Assessment of the feed additive consisting of NCIMB 30005 for all animal species for the renewal of its authorisation (Microferm ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of a preparation of NCIMB 30005 as technological additive to improve ensiling of fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions for all animal species, consumers and the environment, for which the additive is considered to remain safe.

Assessment of the feed additive consisting of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase (produced with IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase (produced with IMI CC 378536) (Rovabio® Excel) for the renewal of its authorisation as a zootechnical feed additive for all poultry species, weaned piglets, pigs for fattening and sows. The applicant provided evidence that the additive complies with the conditions of the authorisation. The FEEDAP Panel concluded that the additive in all its formulations remains safe for all poultry species, weaned piglets, pigs for fattening and sows, and remains safe for consumers and the environment.

Safety and efficacy of a feed additive consisting of NCIMB 30094 for all animal species (Volac International Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of NCIMB 30094 as a technological additive (functional group: silage additive) for use in fresh material for all animal species. The additive is intended for use 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.

No Obesity Paradox for Health-Related Quality of Life in Patients with Heart Failure and Reduced Ejection Fraction: Insights from the VIDA Multicenter Study.

Previous studies showed that, paradoxically, obese patients with heart failure (HF) have better clinical outcomes compared to overweight, normal, or underweight patients. Scientific societies emphasize the importance of integrating quality of life (QoL) assessment in cardiovascular care. However, the association between QoL and weight remains understudied.

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.

Assessment of the feed additive consisting of NCIMB 40027 for all animal species for the renewal of its authorisation (Volac International ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of NCIMB 40027 as a technological additive (functional group: silage additives) for use in fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers, and the environment.

Safety and efficacy of a feed additive consisting of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 (Bafasal®) for all poultry (Proteon Pharmaceuticals S.A.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of four bacteriophages infecting ser. Gallinarum B/00111, intended for be as a zootechnical additive (functional group: other zootechnical additives) for all poultry species. Bafasal® is proposed for use in water for drinking and liquid complementary feed to guarantee a minimum daily dose of 2 × 10 PFU/bird, to reduce the spp.

Assessment of the feed additive consisting of NCIMB 30151 for all animal species for the renewal of its authorisation (Microferm ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of a preparation of NCIMB 30151 as a technological additive to improve ensiling of fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence that would lead to the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions for all animal species, consumers and the environment, for which the additive is considered to remain safe.

Assessment of the modification of the authorisation of the feed additive consisting of CNCM I-1077 for lambs and its extension of use to all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses (Lallemand SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of CNCM I-1077 as a zootechnical feed additive for several animal species. The additive, existing in a not-coated and a coated form, is currently authorised for use in feed for calves, cattle for fattening, dairy cows, dairy goats and dairy sheep, lambs, all minor ruminant species for fattening and rearing, horses and camelids for fattening and rearing. This application regards the request for the extension of use in all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses, and the modification of the authorisation for lambs to reduce the minimum use level.

Adherence to periprocedural antithrombotic treatment recommendations and its prognostic impact in patients with high ischemic and hemorrhagic risk.

Introduction And Objectives: To analyze the clinical impact of the inappropriate use of antithrombotic treatment in patients with high ischemic or hemorrhagic risk during the periprocedural/perisurgical period in Spain.

Methods: Prospective multicenter observational registry of patients receiving antiplatelet and/or anticoagulant therapy who required an intervention. The incidence of 30-day events was compared based on the peri-intervention management of antithrombotic treatment and the patients' risk classification (high vs.

Safety and efficacy of a feed additive consisting of DSM 33862 and DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on a formulation of DSM 33862 and DSM 12856 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with fresh plant material with a dry matter (DM) range of 32%-65% at a proposed minimum concentration of 1 × 10 colony forming units (CFU)/kg fresh plant material to be used for all animal species. The bacterial species and are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment.

Efficacy of the feed additives consisting of ATCC 53519 and ATCC 55593 as silage additives for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives (functional group: silage additives) consisting of strains ATCC 53519 and ATCC 55593, respectively. The additives are intended for use with all types of fresh materials and for all animal species at a proposed minimum concentration of 1 × 10 colony-forming units of ATCC 53519/kg fresh material or 5 × 10 CFU of ATCC 55593/kg fresh material. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy since the dry matter content of the ensiled materials at the end of the experiments was not corrected for volatiles, which led to unreliable estimation of the dry matter loss, and the lack of positive effects on any of the other parameters.

Safety and efficacy of a feed additive consisting of NCYC R618 (Benesacc®) for chickens for fattening and other poultry species for fattening and reared for laying (Global Nutritech Biyoteknoloji Ltd. Sti).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of NCYC R618 as a zootechnical feed additive (functional group: gut flora stabiliser) for chickens for fattening and other poultry species for fattening and reared for laying. The additive has never been authorised. The strain under assessment (NCYC R618) qualifies for the qualified presumption of safety (QPS) and, consequently, the FEEDAP Panel concluded that the product is safe for the target species, the consumers and the environment.

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 of a feed additive consisting of 3-phytase produced with CECT 13171 (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species for fattening (Fertinagro Biotech S.L.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of the feed additive consisting of 3-phytase produced with a genetically modified strain of (CECT 13171). The additive is intended to be used as a zootechnical additive for poultry species, pigs for fattening and minor porcine species for fattening. In a previous opinion, the EFSA Panel on Additives and Products or Substance used in Animal Feed (FEEDAP) Panel could not conclude on the taxonomic identification of the production strain.

Safety and efficacy of a feed additive consisting of l-valine produced with CGMCC 22721 for all animal species (Eppen Europe SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-valine produced by fermentation with a genetically modified strain of (CGMCC 22721) as a nutritional additive for all animal species. The production strain and its DNA were not detected in the final additive. Therefore, the final product does not give raise to any safety concern regarding the genetic modification of the production strain.

Safety and efficacy of a feed additive consisting of DSM 32651 for all animal species (BioCC OÜ).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of DSM 32651 when used 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.

Diagnostic and Therapeutic Approaches for Heart Failure in Long-Term Survivors of Childhood Cancer.

The improvement in survival rates in pediatric malignancies has led to an increase in the number of cancer survivors who are at risk of developing cardiotoxicity and heart failure. Cardiac dysfunction in these patients can occur asymptomatically, and the diagnosis in a symptomatic phase is associated with reduced treatment response and worse prognosis. For this reason, it is essential to establish protocols to follow up on these patients and identify those at risk of cardiotoxicity in order to start early and effective therapies.

Assessment of the feed additive consisting of endo-1,4-beta-xylanase (produced with MUCL 49755) and endo-1,3(4)-beta-glucanase (produced with MUCL 49754) (AveMix® XG 10) for pigs for fattening, minor porcine species for fattening and turkeys for fattening for the renewal of its authorisation (AVEVE BV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the feed additive consisting of endo-1,4-beta-xylanase (produced with MUCL 49755) and endo-1,3(4)-beta-glucanase (produced with MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) for the renewal of its authorisation as zootechnical feed additive for pigs for fattening, minor porcine species for fattening and turkeys for fattening. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive Avemix® XG 10 with calcium carbonate + wheat flour and Avemix® XG 10 L comply with the conditions of the authorisation.

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.

Assessment of the feed additive consisting of DSM 16680 for all animal species for the renewal of its authorisation (Microferm Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application of renewal of DSM 16680 as a technological feed additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment.

Safety and efficacy of a feed additive consisting of DSM 34345 as a silage additive for all animal species (Lactosan GmbH & Co.KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on DSM 34345 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with all fresh plant 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.

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.

Safety of a feed additive consisting of indigo carmine for cats, dogs and ornamental fish (Sensient Colors Europe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of indigo carmine as a colourant feed additive for cats, dogs and ornamental fish. In its previous opinion, the FEEDAP Panel concluded that indigo carmine is safe for cats and dogs at levels up to 250 mg/kg complete feed and for ornamental fish up to 1000 mg/kg complete feed. These conclusions were limited to indigo carmine with a purity of at least 93% colouring matter.