Safety and efficacy of a feed additive consisting of chromium propionate (KemTRACE™ chromium) for all growing poultry species (KEMIN EUROPA N.V).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of chromium propionate as zootechnical feed additive for all growing poultry species. The safety and efficacy of chromium propionate has been assessed previously in 2021 by the Panel and it was concluded that the additive is considered safe for chickens for fattening and chickens reared for laying/breeding at the proposed use level 0.2-0.

Modification of the terms of authorisation of the feed additive consisting of canthaxanthin for chickens for fattening, minor poultry species for fattening, laying poultry and poultry reared for laying, ornamental fish and ornamental birds and ornamental breeder hens to include canthaxanthin produced with CBS 146148 (DSM Nutritional Products Ltd.).

Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation of canthaxanthin, regarding the addition of a new production route, by the yeast CBS 146148. The additive is already authorised as sensory feed additive for use in feed for chickens for fattening, minor poultry species for fattening, laying poultry, poultry reared for laying, ornamental fish, ornamental birds and ornamental breeder hens. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that canthaxanthin produced with CBS 146148 is considered safe for the target species, the consumer and the environment under the current authorised conditions of use.

Modification of the terms of authorisation of the feed additive consisting of a preparation of canthaxanthin (CAROPHYLL® Red 10%) for breeder hens to include canthaxanthin produced with CBS 146148 (DSM Nutritional Products Ltd.).

Following a request from the European Commission, the EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation of the feed additive consisting of a preparation of canthaxanthin (CAROPHYLL® Red 10%), regarding the addition of a new production route, by the yeast CBS 146148 and to modify the additive specifications by substituting ethoxyquin by 4.4% butylated hydroxytoluene (BHT) and increasing the limit for dichloromethane to 80 mg/kg. The additive is already authorised as zootechnical feed additive for breeder hens.

Safety of the use of a microtracer with the feed additive consisting of chromium propionate (KemTRACE™ chromium) for all growing poultry species.

In the context of the FEEDAP opinion on the safety and efficacy of a feed additive consisting of chromium propionate (KemTRACE™ Chromium) of 18 March 2021, the EU Reference Laboratory for feed additives (EURL) was not in a position to recommend the method: proposed by the applicant for official control for the quantification of the organic chromium content in premixtures and feedingstuffs. The applicant subsequently proposed a new method of analyses, incorporating a tracer in the composition of a premix, which has been evaluated by EURL and recommended as official method for the quantification of the organic chromium content in premixtures and feedingstuffs. In view of the above, the Commission asked EFSA to issue a new opinion on the safety and efficacy of chromium proprionate (KemTRACE™ Chromium) as feed additive for all growing poultry species including the newly submitted information by the applicant that involves the use of the microtracer.

Acute suppurative thyroiditis in a child secondary to pyriform sinus fistula: From single case to systematic review.

Acute suppurative thyroiditis (AST), a rare yet potentially life-threatening infection, comprises less than 1 % of neck pathologies and requires prompt treatment. Symptoms range from neck pain and fever to dysphagia and possible abscess formation. Broad-spectrum antibiotics are the primary treatment; however, surgical drainage may be necessary for abscesses to prevent systemic infection.

Local and network changes after multichannel transcranial direct current stimulation using magnetoencephalography in patients with refractory epilepsy.

Objective: Non-invasive neuromodulation techniques, particularly transcranial direct current stimulation (tDCS), are promising for drug-resistant epilepsy (DRE), though the mechanisms of their efficacy remain unclear. This study aims to (i) investigate tDCS neurophysiological mechanisms using a personalized multichannel protocol with magnetoencephalography (MEG) and (ii) assess post-tDCS changes in brain connectivity, correlating them with clinical outcomes.

Methods: Seventeen patients with focal DRE underwent three cycles of tDCS over five days, each consisting of 40-minute stimulations targeting the epileptogenic zone (EZ) identified via stereo-EEG.

Medial pulvinar stimulation for focal drug-resistant epilepsy: interim 12-month results of the PULSE study.

Objective: This study aims to evaluate the efficacy and safety of deep brain stimulation (DBS) of the medial pulvinar nucleus (PuM) in reducing seizure frequency and addressing comorbidities in patients with drug and vagal nerve-resistant focal epilepsy.

Methods: This is an open-label prospective treatment trial with a planned enrollment of 12 patients suffering from medically refractory epilepsy (Clinical trial gov NCT04692701), for which the interim 12-month post-implantation results for the first 6 patients are being reported. Inclusion criteria were focal epilepsy not suitable for or after failed surgical intervention and previous failure of neurostimulation therapies (vagus nerve stimulation or anterior thalamic nucleus DBS).

Safety and efficacy of a feed additive consisting of NCIMB 41028 for all animal species (Genus Breeding Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of NCIMB 41028 as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 10 colony forming units (CFU)/kg fresh plant material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment.

Safety and efficacy of a feed additive consisting of NCIMB 30148 for all animal species (Genus Breeding Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of NCIMB 30148 as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 10 colony forming units (CFU)/kg fresh plant material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment.

Stereoelectroencephalographic thermocoagulation in FLNA-positive heterotopia: Is it an effective treatment?

Periventricular nodular heterotopia (PVNH) is a neuronal migration disorder often associated with drug-resistant epilepsy. The epileptogenic zone network (EZN) in PVNH is generally large, contraindicating surgery. Stereoelectroencephalography (SEEG) can be proposed to map the EZN and perform radiofrequency thermocoagulation (THC) with an efficacy rate of approximately 65%.

Safety and efficacy of a feed additive consisting of ponceau 4R for its use in baits for freshwater fish (GIFAP).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ponceau 4R as sensory additives (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). The additive is already authorised for use with cats and dogs and ornamental fish. The additive is intended to be incorporated in freshwater fishing baits up to a maximum of 15 mg/kg in complementary feed in order to colour them.

Safety of a feed additive consisting of vitamin B/riboflavin produced with CCTCCM 2019833 for all animal species (Hubei Guangji Pharmaceutical Co., Ltd).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of a feed additive consisting of vitamin B/riboflavin produced with CCTCCM 2019833 intended for use as a nutritional additive (functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effects) for all animal species. The characterisation, safety and efficacy of the additive have been already assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the target species, consumers and the users due to lack of reliable toxicological data. In the present assessment, the applicant submitted new genotoxicity and repeated dose oral toxicity studies.

Assessment of the feed additive consisting of ammonium propionate for all terrestrial animal species for the renewal of its authorisation (BASF SE, Tamnico Finland Oy).

Ammonium propionate is authorised as a liquid preparation of ≥ 19% ammonium propionate, ≤ 80% propionic acid and ≤ 30% water. The applicant requested for the renewal of the authorisation of ammonium propionate when used as a feed additive for all terrestrial animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation.

Safety and efficacy of a feed additive consisting of tartrazine for its use in baits for freshwater fish (GIFAP).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tartrazine as sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). Tartrazine is intended to be incorporated in fishing baits up to a maximum of 30 mg/kg in complementary feed in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture.

Assessment of the feed additive consisting of propionic acid for all terrestrial animal species for the renewal of its authorisation (Eastman Chemical B.V., Perstorp AB, Dow Europe GmbH, BASF SE).

Propionic acid is currently authorised as a technological additive (functional group: silage additives) for all animal species. The applicants requested for the renewal of the authorisation of propionic acid when used as a feed additive for all terrestrial animal species. The applicants have provided evidence that the additive in the market complies with the conditions of the authorisation.

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced with CBS 114044 (ECONASE® XT) for pigs for fattening, laying hens and minor poultry species (AB Enzymes Finland Oy).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product containing endo-1,4-β-xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products.

Safety and efficacy of a feed additive consisting of fumaric acid for all animal species for the renewal of its authorisation and extension of use (Life SUPPLIES NV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of fumaric acid as a technological and sensory additive (functional groups: preservative and flavouring compounds, respectively) and for a new use of the additive as a technological additive (functional group: acidity regulator) for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that fumaric acid remains safe under the authorised conditions of use for the terrestrial animals, consumers and the environment.

Safety and efficacy of a feed additive consisting of a C.Abel seed extract for use in all animal species except fin fish (NOR-FEED SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a C.Abel seed extract (Cosap®) as technological feed additive for all animal species except fin fish. In the absence of adequate tolerance studies in the target species or toxicological studies with the additive under assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of extract for the target species.

Differential Regulation of Wingless-Wnt/c-Jun N-Terminal Kinase Crosstalk via Oxidative Eustress in Primary and Metastatic Colorectal Cancer Cells.

In the tumor microenvironment (TME), ROS production affects survival, progression, and therapy resistance in colorectal cancer (CRC). HO-mediated oxidative stress can modulate Wnt/β-catenin signaling and metabolic reprogramming of the TME. Currently, it is unclear how mild/moderate oxidative stress (eustress) modulates Wnt/β-catenin/APC and JNK signaling relationships in primary and metastatic CRC cells.

Impact of transcranial electrical stimulation on simultaneous stereoelectroencephalography recordings: A randomized sham-controlled study.

Objective: Clinical exploitation of transcranial electrical stimulation for focal epilepsy treatment lacks quantification of the underlying neurophysiological changes. This study explores the immediate effects of transcranial alternating (tACS) and direct (tDCS) current stimulation on local and network brain activity using simultaneous stereoelectroencephalography (SEEG) recordings.

Methods: Patients were randomized for personalized tACS (n = 5) or tDCS (n = 6).

Prognostic value of the 5-SENSE Score to predict focality of the seizure-onset zone as assessed by stereoelectroencephalography: a prospective international multicentre validation study.

Introduction: Epilepsy surgery is the only curative treatment for patients with drug-resistant focal epilepsy. Stereoelectroencephalography (SEEG) is the gold standard to delineate the seizure-onset zone (SOZ). However, up to 40% of patients are subsequently not operated as no focal non-eloquent SOZ can be identified.

Assessment of the feed additive consisting of sodium propionate for all terrestrial animal species for the renewal of its authorisation (BASF SE).

Sodium propionate is authorised containing at least 98.5% of sodium propionate. The applicants requested for the renewal of the authorisation of sodium propionate when used as a feed additive for all terrestrial animal species.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the fruit of L. (caraway oil) for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the fruit of L. (caraway oil), when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel concluded that the use of caraway oil is of no concern up to the following concentrations in complete feed: 9 mg/kg for chickens for fattening, 13 mg/kg for laying hens, 12 mg/kg for turkeys for fattening, 16 mg/kg for piglets, 19 mg/kg for pigs for fattening, 24 mg/kg for sows, 35 mg/kg for veal calves (milk replacer), 11 mg/kg for cattle for fattening, 10 mg/kg for dairy cows, sheep, goats, horses and rabbits, 25 mg/kg for salmonids and dogs.

Modification of the terms of authorisation regarding the additive consisting of liquid l-lysine base produced with NRRL B-67439 and NRRL B-67535 for all animal species (ADM specialty ingredients (Europe) B.V.).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of liquid l-lysine base produced with a genetically modified strain of as a nutritional feed additive for all animal species. The l-lysine base liquid produced with NRRL B-67535 and NRRL B-67439 is currently authorised as a nutritional additive for all animal species. The present application is aimed at modifying the current authorisation to include NRRL B-68248 as a production strain.