This figure shows the state of the assessed commercially exploited fish and shellfish stocks per European marine region, for which assessments were conducted in 2019-2022. Stocks for which adequate information is available to determine Good Environmental Status (GES) for fishing mortality (F) and/or reproductive capacity (spawning stock biomass (SSB)) are included (i.e. Z, total number of stocks; Y, total number of assessed stocks; and X, number of stocks for which adequate information is available to determine GES on the basis of these two criteria). A distinction is made between stocks: (1) in good status based on both fishing mortality and reproductive capacity; (2) in good status based on only one of the criteria - fishing mortality or reproductive capacity (either because one of the two criteria is not in good status or because there is only one available criteria, and it is in good status); and (3) not in good status based on both fishing mortality and reproductive capacity (may include cases where only one criteria is available and it is not in good status).
This figure shows trends in the status of assessed commercially exploited fish and shellfish stocks between 1947 and 2021, expressed in two metrics-fishing mortality (F) and reproductive capacity (i.e. spawning stock biomass (SSB))-relative to their policy thresholds for the Marine Strategy Framework Directive's 'good environmental status' (GES) (i.e. FMSY and MSY Btrigger, respectively).
561673 Marina Živaljević Half of the respondents report that they are informed about the work of the State Prosecutor’s Office, while in 2022 less than a quarter reported the same. 41 per cent of respondents believe that the State Prosecutor’s Office is accessible and open to the public, which represents an increase of 11% compared to the previous year. Approximately 41 per cent of respondents believe that the work of the State Prosecutor’s Office is transparent, and a bit less than a half of respondents are familiar with this jurisdiction, indicating the need for improved communication between the institution and citizens. These are some of the findings from an opinion poll Perception of the State Prosecutor's Office in Montenegro, commissioned by the OSCE Mission to Montenegro and conducted by DeFacto Consultancy in September 2023. “Overall, nearly one-third of the respondents hold a positive or somewhat positive general attitude towards the State Prosecutor’s Office, while just over one-third have a some-what negative or very negative attitude,” said Slaven Živković of the DeFacto, presenting the results. The survey also shows that trust in state prosecution offices at all levels has increased compared to 2022. Almost fifty per cent of citizens have some or complete trust in the Supreme State Prosecutor’s Office, a seven per cent increase from 2022, and around 55 per cent of respondents have some or complete trust in the Special State Prosecutor's Office, a 12 per cent increase from 2022. Corruption and organized crime were overwhelmingly identified as problems in Montenegro, showing that citizens have strong expectations in the work of the Prosecution in this regard. Tatjana Begović, Acting Supreme State Prosecutor, thanked the OSCE Mission to Montenegro for its continuous support of this annual research. “We are encouraged that this year’s research shows a growing trust in state prosecution offices at all levels. At the same time, this obligates us to further improve our work.” said Ms. Begović. Head of OSCE Mission to Montenegro, Dominique Waag welcomed the decision to publicize the research for the second time. “This will support the Supreme State Prosecutors’ Office in enhancing their communication with citizens. To boost transparency is imperative for the State Prosecution Service to communicate effectively with the public and the activities they undertake, said Waag, adding that to inform the public about ongoing OCC cases, in line with transparency standards, while ensuring the presumption of innocence, is of public interest.” The OSCE Mission to Montenegro assisted the Supreme State Prosecutor’s Office in drafting and implementing their first communication strategy; an important effort to increase transparency and institutional outreach. In addition to supporting this research, the Mission contributes to the production of a TV format “Get to know the Prosecutor’s Office”, to enhance the State Prosecution Office’s public outreach. The Mission will continue its support to State Prosecution Service in 2024 and offered to equip a conference/press room to communicate effectively with the media and the public. The public opinion survey on the perception of the State Prosecutor’s Office in Montenegro was conducted on a sample of 1,002 adult respondents, using a multistage random sampling selection method.
Genetically modified maize DP23211 was developed to confer control of certain coleopteran pests and tolerance to glufosinate‐containing herbicide. These properties were achieved by introducing the pmi, mo‐pat, ipd072Aa and DvSSJ1 expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP23211 and its conventional counterpart needs further assessment, except for those in levels of histidine, phenylalanine, magnesium, phosphorus and folic acid in grain, which do not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD072Aa, PAT and PMI proteins and the DvSSJ1 dsRNA and derived siRNAs newly expressed in maize DP23211, and finds no evidence that the genetic modification impacts the overall safety of maize DP23211. In the context of this application, the consumption of food and feed from maize DP23211 does not represent a nutritional concern in humans and animals. Therefore, no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP23211 grains into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP23211. The GMO Panel concludes that maize DP23211 is as safe as its conventional counterpart and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.
La plataforma Zeroport, de la qual forma part Ecologistes en Acció de Catalunya, considera que amb aquesta comissió bilateral, obstinada a cercar possibles ampliacions de l’aeroport, els governs de l’Estat i de la Generalitat demostren prioritzar l’agenda de la patronal en detriment de les polítiques socials i ambientals. La entrada Denuncien que la comissió sobre l’ampliació de l’aeroport del Prat només respon a les demandes dels grups d’interès empresarials i va en contra dels objectius climàtics/ecològics i dels interessos més bàsics de la societat aparece primero en Ecologistas en Acción.
Modalités : Présentiel et zoom pour les intervenants Entrée libre (dans la limite des places disponibles) Une pièce d'identité sera obligatoire pour rentrer dans l'établissement
The future of risk assessment cannot neglect to consider the vast literature produced through the application of new approach methodologies (NAMs). This, however, constitutes a challenge for the risk assessor, as the availability of data in this context is huge and heterogeneous both for the methods applied and the standardisation and quality of the results. The integration of results generated from NAMs is hence only feasible under some degree of automation of the risk assessment workflow, specifically for searching, extracting and integrating such results in “AOP‐like” knowledge networks (AOP – Adverse Outcome Pathway). Artificial intelligence (AI) with its state‐of‐the‐art methods and tools is one of the most promising sources to support automation of manual tasks among modern technologies. The present paper illustrates the results of the exploration of possible applications of AI to achieve this goal. After the introduction of an evaluation framework to quantitatively assess these tools and methods, the results of the implementation of six selected case studies with the support of a selection of such tools in a dedicated workflow are presented. A qualitative survey of the state‐of‐the‐art tools and methods, which also incorporates the experience gathered during the case study implementation, is then presented. Finally, recommendations are formulated which address the main aspects identified through the case study implementation that should, in the opinion of the authors, be pursued by EFSA in the context of its SPIDO NAMs and AI roadmaps. In summary, potentials for AI tool support could be identified throughout the workflow. Although many of the tasks can be supported by (semi‐)automation, experience showed that subject matter experts need to be involved in all workflow steps.
A systematic literature review (SR) registered in PROSPERO (CRD42023412241) and compliant with EFSA guidelines and the PRISMA statement on systematic reviews, was performed for the retrieval of relevant studies on adverse outcome pathways for the capacity of proteins to trigger celiac disease (CD). Search queries, together with grey literature search, resulted in the identification of relevant documents that were used to collect original data by means of data extraction, categorisation, risk of bias appraisal and data synthesis of high‐level information. A summary table was used to propose AOPs for CD. The investigation revealed that gluten, non‐gluten proteins, bacterial peptides, viral peptides, and a 55 kDa autoantigen played a role in various molecular initiating events (MIEs), with gluten proteins being the most common initiators. Furthermore, several shared characteristics were identified in the resulting AOPs across various MIEs, with structural mimicry emerging as a prominent recurring pattern, i.e., when foreign proteins or peptides have a similar structure to gluten. The studies emphasized the resemblance between the TFIIA protein and gliadin, the ability of gluten‐reactive T cells to react to bacterial peptides, and the identification of viral proteins by anti‐transglutaminase IgA antibodies in individuals with CD. These observations emphasize that CD is an intricate interaction between genetic and environmental factors, where structural mimicry connects these components and contributes to the autoimmune response in individuals with CD. This work aims to facilitate the path towards the development of a consolidated AOP pertinent to proteins triggering CD consistently to the principles defined by the OECD, in particular for the assessment of the risk of bias and for the data reporting.
Second European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 29 November 2023
Clinical Trials Information System (CTIS) sponsor end user training programme - February 2024, European Medicines Agency, Amsterdam, the Netherlands, from 12 February 2024, 09:00 (CET) to 15 February 2024, 13:30 (CET)
Genetically modified maize DP915635 was developed to confer tolerance to glufosinate herbicide and resistance to corn rootworm pests. These properties were achieved by introducing the ipd079Ea, mo‐pat and pmi expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP915635 and its conventional counterpart needs further assessment, except for the levels of crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD079Ea, PAT and PMI proteins expressed in maize DP915635. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize DP915635. In the context of this application, the consumption of food and feed from maize DP915635 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP915635 is as safe as the conventional counterpart and non‐GM maize varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP915635 grains into the environment, this would not raise environmental safety concerns. The post market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP915635. The GMO Panel concludes that maize DP915635 is as safe as its conventional counterpart and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.
Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 January 2024, European Medicines Agency, Amsterdam, the Netherlands, from 16 January 2024 to 18 January 2024
It is said âwe eat first with our eyesâ. The colour of food and drink can have a major influence over what we choose to consume, so which pigments are expected to whet appetites in 2024?
The Mediterranean region stands at a crossroads, grappling with the pressing challenges of environmental degradation, climate change, and economic inequality. In response to... The post EMGN Annual Conference 2023: “Assessing the Suitability of Traditional Guarantee Schemes to Drive the Growth of the Green Economy in the Mediterranean” – 17.01.2024 appeared first on EMEA.
The European Food Safety Authority (EFSA) strives to develop new methodologies (quantitative and qualitative) for assessing animal welfare of food‐producing animals by 2027 and start collecting standardised and good quality animal welfare (AW) data by 2030. In light of its vision, EFSA identified the need to develop an action Roadmap for the More Welfare project: towards new risk assessment methodologies and harmonised animal welfare data in the EU. This Roadmap maps existing animal welfare assessment methods, tools, and data collection activities for different species of food‐producing animals through literature review, desk research, online surveys, and workshops. It identifies data and knowledge gaps as well as challenges and blockers prevalent in AW assessment. In doing so, the roadmap points towards research areas that require further development (i.e., working areas), but also highlights collaboration opportunities and priority strategies (actions and project proposals) necessary for achieving EFSA's vision. Seven working areas for animal welfare assessment were identified and discussed with EFSA and external AW experts during virtual workshops, touching upon the definition of animal welfare, indicators and tools for welfare assessment, and the development of frameworks to assess and/or prioritise animal welfare issues. Finally, the Roadmap formulates five project proposals, each of them presenting high‐level recommendations on multi‐annual and multi‐partner projects that were identified in collaboration with EFSA and AW experts, each supported by a SWOT analysis.
Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations, European Medicines Agency, Amsterdam, the Netherlands, from 1 February 2024, 15:30 (CET) to 1 February 2024, 17:00 (CET)
La Comisión Europea ha publicado hoy su informe de síntesis de 2023 sobre la ejecución de los Fondos Estructurales y de Inversión Europeos (Fondos EIE), en el que se muestran algunos de los logros generales de los Fondos EIE a finales de 2022. Estos fondos son los principales instrumentos financieros de la política de cohesión, que apoyan las inversiones en desarrollo regional del período de programación 2014-2020.
Yemen: Statement by the High Representative on behalf of the EU welcoming the UN Security Council resolution strongly condemning Houthi attacks on Red Sea shipping.
Eleventh meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, European Medicines Agency, Amsterdam, the Netherlands, 24 November 2023
Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 14 February 2024, 10:00 (CET) to 14 February 2024, 13:30 (CET)
The qualified presumption of safety (QPS) process was developed to provide a safety assessment approach for microorganisms intended for use in food or feed chains. The QPS approach is based on an assessment of published data for each taxonomic unit (TU), with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a TU are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. In the period covered by this Statement, no new information was found that would change the status of previously recommended QPS TUs. Of 71 microorganisms notified to EFSA between April and September 2023 (30 as feed additives, 22 as food enzymes or additives, 7 as novel foods and 12 from plant protection products [PPP]), 61 were not evaluated because: 26 were filamentous fungi, 1 was Enterococcus faecium, 5 were Escherichia coli, 1 was a bacteriophage (all excluded from the QPS evaluation) and 28 were TUs that already have a QPS status. The other 10 notifications belonged to 9 TUs which were evaluated for a possible QPS status: Ensifer adhaerens and Heyndrickxia faecalis did not get the QPS recommendation due to the limited body of knowledge about their occurrence in the food and/or feed chains and Burkholderia ubonensis also due to its ability to generate biologically active compounds with antimicrobial activity; Klebsiella pneumoniae, Serratia marcescens and Pseudomonas putida due to safety concerns. K. pneumoniae is excluded from future QPS evaluations. Chlamydomonas reinhardtii is recommended for QPS status with the qualification ‘for production purposes only’; Clostridium tyrobutyricum is recommended for QPS status with the qualification ‘absence of genetic determinants for toxigenic activity’; Candida oleophila has been added as a synonym of Yarrowia lipolytica. The Panel clarifies the extension of the QPS status for genetically modified strains.
From 2024-06-03 to 2024-06-07, online and Nara, Japan, IUFRO Unit(s) involved: 7.02.11 WCPP is a series of biennial meetings that have the long tradition started in Malta in 1973, providing opportunities to exchange information and discuss new discoveries among experts of parasitic plants. WCPP2024 will cover a wide range of topics of parasitic plants research, including strigolactone biology, molecular mechanisms, genome evolution and management technologies. Scientific program will include cutting edge research and exciting reports for various aspects of plant parasitism on diverged plant species, presented as oral or poster formats. The program will also include social events visiting the ancient city of Nara and enjoying Japanese cuisine. We are looking forward to meeting researchers from all over the world and exciting discussion.
Commission Implementing Decision (EU) 2024/224 of 10 January 2024 on the harmonised standards for appliances burning gaseous fuels drafted in support of Regulation (EU) 2016/426 of the European Parliament and of the Council - OJ L, 2024/224, 12.01.2024
The applicant Detia Freyberg GmbH submitted to the competent national authority in Germany two requests to evaluate the confirmatory data that were identified for tree nuts, oilseeds, cereals and commodities of animal origin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available and two requests in accordance with Article 6 of Regulation (EC) No 396/2005 to increase the existing MRL for the active substance aluminium phosphide in peanuts, barley, oat, rye, rice and wheat, roots of herbal infusions, cocoa beans and seed spices and for the active substance magnesium phosphide in oilseeds (except peanuts) and pistachios. The four applications were combined by EFSA under the current assessment. To address the data gaps, validation data for the method of analysis for enforcement of phosphide in high‐oil content commodities and new residue trials were submitted. The data gaps on additional residue trials supporting authorisations on oilseeds and cereal grains, on clarifications regarding the discrepancies observed in the residue trial results for pistachios, and on data confirming the negligible occurrence of phosphane and its oxidation products in livestock products were considered addressed. The data gap on independent laboratory validation (ILV) and a confirmatory method for monitoring of phosphide in high‐oil content commodities was considered not fully addressed. The information provided justified a lowering of the current tentative MRLs for the whole group of cereals (except rice and ‘others’), an increase of the current tentative MRLs for pistachios, the whole group of oilseeds, rice and ‘other’ cereals, herbal infusions from roots, cocoa beans and seed spices, and a revision of the risk assessment performed for phosphane and its phosphide salts. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of AlP and Mg3P2 according to the reported agricultural practices is unlikely to present a risk to consumer health. Further risk management considerations are required.
Ecologistas en Acción de la Ribera ha analizado el pliego para contratar la redacción del plan de movilidad urbana sostenible de Tudela y concluye que es un documento totalmente deficiente. La entrada El pliego para contratar la redacción del plan de movilidad urbana sostenible de Tudela es totalmente deficiente y no se ajusta a la Ley Foral de Cambio Climático aparece primero en Ecologistas en Acción.
Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2876 of 18 December 2023 amending Decision 2013/255/CFSP concerning restrictive measures in view of the situation in Syria.
The food enzyme containing cellulase (EC 3.2.1.4), endo‐1,3(4)‐β‐glucanase (EC 3.2.1.6) and endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the non‐genetically modified Trichoderma reesei strain AR‐256 by AB‐Enzymes GmbH. A safety evaluation of this food enzyme was made previously,* in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in seven food manufacturing processes. Subsequently, the applicant requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine food manufacturing processes: processing of cereals and other grains for the production of 1) baked products, 2) cereal‐based products other than baked, 3) brewed products, 4) starch and gluten fractions, 5) distilled alcohol; processing of fruits and vegetables for the production of 6) wine and wine vinegar, 7) juices, 8) fruit and vegetable products other than juices and 9) fruit‐derived distilled alcoholic beverages other than from grape. As the food enzyme–total organic solids (TOS) is removed from or not carried into the final foods in three food manufacturing processes, the dietary exposure to the food enzyme–TOS was estimated only for the remaining six processes. It was up to 4.049 mg TOS/kg body weight (bw) per day in European populations. Using the no observed adverse effect level (NOAEL) reported in the previous opinion (939 mg TOS/kg bw per day), the Panel derived a revised margin of exposure of at least 232. Based on the revised exposure calculation and the outcome of the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
ESAs consult on draft implementing technical standards specifying certain tasks of collection bodies and certain functionalities of the European Single Access Point 08 January 2024 Market data The three European Supervisory Authorities (EBA, EIOPA and ESMA – the ESAs) today published a Consultation Paper on the draft implementing technical standards (ITSs) regarding the tasks of the collection bodies and the functionalities of the European Single Access Point (ESAP). These ITSs and the requirements they set out are designed to enable future users to be able to effectively harness the comprehensive financial and sustainability information centralised on the ESAP. Stakeholders are encouraged to provide their feedback to this consultation by 8 March 2024. The purpose of this consultation is to give interested parties the opportunity to provide their views on the proposed rules with regard to: Tasks of collection bodies: automated validations to be performed on the information submitted by entities, the characteristics of the Qualified Electronic Seal, the open standard licenses to be applied, the characteristics of the data collection application programming interface (API), the characteristics of the metadata for the information, the time limits for providing the information to ESAP, the indicative list of formats that are acceptable as data extractable and as machine readable. Functionalities of the ESAP: the characteristics of the data publication API, the legal entity identifier to be used to identify the entities that submit the information or to which the information relates, the classification of the types of information, the categories for the size of the entities, and the characterization of industry sectors to classify the information contained in ESAP and allow users to search for it. The establishment of the ESAP is a flagship action of the Capital Markets Union Action Plan. The purpose of the ESAP is to facilitate access to publicly available information of relevance to financial services, capital markets and sustainability. The ESAP is expected to become operational in July 2026 and will start publishing information no later than July 2027. Consultation process Comments on this consultation can be sent to the ESAs via the ESMA’s consultation page. The deadline for the submission for comments is 8 March 2024. All contributions received will be published following the end of the consultation, unless requested otherwise. Public hearing ESAs will organise a public hearing in the form of a webinar. More details will be provided in due course on the ESAs websites. Next steps The ESAs will consider the feedback received to this consultation and will submit the draft ITSs to the European Commission by 10 September 2024. Further information: Cristina Bonillo Senior Communications Officer@ press@esma.europa.eu 08/01/2024 JC 2023 78 Consultation Paper on draft ITS specifying certain tasks of collection bodies and certain functionalities of the European Single Access Point Consultation on draft ITS specifying certain tasks of collection bodies and certain functionalities of the European Single Access Point
Galego | Castellano Un mes después de que se produjera el vertido y dos semanas después de que se habían comenzado a detectar los plásticos en los arenales gallegos, no se adoptó ningún plan de acción por parte de la Xunta. La entrada Colectivos ecologistas y del mar denuncian la inacción de la Xunta con el vertido de pellets y anuncian acciones de voluntariado y una querella contra la naveira aparece primero en Ecologistas en Acción.
Un mes despois de que se producise a vertedura e dúas semanas logo de que se comezaran a detectar os plásticos nos areais galegos, non se adoptou ningún plan de acción por parte da Xunta. La entrada Colectivos ecoloxistas e do mar denuncian a inacción da Xunta co vertido de pellets e anuncian accións de voluntariado e unha querela contra a naveira aparece primero en Ecologistas en Acción.
Attachment: Populations japonaises (Japanese Populations) (IFRAE, CRCAO) Organizers: Chiharu Chūjō, Jeremy Corral Supported by: Association for Cultural Typhoon
Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2788 of 11 December 2023 amending Decision 2013/184/CFSP concerning restrictive measures in view of the situation in Myanmar/Burma.
The Russian missile killed 44-year-old Viktor Kobzystyi, Ukrainian basketball player, coach, and international master of sports of Ukraine. He played for the Ukrainian national team at the European Championships in 2001 and 2005 The post Russian morning attack killed 26, injured at least 132, damaged maternity and oncology hospitals, lyceums, kindergarten, mall, administrative buildings and numerous buildings (photos) appeared first on Euromaidan Press.
The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for difenoconazole are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Spain and presents EFSA's scientific views and conclusions on the individual comments received.
The figure shows the percentage point variations in the share of buses, trains, trams and metro (collective modes) and of inland waterways and trains (non-road modes) in total inland passenger and freight transport activities respectively by country.
Les 11 et 12 décembre derniers avait lieu le colloque « Chouchi, la Perle du Caucase » qui inaugurait formellement le programme de documentation et de préservation du patrimoine arménien.
PERSAM is a software tool for predicting environmental concentrations of plant protection products (PPPs) in soil commissioned by EFSA. The PERSAM tool was first launched in 2013. In support of the EFSA Guidance Document for predicting environmental concentrations of PPPs in soil (2017), the PERSAM software tool was updated for calculating the predicted environment concentration of PPPs in soil.The computerized tools will be released for use by applicants and risk assessors for the evaluation of PPPs and transformation products according to Parliament and Council Regulation (EC) 1107/2009.The software application assists the user in performing calculations using the analytical model, as described in the guidance document for predicting environmental concentrations of PPPs in soil (2017). More specifically, the software will be able to calculate:✓Tier‐1 Predicted Environmental concentrations✓Tier‐2 95th‐percentile PECs✓Selection of the grid cell including the scenario properties corresponding to the 95th‐percentile PEC as needed for the scenario development at Tier 3A and generation of a so‐called transfer file that can be read by the numerical models described in the Guidance Document.PERSAM generates reports intended for regulatory submissions. Based on these reports the authorities need to be able to check or reproduce the model results.This report describes the issues addressed and the solutions implemented in PERSAM 3.0.2 to 3.0.8.
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 3 June 2024 to 7 June 2024
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 13 May 2024 to 17 May 2024
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 15 April 2024 to 19 April 2024
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 4 March 2024 to 8 March 2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 November 2023, 10:00 (CET) to 23 November 2023, 12:00 (CET)
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 29 January 2024 to 2 February 2024
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the mixture of Sepiolite and Kieselguhr (diatomaceous earth) (Anpro) as a technological feed additive for all terrestrial animal species. According to the conventional risk assessment, due to lack of adequate data, the safety of the additive Anpro for the target species cannot be established. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and therefore no concern for the consumer. The additive poses a risk by inhalation. It is not irritant to the skin or eyes but should be considered as skin sensitiser. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles could not be assessed for the target species, the consumer and the user. The additive is safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of the additive for all terrestrial animal species.
Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2764 of 7 December 2023 amending the list of persons, groups and entities subject to Common Position 2001/931/CFSP on the application of specific measures to combat terrorism.
La organización ecologista, integrante del Consejo de Participación de Doñana, considera que este órgano que comparte con el equipo de gestión de la Junta la toma de decisiones en el espacio protegido, no está siendo informado reglamentariamente sobre los asuntos y proyectos que pueden afectar a Doñana. La entrada Ecologistas en Acción reclama a la Junta de Andalucía transparencia activa y respeto para el Consejo de Participación de Doñana en la gestión del espacio protegido aparece primero en Ecologistas en Acción.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) NCIMB 30139 as a technological additive for use in easy to ensile fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. The additive is not skin irritant, but no conclusions can be drawn on the skin sensitisation or eye irritation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of natrolite–phonolite obtained from volcanic rock from Kaiserstuhl as a technological additive (functional group: anticaking) for all animal species. According to the conventional risk assessment, due to the lack of adequate data, the Panel is not in a position to conclude on the safety of the additive for the target species under the proposed conditions of use. However, from the tolerance studies in cattle for fattening and weaned piglets, effects observed in animal performance and blood clinical biochemistry suggest adverse effects on the animals supplemented with the additive. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and, therefore, of concern for the consumer. The FEEDAP Panel is not in the position to conclude on the potential of the additive to be a skin and eye irritant. The additive is considered a respiratory and dermal sensitiser. In the absence of suitable data, the presence of small/nanoparticles cannot be excluded. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles for the target species, the consumer and the user could not be assessed. Due to the lack of sufficient data, the Panel is not in a position to conclude on the efficacy of the additive.
Commission Communication in the framework of the implementation of Regulation (EC) No 1907/ 2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Publication of titles and references of European standards under entry 27 (nickel) of Annex XVII to REACH)
Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2792 of 11 December 2023 amending Decision (CFSP) 2023/1532 concerning restrictive measures in view of Iran’s military support to Russia’s war of aggression against Ukraine.
The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for the aqueous extract from the germinated seeds of sweet Lupinus albus are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State the Netherlands and presents EFSA's scientific views and conclusions on the individual comments received.
The first progress report on the climate and environmental objectives of the 8th Environment Action Programme (8EAP) published by the European Environment Agency today highlights what needs to be done to achieve the EU's 2030 climate and environmental targets. The report underlines the need to conclude negotiations on the Green Deal proposals the Commission put […]
On 6 December 2023, more than 60 people attended the Final Event of the COSME-funded project S4Fashion, titled “Next4Fashion: Unlocking New Sustainable Pathways”.
The European Food Safety Authority (EFSA) commissioned RPA Europe and FoBiG to carry out the study ‘Mapping of data requirements and assessment methodologies linked to the regulatory frameworks and remits of the relevant EU Agencies (ECHA, EFSA and EMA) and EC Scientific Committees (Scientific Committee on Consumer Safety, SCCS, and Scientific Committee on Health, Environmental and Emerging Risks, SCHEER)’ (service contract OC/EFSA/FIP/2022/01 managed by the EFSA Unit on Food Ingredients and Packaging). The general objective was to collect and analyse data requirements (DRs) and risk assessment methodologies (RAMs) applied within the regulatory frameworks of EFSA, the European Chemicals Agency (ECHA), the European Medicines Agency (EMA), SCCS and SCHEER. For comparative analysis, a digital data inventory containing 230 records on legal acts, guidance and other documents related to DRs and RAMs was developed. Based on a comparative analysis methodology, the database of DRs and RAMs across different regulatory frameworks was created by extracting information on DRs (with respect to substance identity, physico‐chemical and environmental fate properties as well as ecotoxicity and toxicity and target organism safety) and RAMs (for the environment, human health and target organisms) from relevant documents. The study identified inconsistencies within regulatory areas in some cases, e.g. between legal acts and guidance documents. Furthermore, it found differences between regulatory frameworks in the DRs and RAMs with respect to terminology, general and detailed DRs and RAMs, the quality standards for experimental studies and other issues. Based on the identified differences and the potential for harmonisation across the regulatory frameworks, several recommendations were outlined in the study that involve addressing specific as well as more principal and structural differences.
Le 17 novembre dernier, à l’occasion de la Journée Mondiale de la Prématurité au Palais du Luxembourg, le RES a organisé en partenariat avec les sociétés médicales de pédiatres (AFPA et AFPEL), d’endocrinologues (SFE) et de néonatologues (SFN) et ESPT, le colloque: «De la Prématurité aux Maladies Infantiles : l’enjeu des Perturbateurs Endocriniens». L’objectif de ce The post La mortalité néonatale augmente depuis 10 ans en France et la France a reculé de la 3ème à la 20ème position en Europe. Pourquoi ? Un constat alarmant au cœur du colloque du 17 novembre first appeared on Réseau Environnement Santé. L’article La mortalité néonatale augmente depuis 10 ans en France et la France a reculé de la 3ème à la 20ème position en Europe. Pourquoi ? Un constat alarmant au cœur du colloque du 17 novembre est apparu en premier sur Réseau Environnement Santé.
Le 17 novembre dernier, à l’occasion de la Journée Mondiale de la Prématurité au Palais du Luxembourg, le RES a organisé en partenariat avec les sociétés médicales de pédiatres (AFPA et AFPEL), d’endocrinologues (SFE) et de néonatologues (SFN) et ESPT, le colloque: «De la Prématurité aux Maladies Infantiles : l’enjeu des Perturbateurs Endocriniens». L’objectif de ce L’article La mortalité néonatale augmente depuis 10 ans en France et la France a reculé de la 3ème à la 20ème position en Europe. Pourquoi ? Un constat alarmant au cœur du colloque du 17 novembre est apparu en premier sur Réseau Environnement Santé.
Le 17 novembre dernier, à l’occasion de la Journée Mondiale de la Prématurité au Palais du Luxembourg, le RES a organisé en partenariat avec les sociétés médicales de pédiatres (AFPA et AFPEL), d’endocrinologues (SFE) et de néonatologues (SFN) et ESPT, le colloque: «De la Prématurité aux Maladies Infantiles : l’enjeu des Perturbateurs Endocriniens». L’objectif de ce L’article La mortalité néonatale augmente depuis 10 ans en France et la France a reculé de la 3ème à la 20ème position en Europe. Pourquoi ? Un constat alarmant au cœur du colloque du 17 novembre est apparu en premier sur Réseau Environnement Santé.
Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies, European Medicines Agency, Amsterdam, the Netherlands, 26 November 2018
The European Commission has approved a €140 million Portuguese scheme to support the production of renewable hydrogen and biomethane to foster the transition to a net-zero economy, in line with the Green Deal Industrial Plan. The scheme was approved under the State aid Temporary Crisis and Transition Framework, adopted by the Commission on 9 March […]
As part of the comprehensive twelfth package of sanctions adopted earlier today, the Council decided to impose restrictive measures on an additional 61 individuals and 86 entities responsible for actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine. Today’s new listings target primarily the military and defence sectors. The Council is listing […]
The Council imposed restrictive measures on an additional 61 individuals and 86 entities in respect of Russia’s continued war of aggression against Ukraine.
Last September, the National Renewable Energy Center (CENER) launched a new project aimed at developing and showcasing the potential of Synthetic Biology in key areas for the economic development of Navarra. Synthetic biology combines principles from biology, chemistry, engineering, and… The post SYNTHBIOMICS kicks off, a project to drive Health, Food, Sustainable Energy, and Industrial Decarbonization through Disruptive Synthetic Biology Innovations. appeared first on CENER - National Renewable Energy Centre.
ACT EU Clinical Trials Analytics Workshop - January 2024, European Medicines Agency, Amsterdam, the Netherlands, from 25 January 2024, 13:00 (CET) to 26 January 2024, 13:00 (CET)
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance zoxamide. To assess the occurrence of zoxamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission and the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the Applicant Gowan Crop Protection Ltd, submitted a request to the competent national authority in Latvia to set an import tolerance for zoxamide in onions (extrapolated to garlic and shallots) based on the use authorised in USA. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under assessment. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of zoxamide according to the agricultural practices on onions, garlic and shallots is unlikely to present a risk to consumer health.
EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 April 2024 to 17 April 2024
Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2721 of 4 December 2023 amending Decision (CFSP) 2020/1999 concerning restrictive measures against serious human rights violations and abuses.
Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2721 of 4 December 2023 amending Decision (CFSP) 2020/1999 concerning restrictive measures against serious human rights.
Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2686 amending certain Council Decisions concerning restrictive measures in order to insert provisions on humanitarian exceptions.
Declaration by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2540 of 13 November 2023 amending Decision (CFSP) 2016/849 concerning restrictive measures against the Democratic People’s Republic of Korea.
Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2023/2423 of 26 October 2023 amending Decision 2010/573/CFSP concerning restrictive measures against the leadership of the Transnistrian region of the Republic of Moldova.
NOTICIA: La oficina CDTI-SOST Bruselas promueve una nueva edición de su Programa presencial de Especialización de Gestores en programas europeos de I+I (PEG)
ACT EU PA08 multi-stakeholder methodology workshop, European Medicines Agency, Amsterdam, the Netherlands, from 23 November 2023, 09:00 (CET) to 23 November 2023, 17:00 (CET)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of zinc chloride hydroxide monohydrate as a nutritional feed additive for all animal species (3b609). The applicant reported changes in the production process and requested a change in the specification of the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) confirms that the use of the additive under the current authorised conditions of use is safe for the target species and the consumers. The use of the additive in animal nutrition at the proposed use levels for the terrestrial species and land‐based aquaculture systems is considered safe for the environment. The FEEDAP Panel cannot conclude on the safety of the additive for marine sediment compartment, when it is used in sea cages. The additive is an eye irritant, but not irritant to the skin and not a skin sensitiser. The exposure through inhalation is likely, but in the absence of data, the Panel is not in a position to conclude on the risk of exposure by inhalation. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
560523 Donors to the OSCE Secretariat Extra-Budgetary Support Programme for Ukraine Within primary financial support from the European Union, the OSCE Secretariat Extra-Budgetary Support Programme for Ukraine (SPU) organised a roundtable “Priority Setting in Mine Action and Draft National Strategy” in Kyiv on 14 December 2023. At the event 60 representatives of Ukrainian mine action agencies and international organizations, central and local authorities, demining operators were able to discuss ways to introduce improved planning and co-ordination of all actors in this sphere with due regard to best international practices and local realities. Miljenko Vahtaric, the SPU’s Mine Action Technical Advisor, shared Croatia’s experience in assigning demining priority status to specific categories of lands, depending on its use by local communities. Olena Kryvova, an expert from Geneva International Center for Humanitarian Demining, highlighted the importance of establishing priorities in mine action in international practice. Prioritization in mine risk education and in organization of assistance to victims was also in focus. Representatives of Ministry of Defense spoke about the current process of forming annual demining plans, while the State Emergency Service of Ukraine presented practice of organizing the work of its mine action teams. The Ministry of Economy of Ukraine used the occasion to table for review by participants the provisions of the draft of national mine action strategy, gather input and observations from local and international demining operators, as well as representatives of local authorities from the regions, heavily affected by Russia’s war of aggression , such as Donetsk, Luhansk, Kharkiv, Chernihiv, Kherson, Kyiv, Sumy, Mykolaiv and Zaporizhzhya oblasts. Marcel Peško, Special Representative of the OSCE Chairmanship – Project Coordinator in Ukraine noted that “solving the problem of explosive remnants of war will be the key challenge in the process of post-war reconstruction, and it already severely endangers lives of Ukrainians in many communities. Co-ordinated response of all mine action agencies is key to swift and effective resolution of the problem, that is why we are supporting efforts to streamline planning and management of operations in this sphere, notably development of national strategy”. Arturo Rodriguez Tonelli, Regional Programme Manager EU Service for Foreign Policy Instruments (FPI), Delegation of the European Union to Ukraine, commented: “A clear and coherent set of priority criteria across all aspects of mine action is essential to ensure that communities receive assistance tailored to their most urgent needs. The European Union makes mine action a priority in its humanitarian and recovery support to Ukraine. Coordinating efforts will ensure that resources are put to best use and help international partners better target their humanitarian mine action support to Ukraine”. For reference: This effort is part of “Support to Environmental Rehabilitation with Focus on Building National Humanitarian Mine Action Capacities of Ukraine” Project implemented with primary funding provided by the European Union, as well as contributions from the Organization's participating States; see full list of the Programme's donors.
Agreement between EU negotiators on electricity market design reform positive for PPA market but Member State implementation and RES deployment are crucial next steps 15th December 2023, Brussels RE-Source Platform welcomes this week’s agreement between EU negotiators on the revision of the EU’s electricity market design (EMD). Energy buyers and suppliers have been enthused by … Agreement between EU negotiators on electricity market design reform positive for PPA market but Member State implementation and RES deployment are crucial next steps Read More » The post Agreement between EU negotiators on electricity market design reform positive for PPA market but Member State implementation and RES deployment are crucial next steps appeared first on RE-Source Platform.
At the end of the COP28 UN Climate Conference in Dubai, European Union negotiators succeeded, with partners from around the world, to keep alive the possibility of delivering on the commitment in the Paris Agreement to limit global average temperature increase to 1.5 Celsius above pre-industrial levels. With a particular focus on the energy sector […]
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a new preparation of zinc‐l‐selenomethionine, with selenium content of 4%, as a nutritional feed additive for all animal species. Zinc‐l‐selenomethionine is already authorised for use in all animal species (3b818). Current authorisation defines the additive as ‘Solid preparation of zinc‐l‐selenomethionine with a selenium content of 1–2 g/kg’. The applicant developed a new preparation of zinc‐l‐selenomethionine containing a minimum of 40 g Se/kg and seeks to modify the current authorisation. The FEEDAP Panel concluded that the newly proposed preparation is considered safe for all animal species. The FEEDAP Panel recommends adding, to the currently existing authorisation, a new preparation (40–46 g Se/kg) and not the range proposed by the applicant (1–46 g Se/kg), since no characterisation data on the intermediate preparation range (from 2 to 40 g Se/kg) have been provided. The use of the new preparation (minimum 40 g Se/kg) of zinc‐l‐selenomethionine in animal nutrition is of no concern for consumer safety. The newly proposed preparation presents a risk by inhalation; it is not irritant to eyes or skin. No conclusion can be reached regarding dermal sensitisation. The previous conclusion by the Panel on the safety for the environment remains unchanged. The Panel concluded that the modification request has no impact on efficacy.
This is the 12th time that the European Union has imposed restrictions on Russian businesses. According to Castellum.ai, a global sanctions monitoring database, Russia has faced 11,327 restrictions since February 22, 2022. The total number of sanctions imposed on the country and its citizens has exceeded 14,000 - writes Gary Cartwright in EU Today However, despite this, big Russian […]
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the feed additive containing Enterococcus faecium DSM 21913, Bifidobacterium animalis ssp. animalis DSM 16284 and Ligilactobacillus salivarius (formerly Lactobacillus salivarius) DSM 16351 (Biomin® C3) as a zootechnical feed additive (functional group: gut flora stabiliser) in the context of the renewal of the authorisation for chickens for fattening, chickens reared for laying and minor poultry species other than laying. In addition, the applicant requested the extension of use in all poultry species for fattening and reared for laying/breeding. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that the additive is safe for the target species, consumers and the environment under the authorised conditions of use. This conclusion also applies to the target species for which a request for an extension of use is made. The Panel concluded that Biomin® C3 is not irritant to skin or eyes but should be considered as a respiratory sensitiser due to its proteinaceous nature. No conclusions could be drawn on the skin sensitisation potential of the additive. The evaluation of the efficacy is not needed in those species for which an authorisation exists. The Panel considered that the additive is efficacious in all growing poultry species at the same inclusion level of 1 × 108 CFU/kg feed and the equivalent level in water of 5 × 107 CFU/L.
Left graph: A decline in pH corresponds to an increase in the acidity of ocean water. Data originate from the Aloha station pH time series (adapted from Dore, J.E., et al., 2009, 'Physical and biogeochemical modulation of ocean acidification in the central North Pacific', Proceedings of the National Academy of Sciences of the United States of America 106:12235-12240). Changes here are similar to those that are observed over a shorter time frame in Europe (see here: http://www.climatechange2013.org/images/figures/WGI_AR5_Fig3-18.jpg). In figure, "In situ measurement (Aloha station)" corresponds to data based on in-situ measurements, while "Calculated (Aloha station)" corresponds to calculated data. Global annual average of surface ocean pH from the Copernicus Marine Service, based on a reconstruction method using in situ data and remote sensing data, as well as empirical relationships. Indicator is available at annual resolution, and from the year 1985 onwards. The error on each yearly value varies, and is added to the data file sheet. The estimated yearly uncertainty envelope shown in the figure is defined as the annual mean of pH ± 2 standard deviations, which corresponds to a 95% confidence interval of the mean estimate. Right graph: Time series (1870-2022) of decadal average observed sea surface temperature anomalies (°C), with respect to the period 1991-2020, for each of the European basins, for the European seas as a whole, and for the global ocean. Data sources: HadSST4.0.1.0 (1850-2022), ERSSTTv5 (1880-2022), HadISST1 (1870-2022) and satellite-based ESA CCI/C3S SST Climate Data Record v2.1 (1991-2022).
Organitzacions que treballen en tots els territoris de l’Estat contra la contaminació dels envasos de begudes s’uneixen en un manifest conjunt per exigir al nou Executiu de Sánchez i Ribera el desplegament per complet la Llei de Residus i el Reial Decret d’Envasos perquè el retorn de llaunes, ampolles i brics en botigues i supermercats […] L'entrada 68 entitats de tot l’Estat demanen al nou Govern la posada en marxa com més aviat millor del Sistema de Dipòsit per a envasos de begudes reutilitzables i d’un sol ús a Espanya ha aparegut primer a Rezero.
● ‘Flash poll’ by the European Council on Foreign Relations (ECFR) reveals Europeans are open-minded to Ukraine’s accession, despite economic and security risks from such a move. There is also considerable support for Moldova and Montenegro joining the EU. ● There is widespread opposition, however, to Turkey joining the EU, and cool responses to the […]
The post Press Release: COP28 sent strong signals for the energy transition but much work lies ahead to set it on course for a fossil-free and renewables-based economies by 2050 appeared first on REN21.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zeolites (≥ 50%) obtained from Neapolitan Yellow Tufa as a technological additive (functional group: anticaking) for all animal species. The additive is specified to contain not less than 50% of zeolites, namely phillipsite, chabazite and analcime. Neapolitan Yellow Tufa originates from the volcanic activity of Campi Flegrei, Italy. According to the conventional risk assessment, due to a lack of adequate data, the safety of the additive for the target species cannot be established. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and, therefore, of concern for the consumer. The additive poses a risk by inhalation. It is not irritant to the skin. The Panel cannot conclude on the eye irritancy and on the dermal and respiratory sensitisation potential of the additive. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles for the target species, the consumer and the user could not be assessed. The additive is safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species at 20,000 mg/kg complete feed.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Levilactobacillus brevis (formerly Lactobacillus brevis) DSM 23231 as a technological feed additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that evidence has been provided that the additive currently on the market complies with the existing terms of authorisation. The Panel also concluded that L. brevis DSM 23231 remains safe for all animal species, consumers and the environment under the authorised conditions of use. The additive should be considered a respiratory sensitiser. Based on the studies submitted regarding user safety, the preparation of the additive tested was shown not to be a skin or eye irritant. The Panel was not in the position to conclude on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of copper(II)‐betaine as a nutritional additive for all animal species and on the safety for the marine sediment when the additive is used in sea cages. The FEEDAP Panel concluded that the risk to the marine sediment is acceptable when the additive is used in sea cages. The additional statistical analysis of the results of the efficacy study already assessed in the previous opinion did not allow the Panel to conclude on the efficacy of the additive.
Council and Parliament strike provisional deal to continue the EU's participation in the research and innovation partnership in the Mediterranean area until the end of Horizon Europe.
560379 On 11 December, the Office of the Co-ordinator of OSCE Economic and Environmental Activities (OCEEA) organized a side event “Catalyzing change: Political will in fighting corruption” on the sidelines of the tenth session of the Conference of State Parties to the United Nations Convention against Corruption (UNCAC) in Atlanta, Georgia. During the event, OCEEA presented the OSCE’s work in promoting good economic governance and anti-corruption measures to ensure security and stability in the OSCE region. Furthermore, it underscored the essential role of political will in the fight against corruption, emphasizing its critical importance in shaping successful anti-corruption initiatives. “Political will is not merely important; it is instrumental in shaping the bedrock of robust anti-corruption measures and ensuring their effective implementation. In the broader context of advancing the rule of law and good governance, we recognize these not as abstract concepts but as fundamental prerequisites for prosperity and economic growth,” stressed Adea Pirdeni, Deputy Minister of Justice of Albania, in her opening remarks. "The OSCE is able to work actively and successfully with participating States to turn their anti-corruption commitments into tangible projects and actions via the work of OCEEA and other units,” said Professor Anita Ramasastry, Special Representative of the OSCE Chairperson-in-Office on Combatting Corruption. The OSCE’s role in supporting the establishment of Armenia’s Anti-Corruption Committee was also highlighted by Sasun Khachatryan, Chairman of the Committee: “It is an axiomatic truth that corruption damages all layers of public relations without exception, but now I would like to address its impact on the country’s economic development. The fact that the consistent and uncompromising fight against corruption is yielding its results is also evidenced by the economic indicators recorded by the Republic of Armenia.” During the week, OSCE also intervened during the General Discussion at the plenary, highlighting the Organization’s commitment to fulfill the mandate in the area of good governance and anti-corruption, and its support to its participating States in implementing their commitments under the UN Convention Against Corruption (UNCAC). The Conference of the States Parties (COSP) is the main policymaking body of the United Nations Convention against Corruption. It supports States parties and signatories in their implementation of the Convention, and gives policy guidance to UNODC to develop and implement anti-corruption activities. OSCE has the status of observer within this body.
On Monday 11th December 2023, the Euro-Mediterranean Economists’ Association held the final Advocacy Session focusing on Building an Enabling Environment for Entrepreneurs in the... The post EMEA holds final advocacy session providing policy recommendations to for economic prosperity and sustainability in the Southern Mediterranean for INVESTMED project appeared first on EMEA.
EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions?, European Medicines Agency, Amsterdam, the Netherlands, 29 February 2024
DARWIN EU Advisory Board meeting - 24 May 2023, European Medicines Agency, Amsterdam, the Netherlands, from 24 May 2023, 14:30 (CEST) to 24 May 2023, 16:30 (CEST)
Clinical Trials Information System (CTIS): Walk-in clinic - November 2023, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 November 2023, 16:00 (CET) to 15 November 2023, 17:00 (CET)
Clinical Trials Information System (CTIS): Walk-in clinic - January 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 January 2024, 16:00 (CET) to 24 January 2024, 17:00 (CET)
DARWIN EU Advisory Board meeting: 6 February 2023, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 February 2023, 10:00 (CET) to 6 February 2023, 12:00 (CET)
Clinical Trials Information System (CTIS): Walk-in clinic - March 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 March 2024, 16:00 (CET) to 12 March 2024, 17:00 (CET)
Webinar on the Union Product Database Data Quality Framework, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 January 2024, 15:00 (CET) to 11 January 2024, 16:30 (CET)
Committee for Medicinal Products for Human Use (CHMP): 11-14 December 2023, European Medicines Agency, Amsterdam, the Netherlands, from 11 December 2023 to 14 December 2023