EFSA Journal最新文献

{"title":"Evaluation of confirmatory data following the Article 12 MRL review for beta-cyfluthrin.","authors":"Giulia Bellisai, Giovanni Bernasconi, Irene Castellan, Monica Del Aguila, Lucien Ferreira, Renata Leuschner, Andrea Mioč, Marta Szot, Manuela Tiramani, Alessia Verani","doi":"10.2903/j.efsa.2026.10270","DOIUrl":"10.2903/j.efsa.2026.10270","url":null,"abstract":"<p><p>The applicant Bayer AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data for beta-cyfluthrin, which had been identified as unavailable in the framework of the maximum residue level (MRL)review under Article 12 of Regulation (EC) No 396/2005. Although cyfluthrin and beta-cyfluthrin are no longer authorised for use on edible crops within the European Union, MRLs on wheat and barley were established based on import tolerances, and the data gaps on these crops are still relevant. To address the data gaps, new studies on the magnitude of residues in wheat were submitted. The data gap on wheat was considered satisfactorily addressed. For barley however, the data gap was not addressed as the applicant did not report any new data. The new information provided may require a revision of the existing MRLs for wheat and for barley, both lowered to the enforcement limit of quantification (LOQ). The risk assessment was performed accordingly for beta-cyfluthrin (and cyfluthrin), leading to the conclusion that a risk to consumer health is unlikely for the imported commodities under assessment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10270"},"PeriodicalIF":3.8,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13421086/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148629741","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 of a feed additive consisting of guar gum for all animal species (AIPG-Association for International Promotion of Gums).","authors":"Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Giovanna Martelli, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Katerina Theodoridou, Maria Vittoria Vettori, Jaume Galobart, Jordi Ortuño Casanova, Matteo L Innocenti, Jürgen Gropp","doi":"10.2903/j.efsa.2026.10241","DOIUrl":"10.2903/j.efsa.2026.10241","url":null,"abstract":"<p><p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the follow-up application for re-evaluation of guar gum as a technological additive for all animal species. In the previous opinion, the FEEDAP Panel could not conclude on the safety for long-living and reproductive animals, for the user and on its efficacy as an emulsifier. The applicant provided new data to support the absence of genotoxicity for guar gum, and two tolerance studies, one in dogs and one in cats. The Panel concluded that guar gum does not raise concerns for genotoxicity and that guar gum is considered safe for all animal species at the respective proposed maximum safe concentration in complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10241"},"PeriodicalIF":3.8,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13418618/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618787","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 genetically modified soybean DAS-44406 × FG72 (dossier GMFF-2025-34192).","authors":"Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud de Maagd, Michelle M Epstein, Thomas Frenzel, Jean-Luc Gallois, Frits Koning, Antoine Messéan, F Javier Moreno, Fabien Nogué, Giovanni Savoini, Alan H Schulman, Christoph Tebbe, Eve Veromann, Michele Ardizzone, Giacomo De Sanctis, Antonio Fernandez Dumont, Arianna Ferrari, Andrea Gennaro, José Ángel Gómez Ruiz, Tilemachos Goumperis, Sara Jacchia, Dafni Maria Kagkli, Paolo Lenzi, Ana M Camargo, Franco Maria Neri, Tommaso Raffaello","doi":"10.2903/j.efsa.2026.10268","DOIUrl":"10.2903/j.efsa.2026.10268","url":null,"abstract":"<p><p>Genetically modified soybean DAS-44406-6 × FG72 was developed by conventional crossing to combine two single events: DAS-44406-6 and FG72. The soybean DAS-44406-6 × FG72 expresses the AAD-12, 2mEPSPS, PAT and HPPD W336 proteins to confer herbicide tolerance to 2,4-D-, glyphosate-, glufosinate-containing and HPPD-inhibiting herbicide products, respectively. The GMO Panel previously assessed the two single soybean events and did not identify safety concerns. No new data on the single soybean events were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the soybean DAS-44406-6 × FG72 does not give rise to food and feed safety or nutritional concerns. The GMO Panel concludes that the DAS-44406-6 × FG72 stack soybean, as described in this application, is as safe as the non-GM comparator and non-GM reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of release of processed soybean DAS-44406-6 × FG72 or accidental spillage of viable GM soybean seeds into the environment, this would not raise environmental safety concerns. The post market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS-44406-6 × FG72. The GMO Panel concludes that soybean DAS-44406-6 × FG72 is as safe as its non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10268"},"PeriodicalIF":3.8,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13417728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618857","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":"Scientific Opinion on waiving of the dog studies in the regulatory process of agrochemicals approval.","authors":"Tamara Coja, Pauline Adriaanse, Antonio Finizio, Maeva Giraudo, Thomas Kuhl, Emily McVey, Francesca Metruccio, Martin Paparella, Silvia Pieper, Eugenio Scanziani, Ivana Teodorovic, Paul Van der Brink, Martin Wilks, Antonio Hernandez-Jerez, Olavi Pelkonen, Andrea Terron, Jochem Louisse, Martina Panzarea, Adriana Scattareggia Marchese, Judy Choi","doi":"10.2903/j.efsa.2026.10239","DOIUrl":"10.2903/j.efsa.2026.10239","url":null,"abstract":"<p><p>Commission Regulation (EU) No. 283/2013 sets out the data requirements for pesticide active substances and includes short-term oral toxicity testing in rodents (90-day rat study) and non-rodents (90-day dog study) to support human health hazard assessment for pesticide active substances in the European Union (EU). However, the relevance of the 90-day dog study for such assessments has been increasingly questioned. In this context, the EFSA Panel on Plant Protection Products and their Residues (PPR Panel) initiated a self-task mandate to evaluate the contribution of the 90-day dog study to hazard assessment and to explore whether dog studies may be waived from a scientific perspective. This work included a retrospective analysis for the role of dog data in the derivation of health-based guidance values (HBGVs, i.e. acceptable daily intake (ADI) and acceptable operator exposure level (AOEL)) for pesticide active substances in the EU and the development of a tiered assessment strategy to support regulatory decision-making for new active substances. The evidence obtained in the retrospective analysis showed that, in 97% of the cases for ADI and 95% for AOEL, observed interspecies differences in established no observed adverse effect levels (NOAELs) were attributable to experimental and biological variability, differences in study design and/or allometric scaling, rather than reflecting a genuine dog-specific sensitivity. Further analyses of modes of action (MoA); absorption, distribution, metabolism and excretion (ADME); and toxicokinetic (TK) profiles across species were conducted. Based on the retrospective analysis, a tiered assessment strategy was defined to decide whether for a new active substance, the 90-day dog study can be waived. A minimum data set and scientific criteria were defined for this assessment strategy, which includes integration of physiologically based kinetic (PBK) modelling and human-relevant data. The PPR Panel concludes that this strategy provides a robust basis to support the waiving of dog studies when scientifically justified and supports the implementation of new approach methodologies (NAMs) in the regulatory risk assessment of pesticide active substances.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10239"},"PeriodicalIF":3.8,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13417730/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618809","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 of <i>Anaerobutyricum soehngenii</i>CH106 as a novel food pursuant to Regulation (EU) 2015/2283.","authors":"Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesca Marcon, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Reinhard Ackerl, Maria Glymenaki, Thomas Frenzel","doi":"10.2903/j.efsa.2026.10255","DOIUrl":"10.2903/j.efsa.2026.10255","url":null,"abstract":"<p><p>Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of freeze-dried viable <i>Anaerobutyricum (A.) soehngenii</i> CH106 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant intends to market the NF in food supplements for adults at a maximum dose of 2.0 × 10⁹ active fluorescent units (AFU)/day, corresponding to 2.9 × 10⁷ AFU/kg body weight per day. The information on the identity, production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. There are no concerns regarding genotoxicity of the NF. A human intervention study with the NF, in which half of the proposed dose was given to the participants for 3 months, did not reveal any safety concerns. One 90-day oral toxicity study in Wistar rats was provided from which the Panel identified the highest dose tested in males, i.e. 4.7 × 10¹⁰ AFU/kg bw per day, as the NOAEL. The margin of exposure between the NOAEL and the maximum proposed daily dose of the NF is 1621, which the Panel considers to be sufficient. Considering that appropriate initial bacteria colonisation of the gastrointestinal tract in humans profoundly affects health during infancy and childhood, that little is known on how the maternal microbiota shapes the maternal-fetal immune system during pregnancy and that disruptions to the gut microbiota early in life can have lasting health effects into adulthood, the Panel considers that pregnant and lactating women should be excluded from the target population. The Panel concludes that the NF, freeze-dried viable <i>A. soehngenii</i> CH106, is safe at 2.0 × 10⁹ AFU/day for the general adult population, excluding pregnant and lactating women.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10255"},"PeriodicalIF":3.8,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13409035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618796","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 l-leucine produced with <i>Corynebacterium glutamicum</i>KCCM 80421 for all animal species (CJ Europe GmbH).","authors":"Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Giovanna Martelli, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Katerina Theodoridou, Paul Brantom, Luca Tosti, Montserrat Anguita, Matteo L Innocenti, Maria Kolona, Fabiola Pizzo, Jordi Tarrés-Call","doi":"10.2903/j.efsa.2026.10249","DOIUrl":"10.2903/j.efsa.2026.10249","url":null,"abstract":"<p><p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-leucine produced with a genetically modified strain of <i>Corynebacterium glutamicum</i> (KCCM 80421) when used as nutritional (amino acid) and/or sensory (flavouring compound) feed additive in feed and water for drinking for all animal species and categories. The l-leucine manufactured by fermentation with <i>C. glutamicum</i> KCCM 80421 did not give rise to any safety concern regarding the genetic modifications of the production strain. No viable cells nor DNA of the production strain were detected in the final product. The use of l-leucine produced with <i>C. glutamicum</i> KCCM 80421 in feed was considered safe for the target species when used as amino acid to supplement in appropriate amounts the diet, according to the nutritional needs of the target species; or when used as a flavouring compound. The FEEDAP Panel had concerns on the use of l-leucine in water for drinking. The use of l-leucine produced by fermentation with <i>C. glutamicum</i> KCCM 80421 in animal nutrition as amino acid or a flavouring compound was considered safe for the consumers of products from animals receiving the additive and for the environment. Regarding the user safety, the additive was not considered irritant to skin or eyes and was not considered a potential skin sensitiser. The additive was regarded as an effective source of the amino acid l-leucine for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation. l-Leucine was considered efficacious when used as a flavouring compound in animal nutrition.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10249"},"PeriodicalIF":3.8,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13409038/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618789","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":"Literature horizon scan for new scientific data on plants, microorganisms and animals, and their products obtained by new genomic techniques (March 2026).","authors":"Michele Ardizzone, Fulvio Barizzone, Martina Bonatti, Alice Branchi, Tilemachos Goumperis, Dafni Maria Kagkli, Paolo Lenzi, Aleksandra Lewandowska, Ana M Camargo, Irene Pilar Munoz Guajardo, Nikoletta Papadopoulou, Tommaso Raffaello","doi":"10.2903/j.efsa.2026.10230","DOIUrl":"10.2903/j.efsa.2026.10230","url":null,"abstract":"<p><p>The European Food Safety Authority has issued several scientific opinions on plants, microorganisms and animals obtained through certain new genomic techniques (NGTs), following requests received by the European Commission. These scientific opinions provided considerations on the potential risks associated with NGTs, as compared to conventional breeding techniques and established genomic techniques (EGTs), and on the applicability of existing guidelines for the risk assessment of plants, microorganisms and animals obtained by NGTs and products thereof. Against this background, EFSA was asked by the European Commission 'to provide scientific and technical assistance for a regular horizon scanning to assess new scientific data on plants, microorganisms and animals, and products thereof obtained by new genomic techniques', to assess any new data and evidence emerging from these studies, and to consider whether it may have implications for EFSA's relevant scientific opinions. A critical assessment of the quality and relevance of these studies should also be conducted, and biannual reports delivered to the Commission. This report presents the outcome of the literature search on new scientific data on plants, microorganisms and animals and products thereof obtained by NGTs, performed as described in the protocol made available for public consultation in May-June 2025. The report describes search strategies and inclusion/exclusion criteria applied for literature review and presents the results of the assessment performed for new scientific data (published up to March 2026) on plants, microorganisms and animals and products thereof obtained by NGTs. The report discusses the limitations of the search and provides recommendations for improvement. EFSA concluded that none of the studies retrieved by the literature search contained new hazards or risks not previously considered in EFSA scientific opinions.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10230"},"PeriodicalIF":3.8,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13409037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618791","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":"Update of the risk assessment on emerging and novel brominated flame retardants in food.","authors":"Helle Katrine Knutsen, Agneta Åkesson, Vasileios Bampidis, Margherita Bignami, Laurent Bodin, James Kevin Chipman, Gisela Degen, Antonio Hernández-Jerez, Tim Hofer, Christer Hogstrand, Stefano Landi, Jean-Charles Leblanc, Kyriaki Machera, Evangelia Ntzani, Isabelle P Oswald, Guido Rychen, Salomon Sand, Katharina Vejdovszky, Barbara Viviani, Emilio Benfenati, Diane Benford, Andy Hart, Martin Rose, Henri Schroeder, Christiane Vleminckx, Martine Vrijheid, Edoardo Carnesecchi, Violetta Costanzo, Andrea Gissi, Eirini Kouloura, Luisa Ramos Bordajandi, Francesca Riolo, Christer Hogstrand","doi":"10.2903/j.efsa.2026.10187","DOIUrl":"10.2903/j.efsa.2026.10187","url":null,"abstract":"<p><p>The European Commission asked EFSA to update its 2012 risk assessment on Emerging and Novel brominated flame retardants (BFRs) in food. Since the previous Opinion, further information was collected for a total of 27 BFRs. The CONTAM Panel concluded that <b>TDBPP</b>, <b>DBPNG</b> and <b>TBNPA</b> are considered genotoxic and carcinogenic. Based on positive in vitro mutagenicity in mammalian cells, <b>DBE-DBCH</b> is considered genotoxic. <b>EBTEBPI</b>, <b>DBDPE</b>, <b>PBB-Acr</b> and <b>TTBP-TAZ</b> are not genotoxic. Insufficient or absent data precluded the Panel to conclude on the genotoxic potential of the remaining BFRs. Reproductive/developmental toxicity and/or neurotoxicity/neurodevelopmental effects were reported for <b>DBNPG</b>, <b>BEH-TEBP</b>, <b>EH-TBB</b>, <b>DBDPE</b> and <b>TDBP-TAZTO</b>. Reference Points were identified for <b>TDBPP</b>, <b>DBNPG</b>, <b>BEH-TEBP</b>, <b>EH-TBB</b>, <b>DBDPE</b> and <b>TDBP-TAZTO</b>. No health-based guidance values could be derived for any of the BFRs. Occurrence data were submitted to EFSA for eight BFRs (<b>BEH-TEBP</b>, <b>EH-TBB</b>, <b>BTBPE</b>, <b>DBDPE</b>, <b>HBB</b>, <b>PBEB</b>, <b>PBT</b>, <b>TBX</b>). Dietary exposure could be estimated only for <b>BTBPE</b> and <b>HBB</b>, due to the lack of quantitative data for the other BFRs. However, no risk characterisation could be performed for these BFRs due to the lack of a Reference Point. Using the limited available information on dietary exposure estimates reported in the scientific literature, risk characterisation could be performed for <b>BEH-TEBP</b>, <b>EH-TBB</b> and <b>DBDPE</b>, and the CONTAM Panel concluded that dietary exposure does not raise a health concern. The Panel considered that the level of certainty was 90% or higher for most of the reported conclusions. Very limited or no information on hazard or exposure were available for <b>HBCYD</b>, <b>TBCO</b>, <b>DBHCTD</b>, <b>HCTBPH</b>, <b>BDBP</b>-<b>TAZTO</b>, <b>DBP</b>-<b>TAZTO</b>, <b>OBTMPI</b>, <b>DBS</b>, <b>HEEHP-TEBP</b>, <b>4'-PeBPO-BDE208</b> or <b>TTBNPP</b>. Recommendations were formulated to address data gaps, including the need for access to original data, and for the collection of biomonitoring data, occurrence data in food, genotoxicity information and toxicological studies to support the identification of a Reference Point.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10187"},"PeriodicalIF":3.8,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13403159/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148600609","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":"Setting of import tolerance for folpet in bananas and modification of the existing maximum residue level in honey.","authors":"Giulia Bellisai, Giovanni Bernasconi, Irene Castellan, Monica Del Aguila, Lucien Ferreira, Renata Leuschner, Andrea Mioč, Marta Szot, Manuela Tiramani, Alessia Verani","doi":"10.2903/j.efsa.2026.10168","DOIUrl":"10.2903/j.efsa.2026.10168","url":null,"abstract":"<p><p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV submitted a request to the competent national authority in Austria to set an import tolerance for the active substance folpet in bananas. Within the submitted application the applicant requested as well to modify the existing maximum residue level (MRL) for folpet in honey. The data submitted in support of the requests were found to be sufficient to derive an MRL proposal for bananas according to the current residue definition for enforcement. For honey however, the submitted trials were not compliant with good agricultural practice (GAP) and therefore not appropriate to derive an MRL proposal. Adequate analytical methods for enforcement, based on liquid and gas chromatography, are available to quantify residues of folpet and phthalimide in bananas and honey with lowest validated limit of quantification (LOQ) of 0.01 mg/kg (both compounds). Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of folpet residues expected in bananas and honey is unlikely to present a risk to consumer health. However, uncertainties remain regarding the long-term exposure assessment due to missing residue data for phthalamic acid (in root crops) and phthalic acid (in all commodities except bananas and honey).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10168"},"PeriodicalIF":3.8,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13403157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148600538","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":"Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005.","authors":"","doi":"10.2903/j.efsa.2026.10269","DOIUrl":"10.2903/j.efsa.2026.10269","url":null,"abstract":"<p><p>Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) shall provide within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide by 1 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC before 2 September 2008. Among the active substances subject to review under Article 12(1) or Article 12(2) of Regulation (EC) No 396/2005, EFSA identified three active substances for which a review of MRLs is no longer considered necessary. This includes two substances that were temporarily listed in Annex IV of Regulation (EC) No 396/2005 by risk managers pending finalisation of their evaluation under Directive 91/414/EEC or Regulation (EC) No 1107/2009 as well as the publication of EFSA's reasoned opinion in accordance with Article 12 of Regulation (EC) No 396/2005. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 7","pages":"e10269"},"PeriodicalIF":3.8,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13404005/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148600576","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}