Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS, Online, from 13 February 2024, 10:00 (CET) to 13 February 2024, 11:30 (CET)
The food enzyme protein–glutamine γ‐glutamyltransferase (protein–glutamine: amine γ‐glutamyltransferase; EC 2.3.2.13) is produced with the non‐genetically modified Streptomyces mobaraensis strain M2020197 by Taixing Dongsheng Bio‐Tech Co. Ltd. The identity of the production strain and the absence of viable cells could not be established. The food enzyme is intended to be used in eight food manufacturing processes: processing of cereals and other grains for the production of (1) baked products, (2) cereal‐based products other than baked; processing of dairy products for the production of (3) fermented dairy products, (4) cheese, (5) dairy desserts; processing of plant‐ and fungal‐derived products for the production of (6) meat analogues, (7) plant‐based analogues of milk and milk products; processing of meat and fish products for the production of (8) modified meat and fish products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 3.498 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 91 mg TOS/kg bw per day. The calculated margin of exposure for each age group was 36 (infants), 26 (toddlers), 50 (children), 99 (adolescents), 115 (adults) and 133 (the elderly). A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is low. The safety of the food enzyme could not be established given the derived margins of exposure. Therefore, the Panel concluded that the food enzyme could not be considered safe under the intended conditions of use.
This reporting manual provides guidance to European Union Member States for reporting on zoonoses and zoonotic agents in animals, food and feed under Directive 2003/99/EC, Regulation (EU) 2017/625, Commission Implementing Regulation (EU) 2019/627 and Commission Delegated Regulation (EU) 2018/772 and also on reporting other pathogenic microbiological agents or contaminants in food. The objective of this manual is to harmonise and streamline reporting by Member States to ensure that the data collected are relevant and comparable for analysis at the EU level. This manual covers all the zoonoses and zoonotic agents included under the current data collection system run by the European Food Safety Authority. Detailed instructions are provided for reporting data in tables and information in free‐text forms. They cover the description of the sampling and monitoring schemes applied by the Member States, as well as the monitoring results. Special reference is made to data elements which enable trends to be identified and the analysis of sources of zoonotic agents at the EU level. This manual is specifically aimed at guiding the reporting of information derived from the year 2023.
A notification from WhatIF F&I Pte Ltd (Singapore) has been submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market dried seeds and flour thereof of Vigna subterranea (L.) Verdc. as a traditional food from a third country (TF). In line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union (EU). The TF consists of dried seeds and flour thereof of Vigna subterranea (L.) Verdc. (bambara groundnut) that have been consumed for more than 25 years in Africa. The TF is proposed to be marketed in the EU as dried seeds and flour thereof. EFSA considers that the available data on composition and history of use of the TF do not raise safety concerns. Considering the available data, EFSA does not raise safety objections to the placing on the market of the TF (dried seeds and flour thereof of Vigna subterranea (L.) Verdc.) within the EU.
Background: COVID-19-related global health governance (GHG) processes and public health measures taken influenced population health priorities worldwide. We investigated the intersection between COVID-19-related GHG and how it redefined population health priorities in Canada and other G20 countries. We analysed a Canada-related multilevel qualitative study and a scoping review of selected G20 countries. Findings show the importance of linking equity considerations to funding and accountability when responding to COVID-19. Nationalism and limited coordination among governance actors contributed to fragmented COVID-19 public health responses. COVID-19-related consequences were not systematically negative, but when they were, they affected more population groups living and working in conditions of vulnerability and marginalisation.Policy options and recommendations: Six policy options are proposed addressing upstream determinants of health, such as providing sufficient funding for equitable and accountable global and public health outcomes and implementing gender-focused policies to reduce COVID-19 response-related inequities and negative consequences downstream. Specific programmatic (e.g., assessing the needs of the community early) and research recommendations are also suggested to redress identified gaps.Conclusion: Despite the consequences of the COVID-19 pandemic, programmatic and research opportunities along with concrete policy options must be mobilised and implemented without further delay. We collectively share the duty to act upon global health justice.
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - January 2024, European Medicines Agency, Amsterdam, the Netherlands, 29 January 2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), European Medicines Agency, Amsterdam, the Netherlands, 29 January 2024
Committee for Advanced Therapies (CAT): 6-8 December 2023, European Medicines Agency, Amsterdam, the Netherlands, from 6 December 2023 to 8 December 2023
Committee for Herbal Medicinal Products (HMPC): 29-31 January 2024, European Medicines Agency, Amsterdam, the Netherlands, from 29 January 2024 to 31 January 2024
On 24 January 2024, the Secretary General of Europa Nostra participated in the conference “Protecting Armenian Cultural and Religious Heritage in Nagorno-Karabakh”, hosted by Miriam Lexmann… The post Europa Nostra participates in the conference “Protecting Armenian Cultural and Religious Heritage in Nagorno-Karabakh” hosted by the European Parliament appeared first on Europa Nostra.
Ante la solicitud a la Confederación Hidrográfica del Tajo por parte de ASAJA instando a la limpieza de arroyos y ríos de la comarca de Talavera para prevenir inundaciones, Ecologistas en Acción Toledo ha remitido un escrito recordando a la administración que nuestros arroyos necesitan ser restaurados, no “limpiados”. La entrada Ecologistas en Acción Toledo reivindica el valor y funcionalidad de la vegetación de ribera como elemento regulador de las avenidas de agua en cauces y riberas aparece primero en Ecologistas en Acción.
Debe acreditarse el interés público de esta Modificación del PGOU, presentar otras alternativas de ordenación, valorar los efectos ambientales sobre los recursos y el paisaje agrario afectados, considerar los efectos acumulativos y sinérgicos de la abusiva clasificación de suelo industrial en un ámbito saturado, garantizar su compatibilidad con otros planes territoriales concurrentes como, por ejemplo, las DOTVAENT, y contemplar medidas significativas para tratar los posibles efectos ambientales negativos en los corredores verdes y el suelo agrícola La entrada Piden que en la Modificación del PGOU para instalar la factoría de Inobat se proteja el resto de la vega agrícola entre la Vereda de Palomares y el Canal del Duero y se respeten la Vereda, la Cañada Real y el Canal aparece primero en Ecologistas en Acción.
The different sea regions are presented in the Y axis. The X axis corresponds to the number of time series with statistically significant decreasing trends (green), increasing trends (orange) and no trends (grey). Statistical significance at p
Ecologistas en Acción presenta alegaciones al Plan Regional Integrado de Energía y Clima 2023-2030 (PRIEC), donde exige un incremento en la reducción de las emisiones, mayores objetivos de reducción del consumo energético y una planificación más detallada. La entrada El Plan Regional Integrado de Energía y Clima 2023-2030 aún está lejos de una transformación rápida, justa y definitiva frente a la emergencia climática aparece primero en Ecologistas en Acción.
ACT EU Training for non-commercial sponsors: Transitioning trials to the CTR (CTIS) , Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 February 2024, 10:00 (CET) to 9 February 2024, 13:00 (CET)
Commission Implementing Decision (EU) 2024/373 of 24 January 2024 on the harmonised standards for inspection of pesticide application equipment in use drafted in support of Directive 2009/128/EC of the European Parliament and of the Council - OJ L, 2024/373, 25.01.2024
EMA Veterinary Medicines Info Day 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 March 2024, 14:00 (CET) to 15 March 2024, 12:30 (CET)
3Sun, Enel Green Power's photovoltaic cell and modules production gigafactory, has secured a 560 million euro financial package to back the expansion of its production capacity, in a significant milestone for Europe’s energy transition and security. The financing was made possible through a collaborative effort between the European Investment Bank (EIB), supported by InvestEU, and a pool of Italian banks, led by UniCredit and comprising BPER Banca (Corporate & Investment Banking) and Banco BPM, backed by SACE.
Commission Implementing Decision (EU) 2024/354 of 19 January 2024 on harmonised standards for cableway installations drafted in support of Regulation (EU) 2016/424 of the European Parliament and the Council - OJ L, 2024/354, 23.01.2024
Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 22 January 2024, 10:00 (CET) to 22 January 2024, 13:30 (CET)
Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reporting, Online, from 1 March 2024, 09:30 (CET) to 1 March 2024, 15:40 (CET)
EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma, Online, European Medicines Agency, Amsterdam, the Netherlands, 12 January 2024
The EIB and the Nordic Investment Bank (NIB) will take part in the project finance deal to support H2 Green Steel’s large-scale production facility in Northern Sweden. The EIB will contribute €314 million, of which €200 backed by a guarantee from the European Commission under the InvestEU programme, and €114 million of intermediated financing to be provided through commercial banks participating in the project financing. The Nordic Investment Bank will provide €57 million to the project finance package, of which €9 million supported under InvestEU.
Committee for Medicinal Products for Human Use (CHMP): 22-25 January 2024, European Medicines Agency, Amsterdam, the Netherlands, from 22 January 2024 to 25 January 2024
European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, from 27 February 2024 to 28 February 2024
Contract notice: 2023/S 132-421019 The post Passengers and Railway Workers Perspective in Rail Transformation (LOT 1 Passenger Perspective in Rail Transformation, LOT 2 Railway Workers’ Perspective in Rail Transformation) appeared first on Europe's Rail.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of the additive consisting of Lentilactobacillus buchneri DSM 22501 as a technological feed additive to improve ensiling of 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 is not irritant to skin and eye, but owing to its proteinaceous nature it should be considered a respiratory sensitiser. No conclusions could be drawn 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.
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@ [email protected] 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