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- Scientific opinion on the amendment of the specifications for vegetable carbon (E 153) as a food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Furst, Peter; Gaffet, Eric; Loeschner, Katrin; Mast, Jan; Mirat, Manuela; Oomen, Agnes; Undas, Anna; Mech, Agnieszka; Smeraldi, Camilla; Rincon, Ana MariaThe food additive vegetable carbon (E 153) was re‐evaluated by the EFSA ANS Panel in 2012. During that re‐evaluation, data gaps were identified, in particular with respect to impurities and particle characterisation. Following a European Commission call for data to address these gaps, one interested business operator (IBO) submitted analytical data on toxic elements, polycyclic aromatic hydrocarbons (PAHs) and particle size distribution of commercial samples of E 153. The present opinion deals with the assessment of the data provided by the IBO in response to the European Commission call. Based on the analytical data provided, the Panel concluded that the information on toxic elements supports a revision of the current EU specification limits for arsenic, cadmium, mercury and lead, and the introduction of a limit for aluminium. Regarding PAHs, the Panel assessed the risks associated with benzo[a]pyrene and PAH4 under several scenarios and concluded that the resulting margins of exposure (MOE) were above the level of concern but recommended lowering the current limit for benzo[a]pyrene and introducing a limit for PAH4 in the EU specifications for E 153. For what concerns the data on particle size distribution and morphology, the Panel considered that, due to methodological limitations, these data did not allow a full characterisation of the materials used as a food additive and did not adequately support an amendment of the specifications in relation to particle properties. Nevertheless, the Panel concluded that a fraction of small particles, including nanoparticles, is present in vegetable carbon (E 153) and noted that the substance is insoluble in water. Therefore, in line with the EFSA Guidance on Particles‐TR, the Panel concluded that the risk assessment of E 153 performed by the EFSA ANS Panel in 2012 should be complemented with nanoscale considerations.
- Attainment of global diabetes targets in 2021: a pooled analysis of individual-level data from national surveys in 100 low-income, middle-income, and high-income countriesPublication . Global Health and Population Project on Access to Care for Cardiometabolic Diseases CollaboratorsBackground: WHO launched the Global Diabetes Compact in 2021 to improve worldwide diabetes outcomes by scaling up access to comprehensive, affordable, and high-quality care. This initiative established population diabetes metrics and targets for countries to attain by 2030, namely, 80% of all people with diabetes are diagnosed; and, among people with diagnosed diabetes, 80% have good glycaemic control (HbA1c <8·0%), 80% have good blood pressure control (<140/90 mm Hg), and 60% of people older than 40 years use statins. We aimed to estimate attainment of global diabetes targets worldwide and across country and individual characteristics in 2021. Methods: We analysed pooled, individual participant data from nationally representative household health surveys done in 100 low-income, middle-income, and high-income countries between 2010 and 2023. The sample included non-pregnant adults aged 30-69 years. Diabetes was defined as use of glucose-lowering medications or biochemical evidence of diabetes (fasting plasma glucose ≥7·0 mmol/L or HbA1c ≥6·5% [48 mmol/mol]). The primary outcomes were the proportion of people attaining each diabetes metric. We analysed data using hierarchical Bayesian logistic regression models with the survey year set to 2021. We estimated the age-standardised proportion attaining each metric across the pooled dataset, by country-level characteristics such as World Bank income group, by country, and by individual-level characteristics including age, sex, educational attainment, and BMI. Findings: In 2021, across the pooled dataset, the age-standardised proportion of people with diabetes who had been diagnosed was 63·2% (95% CI 61·8-64·6). Among those diagnosed, 63·2% (62·1-64·4) achieved glycaemic control (HbA1c <8·0%), 70·8% (69·8-71·9) achieved blood pressure control (<140/90 mm Hg), and 31·8% (30·4-33·2) were using statins. Of the 100 included countries, eight met the target for diabetes diagnosis, seven met the target for glycaemic control, 15 met the target for blood pressure control, and eight met the target for statin use. By country income group, the age-standardised proportion of people with diabetes who had been diagnosed ranged from 35·3% (33·5-37·1) in low-income countries to 69·9% (68·3-71·5) in high-income countries. Among those with diagnosed diabetes, glycaemic control ranged from 56·0% (54·2-57·8) in lower-middle-income countries to 73·7% (72·7-74·6) in high-income countries; blood pressure control ranged from 58·3% (57·3-59·4) in lower-middle-income countries to 82·4% (81·4-83·4) in high-income countries; and statin use ranged from 9·7% (8·0-11·4) in low-income countries to 58·7% (57·4-59·9) in high-income countries. Across individual-level characteristics, patterns of inequities were observed in the attainment of each metric. Interpretation: There are pronounced inequities at multiple levels in the attainment of global diabetes metrics. Substantial progress is needed to reduce inequities and to achieve the 2030 targets.
- Safety evaluation of the modification of the food additive enzymatically produced steviol glycosides (E 960c)Publication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Herman, Lieve; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Civitella, Consuelo; Dino, Borana; Lunardi, Simone; Mech, Agnieszka; Multari, Samuele; Ruggeri, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a modified manufacturing process for the food additive enzymatically produced steviol glycosides (E 960c). The new process converts purified steviol glycosides extracted from Stevia rebaudiana leaves through enzymatic bioconversion catalysed by glucosyltransferase and sucrose synthase enzymes, both produced using three newly developed genetically modified strains of Escherichia coli (CDX‐044 W3110‐TKO, CDX‐045 W3110‐TKO and CDX‐047 W3110‐TKO). This modification of the manufacturing process yields two distinct preparations of steviol glycosides: SBP1, composed predominantly of rebaudioside M, and SBP2, composed predominantly of rebaudioside D. The modification leads to changes in the definition of the food additive, residual protein, residual solvents, microbiological criteria and particle size. The Panel concurred with the applicant's proposal to introduce two new entries in Commission Regulation (EU) No. 231/2012 corresponding to SBP1, predominantly rebaudioside M, and SBP2, predominantly rebaudioside D. The manufacturing process does not raise a safety concern since no viable cells nor DNA of the production strains remained in the final product; in addition, the food enzyme–total organic solid (TOS) are removed to at least 99%, and consequently, the exposure to the food enzyme–TOS via consumption of SPB1 and SPB2 can be considered negligible. The Panel considered that rebaudioside M and D produced by this new manufacturing process have the same physicochemical characteristics as the corresponding rebaudioside M and D present in E 960c(i), (ii) and (iii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of SBP1 and SBP2. The Panel concluded that there is no safety concern with respect to the proposed modification of the food additive enzymatically produced steviol glycoside E 960c related to the use of the new genetically modified strains of E. coli in the production process of SBP1 and SBP2.
- Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008Publication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernandez, Maria Jose; Gundert-Remy, Ursula; Ursula Gundert‐Remy; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barmaz, Stefania; Carfì, Maria; Civitella, Consuelo; Gagliardi, Gabriele; Lodi, Federica; Martino, Carla; Mazzoli, Elena; Mech, Agnieszka; Rasinger, Josef Daniel; Rincon, Ana Maria; Ruggeri, Laura; Smeraldi, Camilla; Tard, Alexandra; Zakidou, PanagiotaThis guidance document applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food additive, submitted under Regulation (EC) No 1333/2008. It defines the scientific data required to evaluate if the food additive is safe under the proposed conditions of use, in accordance with Articles 1 and 6 of Regulation (EC) No 1333/2008. The data requirements pertain to the characterisation of the proposed food additive, including the description of its identity, manufacturing process, specifications, stability, reaction and fate in foods and methods of analysis in food; the proposed uses and use levels and the dietary exposure; the safety data, including information on the genotoxic potential of the food additive, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should provide data in accordance with this guidance document to support the safety assessment of the proposed food additive. Based on the submitted data, EFSA will assess the safety of the food additive in line with the risk assessment principles described in this document and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.
- Autoencoder/RandomForest-TabPFN for cross-cancer metabolomics: prostate and breast cancer diagnosis using paper spray and ion mobility-mass spectrometry techniquesPublication . Hauns, Sven; Pinto, Frederico G.; Khyriem, Costerwell; Singh, Ankita; Al-Sadi, Azzat; Yazeedi, Talal Al; Mohammad, Rasheed; Cisse, Babacar; Garrett, Timothy J.; Uddin, Mohammed; Soares, Nelson C.; Backofen, Rolf; Alkhnbashi, Omer S.Accurate and rapid disease diagnosis, particularly in prostate cancer (PC) and breast cancer (BC), is critical for early intervention and improved patient outcomes. Metabolomic signatures represent a robust molecular framework for elucidating cancer-associated biochemical reprogramming. The use of artificial intelligence (AI) in biology in recent years has become widespread and promising. This study introduces a novel predictive method that integrates an Autoencoder, random forest-based feature selection and Tabular Prior-data Fitted Network (TabPFN) to achieve high diagnostic accuracy from metabolomics data of prostate and BC patients. The datasets were acquired using paper spray ionization mass spectrometry and flow injection-traveling-wave ion mobility-mass spectrometry of individuals diagnosed with PC and BC. When leveraging metabolomic profiling data from two distinct sources, PC urine and serum samples, the proposed model achieved an accuracy up to 98.75% in distinguishing diseased from healthy conditions. Additionally, we employed a BC dataset containing metabolic and lipidomic signatures acquired from core needle biopsies using a miniature MS platform coupled with PSI to assess the fidelity of our implementation across distinct cancer types. Our results on a well-characterized targeted dataset show that we can effectively reduce high-dimensional data into latent feature representations. At the same time, TabPFN captures tumor progression-related changes and feature interaction, thereby enhancing the possibility that the model will be a highly potent and effective tool for stage-specific diagnostic precision. Most existing machine learning approaches for disease diagnosis primarily rely on imaging, genomics, or clinical parameters, often overlooking the critical role of metabolites in identifying disease-specific biochemical signatures. By integrating metabolite-specific data with a robust deep-learning approach, this study demonstrates the transformative potential of AI in metabolomics-based diagnostics. The proposed model offers scalability and versatility, with applications extending beyond oncology to a much broader disease profiling aspect. These findings emphasize the value of combining multi-source metabolomic data with deep learning to advance personalized medicine and enhance diagnostic efficiency in clinical practice.
- Flavouring Group Evaluation 87, Revision 3 (FGE.87Rev3): Consideration of bicyclic secondary alcohols, ketones and related esters evaluated by JECFA (63rd meeting) structurally related to bicyclic secondary alcohols, ketones and related esters evaluated in FGE.47Rev1Publication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernández, María José; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Benigni, Romualdo; Degen, Gisela; Engel, Karl‐Heinz; Carfí, Maria; Martino, CarlaThe Panel on Food Additives and Flavourings (FAF) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No. 1565/2000. The present consideration concerns a group of 19 bicyclic secondary alcohols, ketones and related esters evaluated by JECFA at the 63rd meeting. This revision of FGE.87 is made due to new information on annual production volume, allowing the calculation of maximised survey‐derived daily intake (MSDI) for 4,4a,5,6‐tetrahydro‐7‐methylnaphthalen‐2(3H)‐one [FL‐no: 07.136]. In addition, new data on uses and use levels for the substances [FL‐no: 07.089, 07.0136, 07.153 and 07.159] have been provided and considered for the estimation of exposure (mTAMDI approach). For [FL‐no: 07.136], the Panel agrees with the Procedure as applied by JECFA and with JECFA conclusion: ‘No safety concern at estimated levels of intake as flavouring substance’, when based on the MSDI approach. For the other 18 substances considered in FGE.87Rev3, the same conclusion was already drawn in FGE.87Rev2. For [FL‐no: 07.136], the mTAMDI exposure estimate is below the TTC for structural class II substances. Accordingly, no further data are required in the context of the current evaluation programme. For [FL‐no: 07.089, 07.153, 07.159], mTAMDI exposure estimates are above the TTC for structural class II substances; therefore, more reliable data on uses and use levels should be provided in order to refine the exposure assessment and to finalise their safety evaluation. For the remaining 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessments and to finalise the evaluation. Information on specifications for the materials of commerce is considered adequate for all 19 substances.
- Safety evaluation of pectin‐rich extract derived from Coffea arabica as food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Mech, Agnieszka; Tard, Alexandra; Zakidou, Panagiota; Ruggeri, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pectin rich extract derived from Coffea arabica L. as a food additive. The proposed food additive consists of 70%–85% dietary fibres (of which the major part is pectin), 4%–6.5% proteins and substances of potential concern including caffeine, chlorogenic acid, ■■■■■, caffeic acid, ■■■■■, trigonelline. The Panel integrated all available information including existing EFSA evaluations on pectins, coffee fruit pulp, and conducted a new quantitative structure–activity relationship (QSAR) analysis for the substances of potential concern. Studies from literature confirmed that the pectins are not absorbed intact but extensively fermented by intestinal microbiota. No adverse effects were reported in two 90‐day toxicity studies in rats up to 7.8 g/kg body weight (bw) per day and in one human study on sugar beet pectin at 0.2 g/kg bw per day for 4 weeks. The calculated MOE for ■■■■■ indicated that there is a low concern from a public health point of view. The Panel considered that the exposure to caffeine, caffeic acid, ■■■■■, chlorogenic acid, ■■■■■ and trigonelline from use of the proposed food additive would contribute only to a minimal increase over existing dietary exposure and is not of safety concern. Considering the composition of the proposed food additive, the absence of genotoxic concern of its components and lack of adverse effects of the major component (i.e. pectins), the Panel considered that there was no need for a numerical acceptable daily intake. The Panel concluded that the use of pectin‐rich extract derived from Coffea arabica as a new food additive does not raise a safety concern at the proposed use and use levels.
- First identification and molecular characterization of CTX-M-15 extended-spectrum β-lactamase and OXA-9 β-lactamase in Haemophilus influenzae in the Iberian PeninsulaPublication . González-Díaz, A.; Pinto, M.; Cadenas-Jiménez, I.; Duarte, S.; Ardanuy, C.; Ribeiro, M.M.; Martí, S.; Bajanca-Lavado, P.We describe, for the first time, the presence and characterization of CTX-M-15 and OXA-9 in two Haemophilus influenzae strains: PTHi-14525 (CTX-M-15) from Portugal and HUB-HI042681 (OXA-9) from Spain. Multidrug-resistant PTHi-14525 carried blaCTX-M-15 (two copies) and blaTEM-1 in an ICEHpaHUB5-like element. HUB-HI042681, resistant to β-lactams and aminoglycosides, carried a novel ICEHinHUB1. These findings highlight the genomic plasticity and expanded resistome of H. influenzae, raising concerns about treatment and emphasizing the need for continuous genomic surveillance.