EFSA Journal最新文献

{"title":"Use and reporting of historical control data for regulatory studies","authors":"EFSA Panel on Plant Protection Products and their Residues (PPR),&nbsp;Tamara Coja,&nbsp;Pauline Adriaanse,&nbsp;Judy Choi,&nbsp;Antonio Finizio,&nbsp;Maeva Giraudo,&nbsp;Thomas Kuhl,&nbsp;Francesca Metruccio,&nbsp;Martin Paparella,&nbsp;Silvia Pieper,&nbsp;Eugenio Scanziani,&nbsp;Ivana Teodorovic,&nbsp;Paul Van der Brink,&nbsp;Peter Craig,&nbsp;Bertrand Desprez,&nbsp;Ian Dewhurst,&nbsp;Emily McVey,&nbsp;Arianna Chiusolo,&nbsp;Anna Lanzoni,&nbsp;Sara Levorato,&nbsp;Laura Martino,&nbsp;Tommaso Giorgi,&nbsp;Martin Wilks","doi":"10.2903/j.efsa.2025.9576","DOIUrl":"10.2903/j.efsa.2025.9576","url":null,"abstract":"<p>The provision of historical control data (HCD) is a data requirement for pesticide active substances established by European legislation. HCD are data from studies conducted under the same or similar conditions as the toxicity study under assessment (index study). The collation, use and interpretation of HCD is currently not harmonised. The Panel on Plant Protection Products and their Residues developed this Scientific Opinion to elucidate the requirements for the use of HCD for interpretation of studies used for regulatory purposes, clarify how HCD should be compiled as part of the regulatory dossier and assist the interpretation of HCD in the context of the evaluation of regulatory studies. This Opinion proposes a stepwise, quantitative approach using a decision scheme which includes seven distinct steps grouped in three overall clusters of activity: (1) planning, (2) evaluation of the HCD and (3) use of HCD. In the planning phase, a protocol for collating the relevant HCD as well as their expected evaluation and analysis should be developed. Cluster 2 deals with the data requirements for HCD, including their use for quantitative statistical analysis. A final set of HCD is selected and the variability within and between studies is modelled. Statistical comparison of the HCD with the concurrent control data set and integration of the HCD into the analysis of the index study is carried out in cluster 3, including an influence or sensitivity analysis. To demonstrate the application of the decision scheme to different data types, three case studies have been prepared. The Opinion also offers templates to improve harmonisation for data submission and discusses confounding/covariate aspects related to HCD interpretation. Practical application of the Opinion requires a close exchange of toxicological and statistical input in the analysis of data and derivation of conclusions. It is recommended to consider this interaction between the disciplines every time submission and interpretation of HCD is planned.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9576","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144767634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New developments in biotechnology applied to animals: An assessment of the adequacy and sufficiency of current EFSA guidance for animal risk assessment","authors":"EFSA Panel on Genetically Modified Organisms (GMO),&nbsp;Josep Casacuberta,&nbsp;Francisco Barro,&nbsp;Albert Braeuning,&nbsp;Ruud de Maagd,&nbsp;Michelle M. Epstein,&nbsp;Thomas Frenzel,&nbsp;Jean-Luc Gallois,&nbsp;Frits Koning,&nbsp;Antoine Messéan,&nbsp;F. Javier Moreno,&nbsp;Fabien Nogué,&nbsp;Alan H. Schulman,&nbsp;Christoph Tebbe,&nbsp;Eve Veromann,&nbsp;Leslie Firbank,&nbsp;Debora Glandorf,&nbsp;Mette S. Herskin,&nbsp;Simon Geoffrey Lillico,&nbsp;Robin Ornsrud,&nbsp;Anna Troedsson-Wargelius,&nbsp;Michele Ardizzone,&nbsp;Paolo Lenzi,&nbsp;Ana M. Camargo,&nbsp;Nikoletta Papadopoulou,&nbsp;Reinhilde Schoonjans,&nbsp;Marika Vitali,&nbsp;Giovanni Savoini","doi":"10.2903/j.efsa.2025.9566","DOIUrl":"10.2903/j.efsa.2025.9566","url":null,"abstract":"<p>EFSA was requested by the European Commission to provide a scientific opinion on new developments in biotechnology, including new genomic techniques, as applied to animals for food, feed and other agricultural uses. A horizon-scanning exercise identified a variety of animals obtained with new genomic techniques, with the potential to reach the EU market in the short, medium and long term. No novel hazards have been identified that are linked to either the modification process or the newly introduced trait, when SDN-1, SDN-2 and comparable techniques (e.g. base editing or prime editing) were compared to established genomic techniques (EGTs) or conventional breeding. Hazards posed by SDN-3 are of the same nature as those posed by EGTs and the targeted insertion may reduce the potential hazards associated with the disruption of endogenous genes and/or regulatory elements in the recipient genome. Hazards posed by the new trait resulting from the introduced transgenic or intragenic DNA sequence are of the same nature as those posed by EGTs. Hazards posed by the new trait resulting from the introduced cisgenic DNA sequence are of the same nature as those posed by conventional breeding. Off-target mutations from genome editing are similar in nature to those from conventional breeding and do not pose novel hazards. Consequently, based on the currently available data, no new potential hazards, and thus, no new risks to humans, animals or the environment have been identified. A thorough evaluation of existing EFSA guidance documents for the risk assessment of GM animals revealed that their principles and recommendations provide the basis for assessing the risks of new genomic technique (NGT) animals for food, feed and other agricultural uses; however, the current texts cover only partially some areas (e.g. animal health and welfare) and may need updates, adaptations or enhancements on a case-by-case basis to fully address NGT-related risks.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9566","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144767635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the feed additive beta-carotene (3a160(a)) for all animal species for the renewal of its authorisation (BASF SE, DSM Nutritional Products Ltd., Europe-Asia GmbH, JYB Europe BV, NHU Europe GmbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Maria Bastos,&nbsp;Paul Brantom,&nbsp;Jürgen Gropp,&nbsp;Kettil Svensson,&nbsp;Maria Dulak-Lis,&nbsp;Jaume Galobart,&nbsp;Orsolya Holczknecht,&nbsp;Laura Iancu,&nbsp;Paola Manini,&nbsp;Fabiola Pizzo,&nbsp;Maria Vittoria Vettori,&nbsp;Eleni Gkimprixi","doi":"10.2903/j.efsa.2025.9549","DOIUrl":"10.2903/j.efsa.2025.9549","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of beta-carotene (3a160(a)) for the renewal of its authorisation as a nutritional additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of beta-carotene in animal nutrition under the approved conditions remains safe for target species, consumers and the environment. Regarding user safety, the FEEDAP Panel concludes that beta-carotene is not a skin and eye irritant and not a skin sensitiser. One preparation containing 10% beta-carotene was shown not to be a skin sensitiser. However, no conclusions on the safety for the user can be done on any other preparations. The Panel concluded there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9549","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144740493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modification of the existing maximum residue levels for fenazaquin in strawberries, sweet peppers, tomatoes and aubergines","authors":"European Food Safety Authority (EFSA),&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Luis Carrasco Cabrera,&nbsp;Irene Castellan,&nbsp;Monica del Aguila,&nbsp;Lucien Ferreira,&nbsp;Luna Greco,&nbsp;Samira Jarrah,&nbsp;Renata Leuschner,&nbsp;Andrea Mioč,&nbsp;Stefanie Nave,&nbsp;Hermine Reich,&nbsp;Silvia Ruocco,&nbsp;Alessia Pia Scarlato,&nbsp;Andrea Simonati,&nbsp;Marta Szot,&nbsp;Anne Theobald,&nbsp;Olha Timofieieva,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani,&nbsp;Elena Zioga","doi":"10.2903/j.efsa.2025.9604","DOIUrl":"10.2903/j.efsa.2025.9604","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Limited submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance fenazaquin in strawberries, sweet peppers, tomatoes and aubergines. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the requested commodities. Adequate analytical methods for enforcement are available to control the residues of fenazaquin on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues of fenazaquin and its toxicologically relevant plant metabolite 2-(4-tert-butylphenyl)ethanol (TBPE) resulting from the use of fenazaquin according to the reported agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative and affected by uncertainties pending the assessment of the data gaps identified in the review of the existing MRLs and due to the limited information on TBPE residue concentrations associated to existing CXLs implemented as EU MRLs in the EU legislation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9604","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of a feed additive consisting of a tincture derived from the leaves or aerial parts of Thymus serpyllum L. (wild thyme tincture) for use in all animal species (FEFANA asbl)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Maria de Lourdes Bastos,&nbsp;Emilio Benfenati,&nbsp;Paul Brantom,&nbsp;Andrew Chesson,&nbsp;Josef Schlatter,&nbsp;Johannes Westendorf,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2025.9551","DOIUrl":"10.2903/j.efsa.2025.9551","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves or aerial parts of <i>Thymus serpyllum</i> L. (wild thyme tincture) when used as a sensory additive in feed and in water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.0%. The product contains on average 0.083% (w/w) total polyphenols (of which 0.0222% are flavonoids). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of wild thyme tincture is safe at the proposed use level of 500 mg/kg complete feed for ornamental fish. For the other species the calculated safe concentrations in complete feed are: 71 mg/kg for chickens for fattening, 106 mg/kg for laying hens, 96 mg/kg for turkeys for fattening, 154 mg/kg for pigs for fattening, 128 mg/kg for piglets, 187 mg/kg for sows, 321 mg/kg for veal calves, 282 mg/kg for cattle for fattening, sheep/goats and horses, 183 mg/kg for dairy cows, 113 mg/kg for rabbits, 322 mg/kg for salmonids, 338 mg/kg for dogs and 282 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 71 mg/kg complete feed. No safety concerns were identified for the consumer and the environment from the use of the additive in animal feed. Regarding user safety, the additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Any exposure is considered a risk. Since the leaves of <i>T. serpyllum</i> are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was necessary.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9551","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Plain Language Summary of the Scientific opinion on welfare of animals kept for fur production","authors":"","doi":"10.2903/j.efsa.2025.p230703","DOIUrl":"10.2903/j.efsa.2025.p230703","url":null,"abstract":"","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.p230703","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of Salvia officinalis L. (sage tincture) for use in all animal species (FEFANA asbl)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Maria de Lourdes Bastos,&nbsp;Emilio Benfenati,&nbsp;Paul Brantom,&nbsp;Andrew Chesson,&nbsp;Josef Schlatter,&nbsp;Johannes Westendorf,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2025.9545","DOIUrl":"10.2903/j.efsa.2025.9545","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves of <i>Salvia officinalis</i> L. (sage tincture) when used as a sensory additive in feed and in water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.76%. The product contains on average 0.314% (w/w) total polyphenols (of which 0.0458% are flavonoids). Estragole was not detected in the tincture. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of sage tincture is safe at the proposed use level of 500 mg/kg complete feed for ornamental fish. For the other species the calculated safe concentrations in complete feed are: 35 mg/kg for chickens for fattening, 52 mg/kg for laying hens, 47 mg/kg for turkeys for fattening, 75 mg/kg for pigs for fattening, 62 mg/kg for piglets, 91 mg/kg for sows, 156 mg/kg for veal calves, 137 mg/kg for cattle for fattening, sheep/goats and horses, 89 mg/kg for dairy cows, 55 mg/kg for rabbits, 156 mg/kg for salmonids, 164 mg/kg for dogs and 137 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 35 mg/kg complete feed. No safety concerns were identified for the consumer and the environment from the use of the additive in animal feed. Regarding user safety, the additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Any exposure is considered a risk. Since the leaves of <i>S. officinalis</i> are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was necessary.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9545","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme asparaginase from the non-genetically modified Saccharomyces cerevisiae strain ARY-2","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Daniele Cavanna,&nbsp;Silvia Peluso,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9532","DOIUrl":"10.2903/j.efsa.2025.9532","url":null,"abstract":"<p>The asparaginase (L-asparagine amidohydrolase, EC 3.5.1.1) is produced by the non-genetically modified <i>Saccharomyces cerevisiae</i> strain ARY-2 by Renaissance BioScience Corporation. The food enzyme is not separated from the yeast cells during the enzyme production. The food enzyme is intended to be used to reduce acrylamide formation during food processing at high temperature and low moisture conditions by hydrolysing asparagine. Dietary exposure was estimated to be up to 32.246 mg TOS/kg body weight per day in European populations. Toxicity tests were considered unnecessary by the Panel because the production strain was considered safe and no issues of concern resulting from the food enzyme manufacturing process were identified. A search for the homology of the amino acid sequence of the asparaginase 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. 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.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9532","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Welfare of American mink, red and Arctic foxes, raccoon dog and chinchilla kept for fur production","authors":"EFSA Panel on Animal Health and Welfare (AHAW),&nbsp;Søren Saxmose Nielsen,&nbsp;Julio Álvarez,&nbsp;Anette Ella Boklund,&nbsp;Sabine Dippel,&nbsp;Fernanda Dorea,&nbsp;Jordi Figuerola,&nbsp;Miguel Ángel Miranda Chueca,&nbsp;Virginie Michel,&nbsp;Eleonora Nannoni,&nbsp;Romolo Nonno,&nbsp;Anja B. Riber,&nbsp;Karl Stahl,&nbsp;Jan Arend Stegeman,&nbsp;Hans-Hermann Thulke,&nbsp;Frank Tuyttens,&nbsp;Christoph Winckler,&nbsp;Maria Díez-León,&nbsp;Sandra Edwards,&nbsp;Angela Schwarzer,&nbsp;Beatrice Benedetti,&nbsp;Denise Candiani,&nbsp;Eleonora Cattaneo,&nbsp;Michaela Hempen,&nbsp;Eliana Lima,&nbsp;Claudia Millán Caravaca,&nbsp;Neil J. Tirchett,&nbsp;Yves Van der Stede,&nbsp;Marika Vitali,&nbsp;Mette S. Herskin","doi":"10.2903/j.efsa.2025.9519","DOIUrl":"10.2903/j.efsa.2025.9519","url":null,"abstract":"<p>This Scientific Opinion (SO) addresses a mandate from the EC regarding welfare of the following animals when farmed for their fur: (i) American mink (<i>Neogale vison</i> or <i>Neovison vison</i>), (ii) Red fox (<i>Vulpes vulpes</i>, also known as ‘silver fox’), (iii) Arctic fox (<i>Vulpes lagopus</i>, also known as ‘blue fox’), (iv) Raccoon dog (<i>Nyctereutes procyonoides</i>, also known as ‘Finnraccoon’) and (v) Chinchilla (<i>Chinchilla lanigera</i>). The request was to identify the most relevant welfare consequences (WCs) for each species and to determine whether these could be prevented or substantially mitigated in the current husbandry systems. ‘Current system’ refers strictly to the cage systems and cage dimensions as described in the EFSA Technical report produced under this mandate, as there was no or very limited information available on animals kept in alternative farming systems. Using information obtained from a review of literature, consultations with stakeholders and consideration by EFSA experts, the SO addresses for each species these WCs along with their underlying hazards and potential preventive or mitigating measures. In all species, Restriction of movement, Inability to perform exploratory or foraging behaviour, and Sensorial under- and overstimulation were selected as the most relevant WCs, sharing common hazards linked to current cage size and barrenness. Species-specific WCs include: soft tissue lesions and integument damage (mink), and handling stress (mink and foxes); locomotory disorders (Arctic fox); group stress (red fox), locomotory disorders and isolation stress (raccoon dog); and inability to perform comfort behaviour, resting problems and predation stress (chinchilla). In the majority of cases, it is concluded that neither prevention nor substantial mitigation of the identified WCs is possible in the current system. The SO also includes conclusions on limited or substantial mitigation measures in the current system and, when not possible, on substantial mitigating measures which would require a change to a different system.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9519","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of a feed additive consisting of a tincture derived from the flowers of Lavandula angustifolia Mill. (lavender tincture) for use in all animal species (FEFANA asbl)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Maria de Lourdes Bastos,&nbsp;Emilio Benfenati,&nbsp;Paul Brantom,&nbsp;Andrew Chesson,&nbsp;Josef Schlatter,&nbsp;Johannes Westendorf,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2025.9550","DOIUrl":"10.2903/j.efsa.2025.9550","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the flowers of <i>Lavandula angustifolia</i> Mill. (lavender tincture) when used as a sensory additive in feed and in water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.66%. Lavender tincture contains on average 0.213% (w/w) total polyphenols (of which 0.0259% are flavonoids). Methyleugenol (0.0008%) was detected in the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of lavender tincture is very unlikely to induce adverse effects in long-living and reproductive animals and is of no safety concern for species for fattening at the following concentrations in complete feed: 60 mg/kg for chickens for fattening, 89 mg/kg for laying hens, 81 mg/kg for turkeys for fattening, 129 mg/kg for pigs for fattening, 108 mg/kg for piglets, 157 mg/kg for sows, 269 mg/kg for veal calves, 237 mg/kg for cattle for fattening, sheep/goats and horses, 154 mg/kg for dairy cows, 95 mg/kg for rabbits, 270 mg/kg for salmonids, 284 mg/kg for dogs, 237 mg/kg for cats and 500 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to induce adverse effects at 60 mg/kg complete feed. No safety concern would arise for the consumer and the environment from the use of the additive in animal feed. Regarding user safety, the additive under assessment 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 methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the flowers of <i>L. angustifolia</i> are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was necessary.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9550","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}