HaDEA has published the EU4Health call for tenders HADEA/2025/CPN/0008 - Multiple sourcing Framework Contracts to speed up the development of and access to innovative medical countermeasures - Next-Generation Influenza Vaccines.

Last week the team of the official portal for European data delivered the EU Open Data Days 2025, a two day conference that brings together data enthusiasts, policymakers, researchers, and industry leaders to discuss and showcase the power of open data. Discover HaDEA-managed projects in this field.

HaDEA has published the EU4Health call for tenders HADEA/2025/OP/0012 - Multiple framework contracts in cascade for legal support services for the compliance assessment of national transposing measures in the health and food safety areas in the context of the enlargement.

Health Union Fellowship - Video clip

HERA review: Taking stock to reinforce health security in the EU

EU4Health call for tenders to develop point-of-care diagnostic medical devices for antimicrobial susceptibility testing

A new plug-in, to be made available as open source, provides on-the-fly translations of Better Training for Safer Food ACADEMY content

PHOTORAMA is an EU-funded project focused on creating a circular model for the photovoltaic (PV) industry. By developing advanced recycling technologies, it aims to recover critical materials from end-of-life solar panels and bridge the gap between manufacturing and recycling.

HaDEA is funding a number of projects working in the field of environment and health at the workplace.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High risk plants, plant products and other objects’. This Scientific Opinion covers plant health risks posed by plants of Populus alba, Populus nigra and Populus tremula imported from the United Kingdom (UK) as: (a) 1‐ to 7‐year‐old bare root plants, (b) 3‐ to 15‐year‐old plants in pots, (c) 1‐ to 2‐year‐old cell grown plants and (d) bundles of 1‐ to 2‐year‐old cuttings/graftwood (only for P. nigra and P. tremula), taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this Opinion. Two EU protected zone quarantine pests, i.e. Bemisia tabaci (European populations) and Entoleuca mammata, fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. Expert judgements were given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies between the pests evaluated, with E. mammata being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation (EKE) indicated with 95% certainty that between 9730 and 10,000 per 10,000 P. tremula rooted plants in pots (3 to 15 year old) will be free from E. mammata.

Upcoming EU4Health calls for tenders: advancing influenza and mpox vaccines, and antimicrobial susceptibility testing

HaDEA has published the EU4Health call for tenders HADEA/2025/CPN/0006 on the development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device.

24 March marks World Tuberculosis Day, an occasion to give the spotlight to HaDEA-managed projects funded under the Horizon Europe programme. These two projects are working towards new vaccine solutions and new therapies which are indispensable to combatting tuberculosis.

Presentation - The EU HTA Regulation: Webinar for health technology developers of medicinal products

On 19 March, the European Commission presented the Steel and Metals Action Plan, announced in the Clean Industrial Deal. The focus of this action plan is on lowering energy costs, creating lead markets for low-carbon products, increasing circularity and levelling the international playing field.

These are the results of the evaluation of the proposals submitted to the DIGITAL-2024-BESTUSE-TECH-07 call under the Digital Europe Programme.

These are the results of the evaluation of the proposals submitted to the DIGITAL-2024-ADVANCED-DIGITAL-07 call under the Digital Europe Programme.

Between 7 December 2024 and 7 March 2025, 743 highly pathogenic avian influenza (HPAI) A(H5) virus detections were reported in domestic (239) and wild (504) birds across 31 countries in Europe. HPAI A(H5N1) virus detections were predominant and mainly located in central, western and south-eastern Europe. Most HPAI A(H5) virus detections in wild birds concerned waterfowl, particularly mute swans, barnacle geese and greylag geese. Limited secondary spread was observed among the poultry outbreaks, and outdoor poultry access remained an important risk factor at the interface between wild and domestic birds. HPAI A(H5N5) outbreaks occurred only in wild birds and were increasingly reported in waterfowl. For the first time since spring 2024, several HPAI virus detections were reported in domestic cats and wild carnivores in Europe. In the United States of America (USA), the number of dairy cattle farms reportedly affected rose to almost 1,000 in 17 States, and a different HPAI A(H5N1) virus genotype (D1.1) was reported in this species. Between 12 December 2024 and 7 March 2025, 22 new cases of avian influenza virus infection in humans were reported in the USA (12 A(H5) cases), Cambodia (two A(H5N1) cases), United Kingdom (one A(H5N1) case), and China (six A(H9N2) cases and one A(H10N3) case). Most of the A(H5) human cases (93%, n = 14/15) had reported exposure to poultry or dairy cattle prior to avian influenza virus detection or onset of illness. Considering the widespread circulation of avian influenza viruses in animal populations, human infections with avian influenza viruses remain infrequent. No evidence of human-to-human transmission has been documented during the reporting period. The risk of infection with the avian A(H5) influenza viruses of clade 2.3.4.4b currently circulating in Europe remains low for the general public in the European Union/European Economic Area (EU/EEA). The risk of infection remains low-to-moderate for those occupationally or otherwise exposed to infected animals or contaminated environments.

This technical report aims at guiding the data reporting to EFSA of analytical test results and the related metadata generated in the context of the One Health surveillance activities carried out by Member States under their direct grant agreements. The objective is to explain in detail the individual data elements that are included in the EFSA Standard Sample Description version 2 (SSD2) data model. The guidance is intended to support the reporting countries in data transmission using eXtensible Markup Language (XML) data file transfer through the Data Collection Framework (DCF) according to the protocol described in the EFSA Guidance on Data Exchange version 2 (GDE2). The data elements are explained, including information about data type, list of allowed terms and associated business rules. Instructions about how to report common sampling schemes are also provided to ensure harmonised reporting among countries.

The risk assessment (RA) requirements for genetically modified plants (GMPs) are defined in Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011). When a GMP is developed to silence transcripts by RNA interference (RNAi), some specific additional analysis needs to be provided by the applicant. This guidance describes the requirements and recommendations for the GMP applications submitted to EFSA. It covers the molecular characterisation, focusing on bioinformatic analysis and confirmation of the trait, as well as the food and feed safety and dietary exposure assessment of RNAi‐based GMPs. This document replaces the GMO panel strategy for the risk assessment of RNAi off targets in plants, described in Annex II to the minutes of the 118th Plenary meeting of the Scientific Panel on GMO and takes into account the current knowledge on the mechanisms of RNAi in plants.

The applicant Corteva Agriscience meptyldinocap International Sàrl submitted a request to the competent national authority in Croatia to evaluate the confirmatory data provided in response to the data gaps that were identified for meptyldinocap in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. Moreover, the applicant requested to raise the existing maximum residue levels (MRLs) for meptyldinocap in table and wine grapes. To address the data gap on storage stability for the metabolite 2,4‐DNOP in high acid and in high water commodities, a storage stability study in high acid commodities was provided for meptyldinocap and 2,4 DNOP. This information allowed to confirm the validity of residue data on grapes and strawberries assessed in the MRL review. Information on the nature of residues in rotational crops and on the storage stability of metabolite 2,4‐DNOP in high water content matrices were not provided within this application. In addition, new residue trials on grapes, compliant with existing EU GAPs were submitted which resulted in a higher MRL proposal than the one tentatively derived by the MRL review. EFSA concluded that the identified data gaps were satisfactorily addressed for table and wine grapes, partially addressed for strawberries and not addressed for melons and watermelons. Furthermore, the new information provided required a revision of the existing MRLs for table and wine grapes. The consumer risk assessment performed for meptyldinocap in the MRL review was revised accordingly and a consumer concern was not identified.

In 2022, EFSA was mandated by the European Commission's Directorate‐General for Health and Food Safety (M‐2022‐00070) to provide technical assistance regarding the list of Union quarantine pests qualifying as priority pests, as specified in Article 6(2) of Regulation (EU) 2016/2031 on protective measures against plant pests. As part of Task C, EFSA conducted comprehensive expert knowledge elicitations on candidate priority pests, focusing on the lag period, rate of expansion and impact on production (yield and quality losses) and the environment. This report provides the rationale for the dataset on Thaumatotibia leucotreta, delivered to the European Commission's Joint Research Centre, to feed into the Impact Indicator for Priority Pest (I2P2) model and complete the pest prioritisation ranking exercise.

This document provides the conclusions of the pest survey card that was prepared in the context of the EFSA mandate on plant pest surveillance (M‐2020‐0114) at the request of the European Commission. The full pest survey card for palm lethal yellowing phytoplasmas and their vector Haplaxius crudus is published and available online in the EFSA Pest Survey Card gallery at the following link and will be updated whenever new information becomes available: https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/palm-…

This document provides the conclusions of the pest survey card that was prepared in the context of the EFSA mandate on plant pest surveillance (M‐2020‐0114) at the request of the European Commission. The full pest survey card for Rhynchophorus ferrugineus and R. palmarum is published and available online in the EFSA Pest Survey Card gallery at the following link and will be updated whenever new information becomes available: https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/rhync…

This document provides the conclusions of the pest survey card that was prepared in the context of the EFSA mandate on plant pest surveillance (M‐2020‐0114) at the request of the European Commission. The full pest survey card for Paysandisia archon is published and available online in the EFSA Pest Survey Card gallery at the following link and will be updated whenever new information becomes available: https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/paysa…

Recording and presentation - EUHPP Live Webinar: Introducing the AUGMENT Biosimilars Project - Goals, learnings and next steps (18 March 2025)

Genetically modified maize DAS1131 was developed to confer resistance to certain susceptible lepidopteran pests, as well as tolerance to glyphosate herbicide, these properties were achieved by introducing the cry1Da2 and dgt‐28 epsps 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 DAS1131 and its conventional counterpart needs further assessment, except for crude fat in grain which does not raise safety and nutritional concerns. The Panel on Genetically Modified Organisms (GMO Panel) does not identify safety concerns regarding the toxicity and allergenicity of the Cry1Da2 and DGT‐28 EPSPS proteins as expressed in maize DAS1131 and finds no evidence that the genetic modification would change the overall allergenicity of maize DAS1131. In the context of this application, the consumption of food and feed from maize DAS1131 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DAS1131 is as safe as the conventional counterpart and the non‐GM maize varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of release of maize DAS1131 into the environment, including viable grains, 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 DAS1131. The GMO Panel concludes that maize DAS1131 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.

Today the Italian farmers’ association Coldiretti organised a demonstration in Parma. EFSA’s senior management met with representatives of the organisation.“Today, together with EFSA's Director, Bernhard Url, we met with representatives of Coldiretti for a discussion about food derived from cell cultures and precision fermentation,” said Alberto Spagnolli, EFSA's Senior Policy Coordinator.We had a constructive discussion which, in our view, helped to clarify some of the concerns and requests raised by Coldiretti, and EFSA's approach to safety assessments.We highlighted how Coldiretti's request...

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus niger strain XYL by DSM Food specialties. An evaluation of this food enzyme was made previously, in which EFSA could not conclude on its safety due to data gaps in a genotoxicity test. Subsequently, the applicant provided new data. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure was estimated to be up to 0.281 mg (total organic solids) TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 4095 mg TOS/kg bw per day for males and of 4457 mg TOS/kg bw per day for females, respectively, the highest doses tested. When compared with the estimated dietary exposure, it results in a margin of exposure of at least 14,573. A search for the homology of the amino acid sequence of the endo‐1,4‐β‐xylanase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the new data and the data provided previously, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of chromium chelate of DL‐methionine (Availa® Cr) for salmonids. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for salmonids at the maximum recommended of 600 mg additive/kg complete feed (corresponding to 0.6 mg Cr/kg complete feed). The use of the additive in animal feed is considered safe for the consumers and the environment. The additive is not an eye nor skin irritant. Due to the presence of nickel, the additive is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel concludes that the additive may have the potential to be efficacious in improving the performance of salmonids at 200 mg additive/kg complete feed (0.2 mg Cr/kg complete feed).

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐D‐xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain DP‐Ezd119 by Genencor International B.V. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.085 mg total organic solids/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the endo‐1,4‐β‐xylanase to known allergens was made, and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

As the world celebrates Global Recycling Day on 18 March, discover eight EU-funded projects managed by HaDEA that are taking concrete steps towards a more circular economy and reducing waste.

EU4Health call for tenders to speed up the access to and uptake of an Mpox vaccine

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Albaugh Europe Sàrl submitted a request to the competent national authority in Slovenia to modify the existing maximum residue level (MRL) for the active substance acetamiprid in honey. The data submitted in support of the request were found to be sufficient to derive a new MRL proposal for honey. Adequate analytical methods for enforcement are available to control the residues of acetamiprid in honey at the validated limit of quantification (LOQs) of 0.01 and 0.05 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of acetamiprid residues in honey from existing critical agricultural practices on melliferous crops is unlikely to present a risk to consumer health.

Mosquitoes are the most dangerous creature on our planet. Join us as we explore how insects spread disease and what we can all do about it!   

Parma, Italy, 2026-11-18 to 2026-11-18 , 2026-11-19 to 2026-11-19 The 133rd Plenary meeting of the Scientific Committee will take place from 18 to 19 November 2026.

Parma, Italy, 2026-11-18 to 2026-11-18 , 2026-11-19 to 2026-11-19 The 133rd Plenary meeting of the Scientific Committee will take place from 18 to 19 November 2026.

Update - MDCG 2020-16 rev.4 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (March 2025)

Parma, Italy, 2026-07-07 to 2026-07-07 , 2026-07-08 to 2026-07-08 The 131st Plenary meeting of the Scientific Committee will take place from 7 to 8 July 2026.

Parma, Italy, 2026-07-07 to 2026-07-07 , 2026-07-08 to 2026-07-08 The 131st Plenary meeting of the Scientific Committee will take place from 7 to 8 July 2026.

Online, 2026-05-07 to 2026-05-07 , 2026-05-08 to 2026-05-08 The 130th Plenary meeting of the Scientific Committee will take place from 7 to 8 May 2026.

Online, 2026-05-07 to 2026-05-07 , 2026-05-08 to 2026-05-08 The 130th Plenary meeting of the Scientific Committee will take place from 7 to 8 May 2026.

Online, 2026-02-25 to 2026-02-25 , 2026-02-26 to 2026-02-26 The 129th Plenary meeting of the Scientific Committee will take place from 25 to 26 February 2026.

Online, 2026-02-25 to 2026-02-25 , 2026-02-26 to 2026-02-26 The 129th Plenary meeting of the Scientific Committee will take place from 25 to 26 February 2026.

To evaluate project proposals competing for EU funding in 2025-2027, HaDEA is looking for independent health experts.

European Commission announces High-Level Event on the European Health Data Space

Agenda - 102nd meeting of the Pharmaceutical Committee (1 April 2025)

In 2022, EFSA was mandated by the European Commission's Directorate‐General for Health and Food Safety (M‐2022‐00070) to provide technical assistance on the list of Union quarantine pests qualifying as priority pests, as specified in Article 6(2) of Regulation (EU) 2016/2031 on protective measures against plant pests. As part of Task C, EFSA conducted comprehensive expert knowledge elicitations for candidate priority pests on the lag period, rate of expansion and impact on production (yield and quality losses) and the environment. This report provides the rationale for the dataset on the three Candidatus Liberibacter species associated with citrus greening disease, delivered to the European Commission's Joint Research Centre, to feed into the Impact Indicator for Priority Pest (I2P2) model and complete the pest prioritisation ranking exercise.

In 2022, EFSA was mandated by the European Commission's Directorate‐General for Health and Food Safety (M‐2022‐00070) to provide technical assistance on the list of Union quarantine pests qualifying as priority pests, as specified in Article 6(2) of Regulation (EU) 2016/2031 on protective measures against plant pests. As part of Task C, EFSA conducted expert knowledge elicitations for candidate priority pests, focusing on the lag period, expansion rate and impact on production (yield and quality losses) and the environment. This report provides the rationale for the dataset on Bactrocera dorsalis, delivered to the European Commission's Joint Research Centre, to feed into the Impact Indicator for Priority Pest (I2P2) model and complete the pest prioritisation ranking exercise.

The European Food Safety Authority assesses the safety of feed additives used in aquaculture, including the safety of the feed additives for the environment. The sediment compartment is frequently the environmental area most at risk from these chemicals. The objective of Task 1.1, as reported herein, was to develop standard exposure scenarios as part of the project titled “Modelling the Environmental Concentrations of Chemical Substances in Marine Sediment Resulting from Their Application via Feed in Marine Aquaculture.” This report presents the findings from Task 1.1. To calculate the predicted environmental concentrations (PEC), the model requires input data from three key areas; (1) the chemicals used in the feed, (2) aquaculture production, and (3) oceanographic conditions. In Task 1.1, information relevant to these topics was assessed, and based on the findings, a generalized standard exposure scenario for PEC calculation has been developed. The development of exposure scenarios has been tailored to fulfil the requirements for Phase I screening of the environmental risk assessment set by EFSA. Consequently, data on typical aquaculture species, representative model areas, and common production and oceanographic conditions have been selected. The data collection focused on information necessary for the model to ultimately calculate the initial PEC based on a worst‐case scenario. Some of the information assessed and collected can in addition be utilized in a Phase II (higher tier) environmental risk assessment. By implementing the proposed exposure scenarios, as outlined throughout this report, Task 1.1 lays the groundwork for the development of the conceptual model in Task 1.2. The conceptual model will be designed for flexibility, allowing for both Phase I and Phase II assessments, and enabling easy addition and update of new information.

In 2022, EFSA was mandated by the European Commission's Directorate‐General for Health and Food Safety (M‐2022‐00070) to provide technical assistance on the list of Union quarantine pests qualifying as priority pests, as specified in Article 6(2) of Regulation (EU) 2016/2031 on protective measures against plant pests. As part of Task C, EFSA conducted expert knowledge elicitations for candidate priority pests, focusing on the lag period, expansion rate and impact on production (yield and quality losses) and the environment. This report provides the rationale for the dataset on Anastrepha ludens, delivered to the European Commission's Joint Research Centre, to feed into the Impact Indicator for Priority Pest (I2P2) model and complete the pest prioritisation ranking exercise.

In 2022, EFSA was mandated by the European Commission's Directorate‐General for Health and Food Safety (M‐2022‐00070) to provide technical assistance regarding the list of Union quarantine pests qualifying as priority pests, as specified in Article 6(2) of Regulation (EU) 2016/2031 on protective measures against plant pests. As part of Task C, EFSA conducted comprehensive expert knowledge elicitations on candidate priority pests, focusing on the lag period, rate of expansion and impact on production (yield and quality losses) and the environment. This report provides the rationale for the dataset on Phyllosticta citricarpa, delivered to the European Commission's Joint Research Centre, to feed into the Impact Indicator for Priority Pest (I2P2) model and complete the pest prioritisation ranking exercise.

Following the implementation of the Transparency Regulation in 2021, which also amended EFSA's Founding Regulation, the European Commission (EC) is conducting an Evaluation of EFSA's performance for the period from 2017 to 2024. 

HaDEA has published the call for tenders HADEA/2025/OP/0013 - Speeding up the access to and/or uptake of innovative Mpox vaccines.

In 2022, EFSA was mandated by the European Commission's Directorate‐General for Health and Food Safety (M‐2022‐00070) to provide technical assistance regarding the list of Union quarantine pests qualifying as priority pests, as specified in Article 6(2) of Regulation (EU) 2016/2031 on protective measures against plant pests. As part of Task C, EFSA conducted comprehensive expert knowledge elicitations on candidate priority pests, focusing on the lag period, rate of expansion and impact on production (yield and quality losses) and the environment. This report provides the rationale for the dataset on Bursaphelenchus xylophilus, delivered to the European Commission's Joint Research Centre, to feed into the Impact Indicator for Priority Pest (I2P2) model and complete the pest prioritisation ranking exercise.

Minutes - Joint meeting of the Expert Group and National Contact Points’ Sub-Group (11-12 December 2024)

Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)

HaDEA has published the EU4Health Prior Information Notice HADEA/2025/CPN/0008-PIN - Multiple sourcing Framework Contracts to speed up the development of and access to innovative medical countermeasures - Next-Generation Influenza Vaccines.

Questions and Answers on the Critical Medicines Act

Commission proposes Critical Medicines Act to bolster the supply of critical medicines in the EU

SCCS - Draft Agenda of the 10th plenary meeting, Luxembourg, 27 March 2025

Recording and presentation - EUHPP Live Webinar: Mycotoxin risks in Europe and the potential impacts of climate change (10 March 2025)

Presentation and recording - EUHPP webinar on European Health Data Space (3/3): Implementation and governance – who does what? (6 March 2025)

The Commission has launched a second call for EURLs for high-risk IVDs

Registration - The EU HTA Regulation: Webinar for health technology developers of medicinal products (21 March 2025, 12:30-14:30 (CET))

SCCS - Minutes of the Working Group meeting on Methodologies of 17 February 2025

SCCS - Minutes of the Working Group meeting on Cosmetic Ingredients of 19-20 February 2025

Registration - EUHPP Live Webinar: Introducing the AUGMENT Biosimilars Project - Goals, learnings and next steps (18 March 2025, 11.00-12.00 CET)

Registration - EUHPP webinar on European Health Data Space (3/3): Implementation and governance – who does what? (6 March 2025, 10:00 - 11:30 (CET))

Regulation on the European Health Data Space published

Resistance to commonly used antimicrobials remains persistently high in both humans and animals for Salmonella and Campylobacter, according to the latest EFSA and ECDC report on AMR. 

Regulation (EU) 2025/327 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847

Frequently Asked Questions on the European Health Data Space

Agenda and registration - EUHPP Live Webinar: Mycotoxin risks in Europe and the potential impacts of climate change (10 March 2025, 14.00-15.00 CET)

Flash report - Member State Coordination Group on HTA (HTACG) (28 February 2025)

On World Obesity Day, check out how EU-funded projects under HaDEA’s remit are helping to fight childhood and adolescent obesity. 

Recording and presentation - EUHPP webinar on European Health Data Space (2/3): Secondary Use of health data (27 February 2025)

Presentation and recording - EUHPP Live Webinar: Union prevention, preparedness and response plan (28 February 2025)

On Rare Disease Day, HaDEA interviewed professor Luca Sangiorgi, Coordinator of ERN BOND, the European Reference Network of Rare Bone Disorders, and Chair of the ERN Coordinators Group, which is the governing board of the 24 ERNs.

Watch our latest testimonial videos about innovative solutions and achievements of three Horizon Europe projects managed by HaDEA. The videos feature the projects MULTHEM, RECREATE and SUSPENS, showcasing their cutting-edge work in developing sustainable and lightweight materials.

On Rare Disease Day, HaDEA interviewed Sarah Zohar, coordinator of the EU-funded project INVENTS, and Florence Guillot, representative of the French National Research Agency in the the ERA-Net E-Rare-3 project, to shed light on their projects.

It is with extreme sadness that we learnt of the unexpected passing of our dear colleague, Konstantinos Koutsoumanis, yesterday.

During the first half of 2025, Poland is holding the rotating presidency of the Council of the European Union for the second time. As president, Poland is steering work across all levels of the Council’s operations, aiming to foster collaboration and consensus among EU Member States.

HaDEA is gearing up for the Mobile World Congress (MWC) 2025, happening from 3 to 6 March at Fira Gran via in Barcelona. As the world’s biggest event for the mobile communications industry, MWC brings together over 100 000 companies, government representatives, investors, and startups.

In EFSA’s yearly report on residues of veterinary medicinal products in live animals and animal products, the trend continued for high compliance with official limits.

EFSA has released an update of its Xylella species host plant database, which tracks plant species affected by the plant pathogen Xylella fastidiosa.

While AI offers many exciting benefits and opportunities, like increased efficiency and the potential for groundbreaking innovations, it also raises serious ethical and societal concerns, especially for children and young people—ranging from data privacy to misuse of AI’s technical capabilities.

HaDEA has published “End-to-end Earth observation systems and services: an overview of EU Space research projects supporting the development of Earth observation”. This publication presents a selection of projects that are bolstering the competitiveness of the European space sector.

Online, 2026-09-23 to 2026-09-23 , 2026-09-24 to 2026-09-24 The 132nd Plenary meeting of the Scientific Committee will take place from 23 to 24 September 2026.

Online, 2026-09-23 to 2026-09-23 , 2026-09-24 to 2026-09-24 The 132nd Plenary meeting of the Scientific Committee will take place from 23 to 24 September 2026.

The latest report on the Raw Materials Information System (RMIS) is now available, providing crucial insights into the role of advanced materials in critical raw material (CRM) reduction.

On 4 February, World Cancer Day, HaDEA organised a project showcase event on 'Fostering synergies to beat cancer: The impact of EU-funded projects'. 

HaDEA has published the Prior Information Notice HADEA/2025/OP/0013-PIN for the EU4Health call for tenders to speed up the access to and/or uptake of innovative Mpox vaccines.

HaDEA has published the Prior Information Notice for the EU4Health call for tenders on multiple framework contracts in cascade for legal support services for the compliance assessment of national transposing measures in the health and food safety areas in the context of the enlargement.

HaDEA has published the Prior Information Notice HADEA/2025/CPN/0006-PIN for the upcoming publication of the EU4Health call for tenders on the development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device.

Connecting Europe Facility - Digital Call 4 closed on 13 February with a budget of €233 million for 5G Large-Scale Pilots and Backbone connectivity for Digital Global Gateways. It drew an impressive total of 321 partners responding with 85 proposals.

What is the reality of being a female scientist? How far have we come in ensuring women’s voices are the norm? Join us as we explore role models, motherhood and barriers still to be overcome!  

Safer Internet Day is all about empowering people, especially children and young people, to navigate the digital world safely and positively. From tackling cyberbullying to understanding social networking and digital identity, the campaign highlights key online challenges and emerging concerns.

Combining disinfection treatments and water replenishment can help maintain the microbiological quality of the water used in processing such products.

For the first time, the five EU health and environment agencies – EFSA, ECDC, ECHA, EEA and EMA[1]– supported by the JRC, reviewed how the use of azole substances outside human medicine affects public health.Azole medicines are essential for treating aspergillosis, a serious infection caused by Aspergillus fungi. However, these fungi are increasingly becoming resistant to azole therapies, making treatment less effective.Azole substances are widely used in plant protection products (‘pesticides’) to control fungal diseases in agriculture and horticulture, as veterinary medicines to treat fungal...

On World AIDS Day, the EUDA is showcasing a new resource outlining key steps to be taken when launching surveys to monitor HIV and viral hepatitis in people who inject drugs.  The Drug-related infectious diseases (DRID) technical protocol – surveys on HIV and viral hepatitis in people who inject drugs includes sections on:  planning and implementing surveys; conducting the study; sampling, recruitment and study sites; specimen collection and testing; data collection, management and analysis; ethical considerations and data protection; logistical aspects; reporting and…

Source : © European Union, 2024 - EP

Source : © European Union, 2024 - EP

Source : © European Union, 2024 - EP

The first European Conference on Drug-Related Violence drew to a close today, culminating in a powerful Call to action delivered by EUDA Executive Director Alexis Goosdeel. Over two days, leading experts and policymakers engaged in dynamic discussions, addressing the multifaceted challenges of this phenomenon. The issues explored ranged from public safety and health implications, to responses and innovative strategies and interventions. The focus of the event was how to break the cycle of drug-related violence and build a better future. The conference's closing session featured…

The objective of this opinion was to determine if any wild caught fish species, originating from specific fishing grounds and consumed in the EU/EFTA could be considered free of zoonotic parasites. In this Opinion the term ‘fishery products’ only refers to fresh finfish. As there are multiple fish species and numerous potential parasites, Anisakis sp. was used as an indicator of zoonotic parasites in marine areas. This parasite species is particularly suited as it is common in marine environments, capable of infecting multiple fish species and is the subject of the majority of published studies. On the rare occasion where Anisakis sp. data were not available, or all tests were negative, other parasites such as Contracaecum osculatum (s.l.) and/or Phocanema spp. were considered. In freshwater systems, all zoonotic parasites were investigated. Consumption, import and landing data were used to determine the most relevant fish species and, where possible, the source fishing areas were identified. The most commonly consumed wild caught fish species in the EU/EFTA include tuna, cod, Alaskan pollock, hake, herring, sardines, mackerel, trout and saithe. Although the majority of these fish are caught in the Atlantic Ocean, the Mediterranean and the Black Sea (37) as well as several areas in the Indian Ocean, imported fish may originate from any global fishing areas, with the exception of Antarctica. Based on the data, at least one zoonotic parasite has been reported in at least one fish species in each of the FAO marine fishing areas. Thus, due to relative low fish host specificity of the zoonotic parasites, the panel concluded that all wild caught fish species may be exposed to and infected with zoonotic parasites. The same applies to freshwater fishing areas, with many areas having multiple studies reporting the presence of zoonotic parasites in the wild caught fish species.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of a preparation of Lacticaseibacillus paracasei NCIMB 30151 as a technological 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 was no new evidence that would lead to the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions for all animal species, consumers and the environment, for which the additive is considered to remain safe. Regarding user safety, the panel concluded that L. paracasei NCIMB 30151 should be considered a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. In the absence of data, no conclusion could be drawn on the eye irritation potential of the additive. There is no need for assessing the efficacy of the additive in the context of renewal of the authorisation.

DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) No 2019/1021 as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicalsCommittee on the Environment, Public Health and Food SafetyDimitris Tsiodras Source : © European Union, 2024 - EP

DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicalsCommittee on the Environment, Public Health and Food SafetyDimitris Tsiodras Source : © European Union, 2024 - EP

Genetically modified Komagataella phaffii strain MXY0541 was developed to produce soy leghemoglobin by introducing the LGB2 coding sequence encoding leghemoglobin from soybean (Glycine max). The molecular characterisation data and bioinformatic analyses do not raise any safety concerns. The safety of soy leghemoglobin as a food additive has already been assessed by the EFSA FAF Panel (EFSA‐Q‐2022‐00031). The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of soy leghemoglobin protein as expressed in K. phaffii, and finds no evidence that the genetic modification would change its overall allergenicity. The GMO Panel concludes that the LegH Prep derived from genetically modified K. phaffii strain MXY0541 is safe for human consumption with regard to the effects of the genetic modification. No environmental impact from the use of this product is expected regarding the recombinant DNA sequences possibly remaining in the product. The GMO Panel concludes that LegH Prep from genetically modified K. phaffii strain MXY0541 is safe with respect to potential effects on human health and the environment at the proposed use and use level as far as the impact of the genetic modification is concerned. The overall conclusion is that the genetic modification does not lead to safety issues.

The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus amyloliquefaciens strain AE‐BAA by Amano Enzyme Inc. 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 eight food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine food manufacturing processes. As the food enzyme‐total organic solids (TOS) are removed from the final foods in two food manufacturing processes, the dietary exposure to the food enzyme‐TOS was estimated only for the remaining seven processes. Dietary exposure was calculated to be up to 5.833 mg TOS/kg body weight per day in European populations. Based on the previous evaluation, the assessment of the new data and the revised dietary exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh or dried flowering stems of Salvia sclarea L. (clary sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for veal calves (milk replacers), cattle for fattening, sheep/goats, 10 mg/kg for horses, 20 mg/kg for dogs, salmonids and ornamental fish. For the other target species, the calculated safe concentrations were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 9 mg/kg for piglets, 11 mg/kg for pigs for fattening, 14 mg/kg for sows, 13 mg/kg for dairy cows, 8 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 4 mg/kg complete feed. The FEEDAP Panel considered that the use level in water of clary sage oil is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of clary sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering stems of S. sclarea is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of Saccharomyces cerevisiae CNCM I‐1077 as a zootechnical feed additive for several animal species. The additive, existing in a not‐coated and a coated form, is currently authorised for use in feed for calves, cattle for fattening, dairy cows, dairy goats and dairy sheep, lambs, all minor ruminant species for fattening and rearing, horses and camelids for fattening and rearing. This application regards the request for the extension of use in all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses, and the modification of the authorisation for lambs to reduce the minimum use level. The identity of the active agent as S. cerevisiae was confirmed. Based on the qualified presumption of safety approach and since no concerns are expected from other components, the additive is considered safe for the target species, consumers and the environment. The not‐coated form of the additive is not irritant to skin or eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. No conclusion could be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive has the potential to be efficacious when used in feed for all ruminants and camelids reared for milk production/suckling/reproduction at the minimum proposed use level of 5 × 108 CFU (colony forming unit)/kg complete feed, all minor (young) ruminant species and camelids for fattening and lambs at 1 × 109 CFU/kg complete feed, and in all Equidae species other than horses at 3 × 109 CFU/kg complete feed.

Today, the European Union Drugs Agency (EUDA) is convening the inaugural meeting of its newly established network of forensic and toxicological laboratories, a key initiative outlined in its new mandate. This network will play a critical role in supporting EU preparedness on drugs. The primary purpose of today’s meeting is to review initial progress in setting up the network and to outline its operational framework. It will also provide a platform for experts from across Europe to connect, exchange views and best practice, and explore ongoing challenges in the drugs field. The meeting will…

DRAFT OPINION on discharge in respect of the implementation of the general budget of the European Union – Commission for the financial year 2023Committee on the Environment, Public Health and Food SafetyAntonio Decaro Source : © European Union, 2024 - EP

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives (functional group: silage additives) consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively. The additives are intended for use with all types of fresh materials and for all animal species at a proposed minimum concentration of 1 × 107 colony‐forming units of E. faecium ATCC 53519/kg fresh material or 5 × 106 CFU of E. faecium ATCC 55593/kg fresh material. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy since the dry matter content of the ensiled materials at the end of the experiments was not corrected for volatiles, which led to unreliable estimation of the dry matter loss, and the lack of positive effects on any of the other parameters. The supplementary information submitted by the applicant included updated data on the dry matter loss corrected for volatiles. The results showed that, at the end of the ensiling process, the dry matter loss during the ensiling was significantly lower in the ensiled materials treated with E. faecium ATCC 53519 or ATCC 55593 compared to controls. The FEEDAP Panel concludes that the addition of E. faecium ATCC 53519 or ATCC 55593 in all types of fresh plant materials shows potential to improve the nutrient preservation of silage at the proposed conditions of use.

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 of a feed additive consisting of vitamin B2/riboflavin produced with Eremothecium ashbyi CCTCCM 2019833 intended for use as a nutritional additive (functional group: vitamins, pro‐vitamins and chemically well‐defined substances having similar effects) for all animal species. The characterisation, safety and efficacy of the additive have been already assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the target species, consumers and the users due to lack of reliable toxicological data. In the present assessment, the applicant submitted new genotoxicity and repeated dose oral toxicity studies. After the assessment of the data newly submitted, the FEEDAP Panel concluded that the use of the feed additive in animal nutrition under the conditions of use proposed is of no safety concern for the target species and the consumer. The additive is not a skin/eye irritant nor a skin sensitiser, but it is considered a respiratory sensitiser.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on a formulation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with fresh plant material with a dry matter (DM) range of 32%–65% at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material to be used for all animal species. The bacterial species B. subtilis and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strains was established, no acquired antimicrobial resistance genes of concern were detected in any of the two active agents and no evidence of toxigenic potential was found in B. subtilis DSM 33862. Therefore, the FEEDAP Panel concluded that the use of the strains as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive contains microorganisms and therefore should be considered as a potential skin and respiratory sensitiser. The additive is not irritant to skin or eyes. Inhalation and dermal exposure is considered a risk. These conclusions would apply, in principle, to any preparations containing the active agents. The FEEDAP Panel concluded that the additive containing B. subtilis DSM 33862 and L. buchneri DSM 12856 at a minimum concentration of 1 × 108 CFU/kg fresh material has the potential to extend the aerobic stability of silage prepared from fresh plant materials with a DM range of 32%–65%.

Length of video : 217'Disclaimer : The interpretation of debates serves to facilitate communication and does not constitute an authentic record of proceedings. Only the original speech or the revised written translation is authentic.Source : © European Union, 2024 - EP

Length of video : 218'Disclaimer : The interpretation of debates serves to facilitate communication and does not constitute an authentic record of proceedings. Only the original speech or the revised written translation is authentic.Source : © European Union, 2024 - EP

Length of video : 218'Disclaimer : The interpretation of debates serves to facilitate communication and does not constitute an authentic record of proceedings. Only the original speech or the revised written translation is authentic.Source : © European Union, 2024 - EP

The EFSA Panel on Food Additive and Flavourings (FAF Panel) evaluated the safety of proposed changes to the currently permitted uses of the food additive steviol glycosides (E 960a–d) and of a proposed modification of the current acceptable daily intake (ADI) from 4 mg/kg body weight (bw) per day to 6 or 16 mg/kg bw per day, expressed as steviol equivalents. Currently, steviol glycosides (E 960a–d) are authorised in the EU in 32 different food categories (FCs). An extension of use was proposed for four new uses within FC 7.2 ‘Fine bakery wares’. In addition, an increase of the maximum permitted levels (MPLs) for FC 14.1.3 ‘Fruit nectars’ and for three uses within FC 14.1.4 ‘Flavoured drinks’ was requested. Consequently, the Panel updated the exposure estimates using the protocol for assessing exposure to sweeteners, developed to consider the specificities related to consumers' exposure to this functional class of food additives. Considering the proposed extension of use and increase of the MPLs, together with the currently authorised uses (at the MPLs) of E 960a–d, the highest 95th percentiles of exposure are 4.1 and 6.9 mg/kg bw per day for infants and toddlers, respectively. Based on the currently available absorption, distribution, metabolism and excretion (ADME) dataset for steviol glycosides (E 960a–d), the Panel concluded that that there is insufficient justification to increase the current ADI of 4 mg/kg bw per day, expressed as steviol equivalents. With respect to the proposed extension of use and increase of the MPLs, the Panel concluded that the calculated, conservative, dietary exposure would result in an increased exceedance of the ADI for toddlers at the 95th percentile.

The European Union and Chile took a significant step forward in addressing drug-related challenges today, with the signing of a Working Arrangement between the European Union Drugs Agency (EUDA) and the Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)(1). The agreement was signed in Santiago de Chile by EUDA Executive Director, Alexis Goosdeel, and National Director of SENDA, Natalia Riffo Alonso. Following a favourable opinion of the European Commission, the EUDA Management Board mandated the Executive Director to sign the agreement in June 2024…

OSH events Back to events Connected Minds, Caring Workplaces: Addressing Mental Health in the Digital Era Event Details Location European Parliament, Spinelli 3G3, Brussels City Brussels Country Belgium Organisation Edenred Date 12/12/2024 Description As an official partner of EU-OSHA’s Healthy Workplaces Campaign, Edenred is organising an insightful conference to address the challenges and opportunities for mental health in today’s digital era. The event, hosted by MEP Estelle Ceulemans, will take place at the European Parliament on 12 December 2024. Brenda O’Brien, Senior Brussels Liaison Manager at EU-OSHA, will present the latest updates on the ‘Safe and healthy work in the digital age’ Campaign. She will also moderate a panel discussion on ‘Shaping Caring Workplaces in Europe for the Digital Age’, bringing together diverse perspectives on how to foster supportive and resilient workplaces across Europe.   Link You can register on this link Related resources Draft agenda

Ammonium propionate is authorised as a liquid preparation of ≥ 19% ammonium propionate, ≤ 80% propionic acid and ≤ 30% water. The applicant requested for the renewal of the authorisation of ammonium propionate when used as a feed additive for all terrestrial animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of ammonium propionate under the current authorised conditions of use is safe for the target species, the consumers and the environment. Concerning the user safety, the additive is corrosive to skin and eyes. Any exposure is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

The European Union Drugs Agency (EUDA) signed a Working Arrangement with Montenegro today in the margins of the EU-Western Balkans Ministerial Forum on Justice and Home Affairs taking place in Budva, Montenegro. The Working Arrangement was signed in Podgorica, in the presence of the European Commissioner for Home Affairs, Ylva Johansson. The signatories for Montenegro were the Minister of the Interior, Danilo Šaranović and Deputy Prime Minister for Foreign and European Affairs, Filip Ivanović, on behalf of the Ministry of Health. EUDA Executive Director Alexis Goosdeel signed on behalf of…

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the flowering tops of Thymbra capitata (L.) Cav. (Spanish type origanum oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for poultry species, 30 mg/kg for pigs and horses, 20 mg/kg for ruminants, 25 mg/kg for rabbits, dogs, cats and ornamental fish, and 125 mg/kg for salmonids. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 15 mg/kg complete feed. The FEEDAP Panel considered that the use level in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of the additive in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since T. capitata and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA‐GMO‐NL‐2015‐126). The applicant conducted a 90‐day feeding study on GM soybean MON 87705 and provided a proposal for post‐market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90‐day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment‐related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA‐GMO‐NL‐2015‐126 and in the supplementary toxicity study, is as safe as its non‐GM comparator and the non‐GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tea tree oil obtained from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long‐living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.5 mg/kg for turkeys for fattening, 1.7 mg/kg for laying hens, 2.0 mg/kg for piglets, 2.4 mg/kg for pigs for fattening, 3.1 mg/kg for sows, 5.0 mg/kg for veal calves (milk replacer) and salmonids, 4.4 mg/kg for cattle for fattening, sheep/goats and horses, 2.9 mg/kg for dairy cows, 1.8 mg/kg for rabbits, 0.9 mg/kg for cats, 5.3 mg/kg for dogs, 6.6 for crustaceans and 15 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to be of safety concern at 1.1 mg/kg complete feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. Regarding user safety, tea tree oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. It is classified as a reprotoxic substance (category 1B) following CLP criteria and should be handled accordingly. Since M. alternifolia and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh flowering tops of Lavandula angustifolia Mill. (lavender oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum proposed use levels in complete feed of 30 mg/kg for dogs and ornamental fish. For the other target species, the calculated safe concentrations were 9 mg/kg for chickens for fattening, 13 mg/kg for laying hens, 12 mg/kg for turkeys for fattening, 19 mg/kg for pigs for fattening, 16 mg/kg for piglets, 23 mg/kg for sows, 39 mg/kg for veal calves (milk replacer) and salmonids, 35 mg/kg for cattle for fattening, sheep/goats and horses, 22 mg/kg for dairy cows, 14 mg/kg for rabbits and 7 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 7 mg/kg complete feed. The use of lavender oil in water for drinking was considered safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. The use of lavender oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering tops of L. angustifolia is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Source : © European Union, 2024 - EP

MOTION FOR A RESOLUTIONpursuant to Rule 115(2) and (3) of the Rules of Procedureon the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified MON 94804, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(D099729/02 - 2024/2841(RSP))Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP

The food enzyme has four declared activities: endo‐polygalacturonase ((1–4)‐α‐d‐galacturonan glycanohydrolase (endo‐cleaving); EC 3.2.1.15), pectinesterase (pectin pectylhydrolase; EC 3.1.1.11), pectin lyase ((1–4)‐6‐O‐methyl‐α‐d‐galacturonan lyase; EC 4.2.2.10) and non‐reducing end α‐l‐arabinofuranosidase (α‐l‐arabinofuranoside non‐reducing end α‐l‐arabinofuranosidase; EC 3.2.1.55). It is produced with the non‐genetically modified Aspergillus niger strain PEC by DSM Food Specialties B.V. 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 three food manufacturing processes. Subsequently, the applicant has requested to extend its use to include four additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed from the final foods in one food manufacturing process, the dietary exposure to the food enzyme–TOS was estimated only for the remaining six processes. The dietary exposure was calculated to be up to 0.612 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (204 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 333. Based on the previous evaluation, the assessment of the new data and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

Propionic acid is currently authorised as a technological additive (functional group: silage additives) for all animal species. The applicants requested for the renewal of the authorisation of propionic acid when used as a feed additive for all terrestrial animal species. The applicants have provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of propionic acid under the current authorised conditions of use is safe for the target species, the consumers and the environment. Regarding user safety, the additive is corrosive to the skin and any exposure to users is considered a risk. 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 Spanish sage oil from the leaves of Salvia officinalis ssp. lavandulifolia (Vahl) Gams (Spanish sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level of 14 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use of Spanish sage oil in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of Spanish sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the leaves of S. officinalis ssp. lavandulifolia (Vahl) Gams is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

MOTION FOR A RESOLUTIONpursuant to Rule 115(2) and (3) of the Rules of Procedureon the draft Commission Implementing Decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP202216, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(D098501/04 - 2024/2837(RSP))Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP

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 authorisation of a preparation containing a smoke flavouring extract for cats and dogs. The applicant provided data demonstrating that the additive currently on the market does not fully comply with the conditions of authorisation, but with newly proposed specifications based on different analytical methods. Considering that the additive under assessment contains benzofuran and styrene, for which a potential concern for genotoxicity has been identified, and that the whole mixture raises a potential concern for genotoxicity, additional data would be needed to complete the assessment. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for cats and dogs. The additive is authorised for use in feed for cats and dogs, and therefore, there is no need to perform an assessment of the safety for the consumer and the environment. Regarding user safety, the additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to potential genotoxic substances may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. There was 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 a product containing endo‐1,4‐β‐xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of Trichoderma reesei (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products. The Panel also concluded that ECONASE® XT is safe for pigs for fattening, laying hens and minor poultry species at the proposed conditions of use. The use of the additive raises no safety concerns for the consumers of products derived from animals fed with the additive or for the environment. The liquid and solid forms of ECONASE® XT are non‐irritant to the skin, but only the liquid forms were confirmed as non‐irritant to the eyes and not dermal sensitisers. The Panel could not conclude on the irritation potential to the eyes and the dermal sensitisation potential for the solid forms. Due to the proteinaceous nature of the active substance, the additive is considered to be a respiratory sensitiser. The additive has the potential to be efficacious in pigs for fattening at 20,000 BXU/kg complete feed, in all laying poultry species at 12,000 BXU/kg complete feed and in minor poultry species other than laying birds at 8000 BXU/kg complete feed.

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 fumaric acid as a technological and sensory additive (functional groups: preservative and flavouring compounds, respectively) and for a new use of the additive as a technological additive (functional group: acidity regulator) for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that fumaric acid remains safe under the authorised conditions of use for the terrestrial animals, consumers and the environment. However, the Panel cannot conclude on the safety for the aquatic animals under all authorised condition of use. Fumaric acid is irritant to skin, eyes and respiratory tract, and should be considered a skin and respiratory sensitiser due to the presence of nickel. The Panel also considers that the new use of the additive as an acidity regulator under proposed conditions of use would not introduce risks not already considered. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation (for its use as preservative and flavouring compound). The Panel is not in the position to conclude on the efficacy of fumaric acid as an acidity regulator in feed.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae NCYC R618 as a zootechnical feed additive (functional group: gut flora stabiliser) for chickens for fattening and other poultry species for fattening and reared for laying. The additive has never been authorised. The strain under assessment S. cerevisiae (NCYC R618) qualifies for the qualified presumption of safety (QPS) and, consequently, the FEEDAP Panel concluded that the product is safe for the target species, the consumers and the environment. The FEEDAP Panel could not conclude on the skin and eye irritation or skin sensitisation potential of the additive. The additive should be considered a respiratory sensitiser. Due to the lack of sufficient data, the Panel cannot conclude on the efficacy of the additive under the proposed conditions of use.

DRAFT REPORT on the proposal for a directive of the European Parliament and of the Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals AgencyCommittee on the Environment, Public Health and Food SafetyDimitris Tsiodras Source : © European Union, 2024 - EP

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a Camellia oleifera C.Abel seed extract (Cosap®) as technological feed additive for all animal species except fin fish. In the absence of adequate tolerance studies in the target species or toxicological studies with the additive under assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of C. oleifera extract for the target species. The use of the additive in animal nutrition is not expected to cause concern for consumer safety. The additive is considered as irritant to the eyes and mucous membranes. No conclusions can be reached on the potential of the additive to be irritant to the skin or to be a dermal sensitiser. The use of the additive under the proposed conditions of use is considered safe for the terrestrial compartment. However, no conclusion can be reached on the safety of the additive for the environment when used in feed of aquatic animals other than fin fish. The Panel concluded that the additive has the potential to be efficacious as an emulsifier when used according to proposed conditions of use.

MOTION FOR A RESOLUTIONpursuant to Rule 115(2) and (3) of the Rules of Procedureon Commission Implementing Decision (EU) 2024/1826 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP23211 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(2024/2838(RSP))Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP

MOTION FOR A RESOLUTIONpursuant to Rule 115(2) and (3) of the Rules of Procedureon the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and eight of its sub-combinations pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(D098493/04 - 2024/2834(RSP))Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP

MOTION FOR A RESOLUTIONpursuant to Rule 115(2) and (3) of the Rules of Procedureon Commission Implementing Decision (EU) 2024/1828 renewing the authorisation for the placing on the market of feed containing, consisting of and of food and feed products produced from genetically modified maize MON 810 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and repealing Commission Implementing Decision (EU) 2017/1207(2024/2840(RSP))Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP

MOTION FOR A RESOLUTIONpursuant to Rule 115(2) and (3) of the Rules of Procedureon the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(D098497/04 - 2024/2836(RSP))Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP

MOTION FOR A RESOLUTIONpursuant to Rule 115(2) and (3) of the Rules of Procedureon Commission Implementing Decision (EU) 2024/1822 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP915635 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(2024/2839(RSP))Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP