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.

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.

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.

In Situ Potentiometric Monitoring of Nitrate Removal from Aqueous Solution by Activated Carbon and Ion Exchange Resin.

A nitrate selective electrode was used for real-time in situ potentiometric monitoring of a batch nitrate removal process using activated carbon and ion exchange resin. A plasticized polymeric membrane consisting of polyvinyl chloride, 2-nitrophenyl octyl ether and tridodecyl methyl ammonium chloride was incorporated into an ion-selective electrode body. First, the dynamic potential response of the electrode to nitrate was investigated.

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 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.

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.

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.

Safety and efficacy of a feed additive consisting of DSM 34262 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 34262 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in easy and moderately difficult to ensile 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.

Safety and efficacy of a feed additive consisting of DSM 34271 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 34271 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in easy and moderately difficult to ensile 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.

Safety of a feed additive consisting of sepiolite for all animal species (Sepiol S.A. and Tolsa S.A.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sepiolite as a technological feed additive for all animal species. In 2022, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of the same additive. The Panel concluded that sepiolite used as a feed additive is safe for the consumers and the environment, and efficacious as a thickener-suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use.

Guidance on the assessment of the efficacy of feed additives.

This guidance document is intended to assist the applicant in preparing and presenting an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the efficacy of feed additives.

Safety and efficacy of a feed additive consisting of Molina and Roezl ex Ortgies (Magni-PHI®) for all poultry species (to slaughter age/weight, or to the point of lay) and ornamental birds (Phibro Animal Health Corporation).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of powder and powder (Magni-Phi®) for all avian species (to slaughter age/weight, or to the point of lay) and ornamental birds, as a zootechnical additive (digestibility enhancer and other zootechnical additives). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening at the level of 250 mg/kg complete feed with a margin of safety of 20 assuming that the additive contains 3.58% of saponins.

Safety and efficacy of a feed additive consisting of alpha-amylase (produced with DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha-amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations.

Safety and efficacy of a feed additive consisting of 6-phytase produced with (CBS 126897) (Quantum® Blue) for fin fish (ROAL Oy).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 6-phytase (Quantum® Blue) as a zootechnical feed additive for fin fish. The additive is authorised for use in poultry and pigs. The additive is available in solid and liquid forms, and the 6-phytase contained in the product is produced by fermentation with a genetically modified strain of .

Efficacy of a feed additive consisting of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with IMI 378536 and DSM 26702 (ROVABIO® ADVANCE) for weaned piglets (Adisseo France SAS).

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 efficacy of ROVABIO® ADVANCE (liquid and solid) which contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with IMI 378536 and DSM 26702 as a zootechnical feed additive for weaned piglets at the recommended use level of 1800 U xylanase and 1250 U glucanase per kg feed. In a previous assessment, three long-term trials in weaned piglets were submitted. Two of them were considered to support the efficacy of the additive while a third trial was not further considered due to the large number of veterinary treatments applied.

Safety and efficacy of a feed additive consisting of DSM 34246 (Canobios-BL) for cats and dogs (ACEL pharma s.r.l.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of DSM 34246 as a zootechnical feed additive for dogs and cats. The additive, with the trade name Canobios-BL, is intended for use in feed for cats and dogs at a proposed minimum inclusion level of 5 × 10 CFU/kg complete feed. 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 muramidase produced with DSM 32338 (Balancius™) for laying hens (DSM nutritional products).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of muramidase produced with DSM 32338 (Balancius™) as a feed additive for laying hens. The additive is already authorised as a zootechnical additive (functional group: other zootechnical additives) for chickens, turkeys and minor poultry species for fattening or reared for breeding, and for weaned piglets. The enzyme is produced by fermentation with a genetically modified strain of viable cells of the production strain and its recombinant DNA were not detected in the additive.

Efficacy of a feed additive consisting of ferrous lysinate sulfate for all animal species (Phytobiotis Futterzusatzstoffe GmbH).

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 efficacy of ferrous lysinate sulfate (Plexomin® L-Fe) for all animal species. The additive has not been previously authorised as a feed additive in the European Union (EU). The safety of the additive for the target species, consumer, user and the environment has already been assessed in previous opinions.

Efficacy of the feed additive consisting of CNCM I-4407 (Actisaf® Sc47) for cattle for fattening (Lesaffre International).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of CNCM I-4407 (Actisaf® Sc47) as a zootechnical feed additive (functional group: gut flora stabiliser) in cattle for fattening. The additive is already authorised for use in feed for dairy cows, calves for rearing, lambs for fattening, dairy goats, dairy sheep and dairy buffaloes. In a previous opinion, the EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that Actisaf® Sc47 was safe for cattle for fattening, the consumers and the environment.

Efficacy of a feed additive consisting of DBVPG 48 SF (BioCell®) for ruminants (Mazzoleni S.p.A.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs. However, the Panel was not in the position to conclude on the efficacy of BioCell® for calves, and, consequently, for other ruminants for fattening or rearing.