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- Safety assessment of the process EREMA Vacurema Basic_Sheet used to recycle post‐consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials (FCM); Lambré, Claude; Crebelli, Riccardo; Silva, Maria da; Grob, Koni; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; Tavares Poças, Maria de Fátima; Marano, Remigio; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process EREMA Vacurema Basic_Sheet (EU register number RECYC 337). The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with below 5% PET from non‐food consumer applications. The flakes are heated in a continuous flake reactor (step 2) under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the step 2 is critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency are the temperature, the pressure (vacuum) and the residence time. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.156 or 0.312 μg/kg food, depending on the molar mass of the contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with foodstuffs, excluding drinking water, reconstituted infant formula and human milk, and used for long‐term storage at room temperature or below, with or without hot‐fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.
- Safety assessment of the process brtCOMBIPET used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Koni; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; Tavares Poças, Maria de Fátima; Lioupis, Alexandros; Tsochatzis, Emmanouil; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process brtCOMBIPET (EU register number RECYC338). The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried (step 6), melted in an extruder (step 7) and pelletised, dried and crystallised (step 8). The pellets are then preheated, further crystallised, then decontaminated in a solid‐state polymerisation (SSP) reactor (step 9) and cooled down. Having examined the challenge tests provided, the Panel concluded that the extrusion, the preheating and the SSP are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance are the temperature and the pressure for step 7 (extrusion) as well as the temperature, residence time and gas flow rate for step 9 (preheating and SSP). It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of the contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hot‐fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.
- Iron metabolism genes shape the course of liver fibrosis in chronic hepatitis C: from disease progression to reversal after direct-acting antivirals treatmentPublication . Ferreira, Joana; Bicho, Manuel; Faustino, Paula; Serejo, FátimaChronic hepatitis C (CHC) is linked to iron overload, which significantly correlates with liver fibrosis. This study aimed to assess whether genetic polymorphisms related to iron metabolism are associated with fibrosis severity, predict improvement in fibrosis after HCV clearance with direct-acting antivirals (DAAs) and influence iron-related metabolic markers before treatment. A total of 329 CHC patients were included, 134 of whom received DAAs therapy. Liver fibrosis was assessed using transient elastography (FibroScan), and biochemical parameters were measured using standard methods. Eighteen genetic polymorphisms within five iron metabolism-related genes were analyzed using PCR-RFLP, endpoint genotyping, or next-generation sequencing (NGS). Before DAA treatment, patients with severe f ibrosis showed higher levels of serum iron (Fe), total iron-binding capacity (TIBC), and ferritin (Ft). SLC40A1 rs1439816_GG was associated with an increased risk of severe fibrosis. compared with GC or CC genotypes. SLC40A1 rs11568351_GC genotype was linked to a higher likelihood of remaining cirrhotic after HCV clearance. Elevated iron parameters were observed in carriers HFE C282Y_CY, TF IVS 11 G>A, and BMP2 570 A>T. Overall, polymorphisms in iron metabolism genes may influence both the severity of liver fibrosis prior to treatment, its regression after DAA therapy and the regulation of iron metabolism in CHC patients.
- Prevalence of abdominal obesity in the Portuguese population assessed by different anthropometric indicesPublication . Santos, Maria; Sousa-Uva, Mafalda; Namorado, Sónia; Gonçalves, Teresa; Dias, Carlos Matias; Gaio, VâniaIntroduction: Cardiovascular diseases are the leading cause of death globally. The association between abdominal obesity and cardiovascular risk is well established. This study aimed to estimate and characterize the prevalence of abdominal obesity in the Portuguese population aged 25–74 years in 2015, using waist circumference, waist to- hip ratio, waist-to-height ratio, and a body shape index. Methods: Data from the First National Health Examination Survey, a cross-sectional study, was used. Participants aged between 25 and 74 years, not pregnant, and with available data on anthropometric measurements (weight, height, waist circumference, and hip circumference) were included. Individuals undergoing cancer treatment were excluded from the study. Results: Among 4812 participants the prevalence of abdominal obesity according to each considered anthropometric measure was 40.3 % (95 % CI: 38.0–42.5), 43.6 % (95 % CI: 40.1–47.0), 65.2 % (95 % CI: 62.8–67.5) and 75.5 % (95 % CI: 74.1–76.9) when considering waist circumference, a body shape index, waist-to-hip ratio and waist-to-height ratio, respectively. The most affected individuals had 60–74 years, with no formal education or only primary education and engaged in low-skilled occupations (e.g., farmers, industrial workers, and construction workers). These findings remained consistent, regardless of the index under consideration. Conclusion: The prevalence of abdominal obesity ranged from 40.3 % for waist circumference to 75.5 % for waist-to-height ratio. Nonetheless, irrespective of the index employed, the prevalence was elevated. Older individuals, with lower education levels, and those engaged in less skilled occupations were most affected. Early identification of abdominal obesity in Primary Healthcare is essential.
- Effectiveness of long-acting monoclonal antibodies against laboratory-confirmed RSV in children aged < 24 months and hospitalised for severe acute respiratory infection, European pilot study, 2024 to 2025Publication . Savulescu, Camelia; Ganser, Iris; Nicolay, Nathalie; Lajot, Adrien; Campos, Sandra; Martínez-Baz, Iván; Rodrigues, Ana Paula; Vandromme, Mathil; Cara-Rodríguez, Marta; Echeverría, Aitziber; Gaio, Vânia; Parsy, Marie-Pierre; Garrido, Ana Roldan; Castilla, Jesús; Guiomar, Raquel; Bacci, Sabrina; Rose, Angela Mc; VEBIS hospital network RSV IE groupWe measured effectiveness of nirsevimab against laboratory-confirmed respiratory syncytial virus (RSV) infection in a test-negative case-control study among children aged < 24 months hospitalised for severe acute respiratory infection in three European countries. The overall effectiveness in the 2024/25 season among 2,201 children was 79% (95% CI: 58 to 89) and 85%, 78% and 69% at < 30, 30-89 and 90-215 days since immunisation. Immunisation was effective for preventing RSV-related hospitalisation in children, but effectiveness by time since immunisation needs monitoring in future seasons.
- From Food to Humans: The Toxicological Effects of Alternaria Mycotoxins in the Liver and ColonPublication . Vilela, Rita Sofia; Pina-Martins, Francisco; Ventura, CéliaAlternaria mycotoxins represent a significant and emerging concern in the field of food safety due to their widespread occurrence in diverse food and feed commodities, including cereals, tomatoes, oilseeds, and dried fruits. Among these, alternariol (AOH), alternariol monomethyl ether (AME), tenuazonic acid (TeA), and altertoxin-I (ATX-I) are the most frequently detected, often co-occurring at varying concentrations, thereby increasing the complexity of exposure and risk assessment. The gastrointestinal tract (GIT) is a crucial target of these toxins, as well as the liver, particularly considering its detoxifying role. Nevertheless, despite being a source of possible gastrointestinal and hepatic toxicity, there is still scarce data on the toxicokinetics of Alternaria toxins, on their mode of action, and respective toxic effects. To date, in vitro studies have shown that different Alternaria mycotoxins exhibit diverse toxicological effects, which may be dependent on their chemical structure. AOH and ATX-I have shown genotoxicity and cytotoxicity, mainly through interaction with the DNA and apoptosis, respectively. Tentoxin (TEN) has displayed hepatotoxic potential via impairment of detoxification pathways, and altenuene (ALT) has revealed lower toxicity. In vivo, AME and ATX-II revealed genotoxicity, while AOH and ATX-I showed context-dependent variability in their effects. Altogether, this review emphasizes that there is still a great lack of knowledge on these mycotoxins and an urgent need for more comprehensive toxicological and occurrence data to support proper risk assessment and, ultimately, regulatory decision-making.
- FAIREHR: a novel online research registry platform to advance global environmental and occupational health researchPublication . Galea, Karen S.; Brooker, Finlay; Rashid, Shahzad; Bader, Michael; Ait Bamai, Yu; Bessems, Jos; Beyene, Embialle Mengistie; Connolly, Alison; Costa, Carla; Deligannu, Pravina; Duca, Radu-Corneliu; Chbihi, Kaoutar; Eba, Kasahun; Ghosh, Manosij; Gonzales, Melissa; Harrad, Stuart; Haynes, Erin N.; Hopf, Nancy B.; Huang, Po-Chin; Jones, Kate; Kasiotis, Konstantinos M.; Chung, Ming Kei; Kil, Jihyon; Koch, Holger; Kwon, Jung-Hwan; Lin, Elizabeth Ziying; Louro, Henriqueta; Machera, Kyriaki; Magagna, Barbara; Menouni, Aziza; Mizuno, Yuki; Van Nieuwenhuyse, An; Nakayama, Shoji F.; Robert Pasanen-Kase; Pollock, Tyler; Quirós-Alcalá, Lesliam; Santonen, Tiina; Scheepers, Paul J.; Sepai, Ovnair; Bird, Emily; Serrano Ramòn, Blanca; Silva, Maria Joao; Souza, Gustavo; Stingone, Jeanette A.; Teitelbaum, L. Susan; Teixeira, João Paulo; Tranfo, Giovanna; Vekic, Ana Maria; Viegas, Susana; Xia, Yankai; Yunesian, Masud; Zare Jeddi, MaryamThe FAIREHR (Findable, Accessible, Interoperable, Reusable Environmental and Health Registry) platform is a state-of-the-art online registry for prospective harmonization of human biomonitoring (HBM). It was developed by the HBM working group of the Europe Regional Chapter of the International Society of Exposure Science (ISES Europe) and is supported by the HBM Global Network. FAIREHR is designed to harmonize HBM metadata and support the implementation of the FAIR (Findable, Accessible, Interoperable and Reusable) Guiding Principles throughout HBM studies or programs. The registry enables preregistration of HBM by capturing key metadata on study design, metadata management, and planned methods before participant recruitment. This process enhances transparency and reproducibility in environmental and occupational health research. FAIREHR includes both study-level and program-level metadata. Its harmonized metadata template facilitates the storage of results (measurement data) in repositories such as IPCHEM and PEH. Here we outline the unique features of the FAIREHR platform, emphasizing its role in increasing research visibility, improving metadata comparability and harmonization, and strengthening the exchange of information. By supporting the effective use of HBM data, FAIREHR is expected to yield significant benefits for researchers, policymakers, and the broader fields of environmental and occupational health.
- Scientific opinion as regards the specifications of the food additives acetic, lactic, tartaric, mono- and diacetyltartaric, mixed acetic and tartaric acids esters of mono- and diglycerides of fatty acids (E 472a,b,d,e,f)Publication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Passamonti, Sabina; Fürst, Peter; Karlien, Cheyns; Mirat, Manuela; Tard, Alexandra; Rincon, Ana MariaAcetic, lactic, tartaric, mono- and diacetyltartaric, mixed acetic and tartaric acids esters of mono- and diglycerides of fatty acids (E 472a,b,d,e,f) were re-evaluated in 2020 by the Food Additives and Flavourings (FAF) Panel. The Panel issued several recommendations to amend the specifications of these food additives in Commission Regulation (EU) No 231/2012. The present opinion deals with the assessment of the data provided by interested business operators (IBOs) in support of an amendment of the EU specifications for these food additives. It also includes an assessment of dietary exposure to E 472d, E 472e and E 472f. The Panel concluded that the technical data provided by an IBO support amendments to the specifications for E 472a, E 472b and E 472e in Commission Regulation (EU) No 231/2012. However, regarding E 472d and E 472f, the Panel was unable to confirm that technical data provided by IBOs adequately support an amendment of the specifications as no supporting technical data were provided for these food additives. Dietary exposure estimates for E 472d, E 472e and E 472f, across all population groups and exposure scenarios, were found to be below the acceptable daily intake (ADI) of 480 mg/kg body weight (bw) per day for E 472d and 600 mg/kg bw per day for E 472e and E 472f, based on the food categories included in the assessment.
- Re‐assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materialsPublication . EFSA Panel on Food Contact Materials (FCM); Claude, Lambré; Crebelli, Riccardo; Silva, Maria Da; Grob, Konrad; Lampi, Evgenia; Milana, Maria Rosaria; Pronk, Marja; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Bolognesi, Claudia; Consiglio, Emma Di; Mengelers, Marcel; Al Harraq, Zainab; Pilar, Irene Muñoz; Rainieri, Sandra; Rivière, GillesThe EFSA Panel on Food Contact Materials (FCM) was requested by the European Commission to re‐evaluate the potential genotoxicity of styrene after oral exposure and its safety for use in plastic FCM with a specific migration limit (SML) of 40 μg/kg food. A rigorous assessment of the in vivo genotoxicity studies (i) provided by third parties, (ii) identified by a targeted literature search and (iii) reported in the 2019 IARC Monograph was performed. All studies were assessed for reliability and relevance and the results integrated in the weight of evidence. The results provided by reliable in vivo oral genotoxicity studies, covering different genetic endpoints and target tissues, including liver, the primary site of metabolism, demonstrated that the oral administration of styrene in mice and rats up to the maximum tolerated dose (300 and 500 mg/kg body weight (bw), respectively) did not induce genotoxic effects. The Panel concluded that there was no evidence that styrene is genotoxic following oral exposure. For substances demonstrated to be non‐genotoxic, according to the EFSA Note for Guidance for FCM, an SML up to 50 μg/kg food would not be of safety concern. Consequently, the use of styrene in the manufacture of FCM respecting the SML of 40 μg/kg food proposed by the European Commission is not of safety concern.
- Safety assessment of the substance N,N′‐(2‐(4‐(2‐aminobenzamido)butyl)pentane‐1,5‐diyl)bis(2‐aminobenzamide) for use in plastic food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Konrad; Lampi, Evgenia; Milana, Maria Rosaria; Pronk, Marja; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Cariou, Ronan; Castle, Laurence; Di Consiglio, Emma; Franz, Roland; Barthélémy, Eric; Marano, Remigio; Rivière, GillesThe EFSA Panel on Food Contact Materials assessed the safety of N,N′‐(2‐(4‐(2‐aminobenzamido)butyl)pentane‐1,5‐diyl)bis(2‐aminobenzamide) to be used at up to 650 mg/kg in polyethylene terephthalate (PET) to scavenge acetaldehyde (AA). Final articles are intended for contact with aqueous, acidic and low‐alcoholic beverages for long‐term storage at room temperature and below. The migration of the substance from PET bottles into 20% ethanol was 0.0038 mg/kg food. The Panel calculated the potential migration of the summed reaction products not to exceed 0.02 mg/kg food. From experimental studies, the Panel excluded genotoxicity concerns for the substance, for 2‐aminobenzamide +1 formaldehyde and 2‐aminobenzamide +1 AA, both with desaturation. In silico predictions, previous EFSA evaluations and the use of the threshold of toxicological concern (TTC) excluded genotoxicity concerns for 15 other impurities/reaction products. A tentatively identified by‐product was predicted as possible DNA‐reactive in vitro mutagen and clastogen, due to its aromatic hydroxylamine group. Its modelled migration would not exceed 0.14 μg/kg food, leading to a potential exposure below the TTC of 0.0025 μg/kg body weight per day. Non‐identified reaction products are expected to be structurally related to the identified ones and, hence, not to raise concern for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer, if it is used as an additive at up to 650 mg/kg in PET intended for contact with foods simulated by simulants A, B and C, for storage above 6 months at room temperature and below, including hot‐fill conditions and/or heating up to 70°C ≤ T ≤ 100°C for maximum t = 120/2((T−70)/10) minutes. The substance should not be used for infant formula (including water used for reconstitution) and human milk. The migration of the substance should not exceed 0.05 mg/kg food. The substance should not contain aromatic hydroxylamine derivatives at more than 0.15% w/w.