Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283.

The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food.

Anterior approach with or without liver hanging maneuver versus conventional approach in major liver resections. A systematic review and meta-analysis of randomized controlled trials.

Introduction: The anterior approach (AA), whether or not associated with the liver hanging maneuver (LHM), has been advocated to improve survival and postoperative outcomes in HCC patients undergoing major liver resection. This systematic review and meta-analysis of randomized controlled trials aims to explore intra/perioperative and long-term survival outcomes of AA ± LHM compared to CA regardless of tumor histology.

Methods: The study was conducted according to the Cochrane recommendations searching the PubMed, Scopus, and EMBASE databases until January 27, 2024 (PROSPERO ID: CRD42024507060).

Three-dimensional reconstruction technology in the preoperative workup of complex hepatic resections. Our experience on 11 consecutive cases.

Three-dimensional liver modeling can be a useful tool when planning the preoperative strategy in liver surgery. The present study aims to review our case series of patients requiring complex hepatic resections for primary and secondary liver tumors, and for whom 3D models were built, to add further evidence in this direction. All consecutive patients undergoing complex liver resection were enrolled.

The impact of 3D reconstruction technology on liver surgery in changing the pathway of surgical maneuvers: A case report.

Introduction: This case report illustrates the significant role that 3D technology can play in major hepatic surgery, aiding in the determination of the optimal surgical approach.

Case Presentation: We present the case of a patient with metachronous liver metastasis from rectal cancer involving segments 6 and 7, extending to retroperitoneal structures such as the inferior vena cava (IVC) and the right renal vein (RRV).

Discussion: After confirming the feasibility of a right hepatectomy, we opted for a traditional posterior approach, avoiding the hanging maneuver.

Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment.

The European Union (EU) is committed to transitioning toward a circular economy model, with food waste being one of the areas to be targeted. To close the loop of food waste generated during food processing and discarded at the retail or consumption phases, research and innovation parties proposed to valorize agro-food by-products to produce novel foods and food improvement agents (food additives, food enzymes, and food flavorings). In the EU, the authorization of such novel foods and food improvement agents is governed by different regulatory frameworks.

Undifferentiated Embryonal Sarcoma of the Liver with Epithelioid Features: A Case Report of an Exceptional Histological Heterogeneity among Rare Diseases.

Introduction: Undifferentiated embryonal sarcoma of the liver (UESL) is a rare and aggressive malignant tumor, with nonspecific clinical symptoms and radiological features. Less than 150 cases have been reported in adults across the world.

Presentation Of Case: We report a case of an extremely rare subtype of UESL with epithelioid features in a 29-year-old woman, presenting as a cystic lesion of 27 × 17 cm, completely subverting the right hepatic lobe.

Short-Term Outcomes after D2 Gastrectomy with Complete Mesogastric Excision in Patients with Locally Advanced Gastric Cancer: A Systematic Review and Meta-Analysis of High-Quality Studies.

Complete mesogastric excision (CME) has been advocated to allow for a more extensive retrieval of lymph nodes, as well as lowering loco-regional recurrence rates. This study aims to analyze the short-term outcomes of D2 radical gastrectomy with CME compared to standard D2 gastrectomy. A systematic review of the literature was conducted according to the Cochrane recommendations until 2 July 2023 (PROSPERO ID: CRD42023443361).

Dynamic surgical anatomy using 3D reconstruction technology in complex hepato-biliary surgery with vascular involvement. Results from an international multicentric survey.

Introduction: Three-dimensional liver modeling can lead to substantial changes in choosing the type and extension of liver resection. This study aimed to explore whether 3D reconstruction helps to better understand the relationship between liver tumors and neighboring vascular structures compared to standard 2D CT scan images.

Methods: Contrast-enhanced CT scan images of 11 patients suffering from primary and secondary hepatic tumors were selected.

Conversion Strategy in Left-Sided RAS/BRAF Wild-Type Metastatic Colorectal Cancer Patients with Unresectable Liver-Limited Disease: A Multicenter Cohort Study.

Colorectal cancer (CRC) patients frequently develop liver metastases. Different treatment strategies are available according to the timing of appearance, the burden of metastatic disease, and the performance status of the patient. Systemic treatment (ST) represents the cornerstone of metastatic disease management.

Statement on safety of cannabidiol as a novel food: data gaps and uncertainties.

The European Commission has determined that cannabidiol (CBD) can be considered as a novel food (NF), and currently, 19 applications are under assessment at EFSA. While assessing these, it has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed.

Safety of iron hydroxide adipate tartrate as a novel food pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC.

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 iron hydroxide adipate tartrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC. The NF is intended to be used in food supplements up to a maximum dose of 100 mg per day, corresponding to a maximum daily intake of iron of 36 mg. The target population proposed by the applicant is the general population above 3 years of age.

Surgical treatment of gastric cancer liver metastases: Systematic review and meta-analysis of long-term outcomes and prognostic factors.

The prognosis of patients with metastatic gastric cancer remains dismal, with palliative treatment as standard of care. However, encouraging results have been reported for surgical resection of liver only metastatic gastric cancer in carefully selected patients. A systematic review of articles published from 2000 onwards was conducted according to PRISMA guidelines.

Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority.

The European Food Safety Authority (EFSA) has been involved in the risk assessment of novel foods since 2003. The implementation of the current novel food regulation in 2018 rendered EFSA the sole entity of the European Union responsible for such safety evaluations. The risk assessment is based on the data submitted by applicants in line with the scientific requirements described in the respective EFSA guidance document.

Angiotensin Receptor 1 Blockers Prolong Time to Recurrence after Radiofrequency Ablation in Hepatocellular Carcinoma patients: A Retrospective Study.

Inhibition of angiotensin II synthesis seems to decrease hepatocellular carcinoma recurrence after radical therapies; however, data on the adjuvant role of angiotensin II receptor 1 blockers (sartans) are still lacking. Aim of the study was to evaluate whether sartans delay time to recurrence and prolong overall survival in hepatocellular carcinoma patients after radiofrequency ablation. Data on 215 patients were reviewed.

Scientific opinion on the safety of selenite triglycerides as a source of selenium added for nutritional purposes to food supplements.

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 selenite triglycerides as a novel food (NF) pursuant to Regulation (EU) 2015/2283, their safety when added for nutritional purposes to food supplements as a source of selenium and the bioavailability of selenium from this source, in the context of Directive 2002/46/EC. The proposed NF is the first lipophilic organic form of selenium so far described in the literature. It is composed by a mixture of individual Se-containing lipids which do not occur in nature.

Calcium l-methylfolate as a source of folate added for nutritional purposes to infant and follow-on formula, baby food and processed cereal-based food.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the extension of use of calcium l-methylfolate to be used as a source of folate added for nutritional purposes to infant and follow-on formula, baby food and processed cereal-based food pursuant to Regulation (EU) 609/2013. In 2004, EFSA assessed the use of calcium l-methylfolate as a source of folate in foods for particular nutritional uses, food supplements and foods intended for the general population. The new alternative synthetic step proposed to produce the nutrient source, using platinum as a catalyst, did not raise any safety concern and the production process was found to consistently yield a product in line with the proposed specifications.

Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch-to-batch variability and stability of the NF do not raise safety concerns.

Comparison Between Swan-Ganz Catheter and Minimally Invasive Hemodynamic Monitoring During Liver Transplantation: Report of a Monocentric Case Series.

Introduction: The aim of the present investigation was to retrospectively evaluate the utilization of Swan-Ganz catheter during orthotopic liver transplantation as opposed to FloTrac/Vigileo in selected cases, comparing a number of clinical outcomes across postoperative hospitalization.

Materials And Methods: Before 2015 all recipients received pulmonary artery catheter (Swan-Ganz group, n = 109). After 2015 Swan-Ganz was used only if coronary artery disease or high-grade portal hypertension or Child-Pugh C were present; the remaining recipients were assigned to FloTrac/Vigileo monitoring (Mini group, n =100).

Statement on the safety of d-ribose.

In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d-ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d-ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was asked to carry out a supplementary safety assessment for d-ribose by considering the new proposed uses and use levels submitted by the applicant. In order to address the present mandate, an intake assessment was carried out based on individual data from the EFSA Comprehensive European Food Consumption Database.