Assessment of the feed additive consisting of robenidine hydrochloride (Cycostat® 66G) for rabbits for breeding and rabbits for fattening for the renewal of its authorisation (Zoetis).

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 feed additive consisting of robenidine hydrochloride (Cycostat® 66G) for rabbits for breeding and rabbits for fattening for the renewal of its authorisation. Since the potential aneugenic activity of robenidine hydrochloride cannot be excluded, the FEEDAP Panel is not in the position to conclude on the safety of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety of robenidine hydrochloride for the environment.

Safety and efficacy of the feed additives 2-acetylfuran [13.054] and 2-pentylfuran [13.059] belonging to chemical group 14 for 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 2-acetylfuran [13.054] and 2-pentylfuran [13.059] belonging to chemical group 14 (furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms), when used as sensory additives (flavourings) in feed for all animal species.

Safety and efficacy of a feed additive consisting of DSM 5749 and DSM 5750 (BioPlus® 2B) for piglets, calves for fattening and other growing ruminants (Chr. Hansen A/S).

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 and efficacy of a feed additive consisting of two bacilli strains (tradename: BioPlus® 2B) when used in suckling piglets, calves for fattening and other growing ruminants. BioPlus® 2B is composed of viable cells of DSM 5750 and DSM 5749. In the course of the current assessment, the latest strain was reclassified as .

Efficacy of a feed additive consisting of strains CNCM I-4606, CNCM I-5043 and CNCM I-4607 and CNCM I-4609 for all animal species (MiXscience).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of the preparation consisting of viable cells of CNCM I-4606, CNCM I-5043, CNCM I-4607 and CNCM I-4609 when used as a technological additive (hygiene condition enhancer) for all animal species. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for the target species, consumers and the environment. The Panel also considered the additive to be non-irritant to skin and eyes, nor a dermal sensitiser, but a respiratory sensitiser.

Safety and efficacy of a feed additive consisting of semi-refined carrageenan for cats and dogs (Gel Systems Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of semi-refined carrageenan as a feed additive for cats and dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that semi-refined carrageenan was safe for dogs at 6,000 mg/kg final wet feed (with about 20% dry matter). This would correspond to 26,400 mg semi-refined carrageenan/kg complete feed (with 88% dry matter).

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 avian species (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 to be used as a zootechnical additive (functional group: other zootechnical additives) for all avian species. The additive (tradename Bafasal®) is not currently authorised in the European Union.

Assessment of the feed additive consisting of DSM 23376 for all animal species for the renewal of its authorisation (Agri-King, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of DSM 23376, as a technological additive to improve ensiling of forage for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions.

Safety and efficacy of a feed additive consisting of a tincture derived from the roots of (Rupr. & Maxim.) Maxim. (taiga root tincture) for use in dogs, cats and horses (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of (Rupr. & Maxim.) Maxim.

Safety and efficacy of a feed additive consisting of endo-1,4-β-d-mannanase produced by DSM 33149 (Natupulse® TS/TS L) for chickens and turkeys for fattening, minor poultry species for fattening and ornamental birds (BASF SE).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-β-d-mannanase produced by DSM 33149 (Natupulse® TS/TS L) as a zootechnical feed additive for chickens and turkeys for fattening, minor poultry species for fattening and ornamental birds. The additive under assessment, Natupulse® TS/TS L, does not pose any safety concern regarding the production strain. The FEEDAP Panel concluded that the additive is tolerated by chickens for fattening, and this conclusion can be extrapolated to all poultry for fattening.

Assessment of eight feed additives consisting of CNCM I-3235, CNCM I-3736/DSM 11672, CNCM I-3237, CNCM I-4622/DSM 11673, NCIMB 12455, CNCM I-4661, NCIMB 40788/CNCM I-4323 and NCIMB 40788/CNCM I-4323 plus CNCM I-4785 for all animal species for the renewal of their authorisation (Danstar Ferment AG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of eight technological additives, including two (formerly ) [CNCM I-3235 and CNCM I-3736/ DSM 11672], two [CNCM I-3237 and CNCM I-4622/DSM 11673] one [NCIMB 12455], one (formerly ) [CNCM I-4661], one (formerly ) [NCIMB 40788/ CNCM I-4323], and the additive composed by the two active agents NCIMB 40788/ CNCM I-4323 and (formerly ) CNCM I-4785, as silage additives for use in forage for all animal species. The applicant has provided evidence that the additives currently on the market comply with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions.

Assessment of the application for renewal of the authorization of a feed additive consisting of urea for ruminants (Borealis L.A.T. GmbH, SKW Stickstoffwerke Piesteritz GmbH and Yara France).

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 urea as nutritional feed additive. The additive is authorised for use in ruminants with functional rumen (3d1). The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been substantially modified.

Safety and efficacy of a feed additive consisting of copper(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of a copper(II)-betaine complex as nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chicken, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of copper in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum copper levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the copper(II)-betaine complex in animal nutrition at the maximum copper levels authorised for the animal species poses no concern to the safety of consumers.

Safety and efficacy of a feed additive consisting of DSM 13084/ATCC BAA 1024 for dogs and cats (BLIS Technologies Limited).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of DSM 13084/ATCC BAA 1024 as a technological additive (functional group: acidity regulators) in feed for dogs and cats. The additive is intended for use at a proposed minimum concentration of 1 × 10 CFU/l or kg liquid feed for dogs and cats. Due to the lack of adequate data, the FEEDAP Panel could not conclude on the safety of the additive for the target species.

Safety of a feed additive consisting of a tincture derived from the roots of L. (gentian tincture) for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of a tincture derived from L. (gentian tincture). It is intended to be used as a sensory additive for all animal species.

Safety and efficacy of a feed additive consisting of vitamin B2 (riboflavin) produced by CGMCC 13326 for all animal species (Kempex Holland B.V.).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B2 (riboflavin) produced by CGMCC 13326 as a nutritional feed additive for all animal species. The additive is produced by a genetically modified production strain. Although the production strain harbours some genes coding for resistance to antimicrobials, viable cells and DNA of the production strain were not detected in the final product.

Safety and efficacy of a feed additive consisting of endo-1,4-β-d-mannanase produced by DSM 33618 (Hemicell® HT/HT-L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-β-d-mannanase (Hemicell® HT/HT-L) produced by a genetically-modified strain of (DSM 33618) as a zootechnical feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, piglets (weaned) and minor porcine species. The production strain was obtained from a recipient strain that has been evaluated previously by EFSA and considered to be safe. The genetic modification does not raise safety concerns and there were no antibiotic resistance genes from the genetic modification in the production strain.

Safety and efficacy of a feed additive consisting of a zinc(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a zinc(II)-betaine complex as nutritional additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion could be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded.

Safety and efficacy of a feed additive consisting of (formerly ) DSM 33625 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 (formerly ) DSM 33625 when used as a technological additive to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 10 colony forming units (CFU)/kg forage. 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 endo-1,4-beta-xylanase produced by ATCC PTA-5588, protease produced by CBS 148232, and alpha-amylase produced by ATCC SD-6525 (Axtra® XAP 104 TPT) for chickens for fattening, laying hens and minor poultry species (Genencor international B.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-beta-xylanase produced by ATCC PTA-5588, protease produced by CBS 148232, and alpha-amylase produced by ATCC SD-6525, Axtra® XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the ■■■■■ used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase.

Modification of the conditions of the authorisation of FERM BP-2789 (Miya-Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd).

The additive Miya-Gold® consists of viable cells of FERM BP-2789.The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and piglets of minor porcine species. The authorisation for chickens and minor poultry species for fattening and reared for laying is at a minimum level of 2.

Safety of 27 flavouring compounds providing a milky-vanilla flavour and belonging to different chemical groups for use as feed additives in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 27 compounds to provide a milky-vanilla flavour belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fifteen of the 27 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. No adverse effects were observed in the tolerance studies at 10-fold the intended level.

Tissue-Resident Memory T Cells in Pancreatic Ductal Adenocarcinoma Coexpress PD-1 and TIGIT and Functional Inhibition Is Reversible by Dual Antibody Blockade.

Pancreatic ductal adenocarcinoma (PDAC) has a poor clinical outlook. Responses to immune checkpoint blockade are suboptimal and a much more detailed understanding of the tumor immune microenvironment is needed if this situation is to be improved. Here, we characterized tumor-infiltrating T-cell populations in patients with PDAC using cytometry by time of flight (CyTOF) and single-cell RNA sequencing.

Safety of a feed additive consisting of sodium saccharin for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sodium saccharin as a sensory feed additive (flavouring compound) for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening. In a previous assessment, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) could not conclude on the safety of the additive for the environment because concentrations of the additive or its degradation product 4-hydroxysaccharin in groundwater above 0.1 μg/L were likely to occur.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of L. (dill tincture) for use in 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 a tincture from the fruit of L. (dill tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 0.

Safety and efficacy of a feed additive consisting of endo-1,3(4)-beta-glucanase produced by CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG).

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 endo-1,3(4)-beta-glucanase produced by CBS 589.94 (RONOZYME® VP (CT/L)) as a zootechnical feed additive for chickens for fattening and weaned piglets. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats and the tolerance trials provided, the additive was considered safe for chickens for fattening and weaned piglets at the proposed conditions of use.