The ERICA Tool is a practical implementation of the assessment component of the ERICA Integrated Approach and has a three-tier structure. The aim of this review paper is to give a concise overview of ERICA project outputs and their structure, updates done since their first release in 2007, as well as to provide a context for their practical application in environmental radiation protection and radiological risk assessments for various engineering scenarios.