Safety and efficacy of a feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) IMI 507026 for all animal species (ALL‐TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland])

[EN]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 Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) IMI 507026 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 109 colony forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 109 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.S

Assessment of the feed additive consisting of Lactiplantibacillus plantarum DSM 16627 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 Lactiplantibacillus plantarum DSM 16627 as a technological additive to improve ensiling of fresh plant 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. Regarding the user safety, the additive is a preparation containing a microorganism and therefore should be considered a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. In the absence of data, no conclusion could be drawn on the eye irritation potential of the additive. There is no need for assessing the efficacy of the additive in the context of renewal of the authorisation. (EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

Assessment of the feed additive consisting of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG)

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 assessment of the application for renewal of authorisation of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 as a technological additive for use in forage for all animal species. The additive aims at improving the production of silage and is authorised 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 evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety L. buchneri DSM 12856 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation

Safety and efficacy of a feed additive consisting of ferric citrate chelate (CI-FERTM) for poultry species for fattening or reared up to the point of lay (Akeso Biomedical, Inc.)

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 ferric citrate chelate (CI-FER (TM)) as a zootechnical additive for poultry species for fattening or reared up to the point of lay. The product had been already assessed by the FEEDAP Panel for use in suckling and weaned piglets and minor porcine species. The application was for an extension of use to poultry species for fattening or reared up to the point of lay. The FEEDAP Panel considers that the new use would not raise safety concerns for the consumers and the environment and retained the previous conclusions as regards to the user: CI-FER (TM) does not pose a risk by inhalation, it is non-irritant to the skin but should be considered as an eye irritant and as a skin sensitiser. Owing to the limitations identified in the tolerance trial submitted, the FEEDAP Panel could not conclude on the safety of the additive for the target species. Regarding the efficacy, three studies were submitted but two of them were not considered further in the assessment due to the husbandry conditions to which the animals were subject to. Therefore, the FEEDAP Panel could not conclude on the efficacy of the additive

Safety and efficacy of a feed additive consisting of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 for all animal species (Lactosan GmbH & Co.KG.)

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 an additive consisting of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 x 10(8) colony-forming units (CFU)/kg fresh material. The bacterial species P. freudenreichii and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to assessment. As the identity of the strains has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strains as a silage additive is considered safe for livestock species, for consumers and for the environment. The additive is not irritant for eyes or skin but should be considered a respiratory sensitiser. In the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be a skin sensitiser. The additive at the proposed application rate of 1 x 10(8) CFU/kg fresh plant material showed the potential to improve the aerobic stability silage with dry matter content ranging from 30% to 70%

Safety and efficacy of a feed additive consisting of astaxanthin-rich Phaffia rhodozyma for salmon and trout (Igene Biotechnology, Inc.)

Following a request from the European Commission, the FEEDAP Panel was asked to deliver a scientific opinion on the safety and efficacy of astaxanthin (ATX)-rich Phaffia rhodozyma. The additive, belonging to the category 'sensory additives' and the functional group 'substances which, when fed to animals, add colours to food of animal origin' is intended to be used in feed for salmon and trout from an age of six months onwards up to a maximum content of 100 mg ATX/kg complete feed. The product is produced by the telemorph of Phaffia rhodozyma, Xanthophyllomyces dendrorhous, and it is declared to contain 995 g dried inactivated biomass and 5 g ascorbic acid per kg additive. The main active principle of the additive is ATX; however, the FEEDAP Panel noted that some other carotenoids are also present in lower quantities. The minimum ATX concentration is specified to be 5,000 mg per kg additive. The yeast Xanthophyllomyces dendrorhous is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment; therefore, the use of the production strain in the production of the additive would not raise any safety concern for the target species, the consumers of products from animals fed the additive and the environment. In the absence of a tolerance study with the additive, the FEEDAP Panel cannot conclude on the safety for the target species. In the absence of residue and toxicity data of ATX, no final conclusions on the safety for the consumer can be drawn. The FEEDAP Panel concluded that the additive is irritant to skin and eyes, and a skin and respiratory sensitiser, although exposure by inhalation is likely low. The FEEDAP Panel considers that ATX from the biomass does not pose a significant additional risk to the environment compared with other natural sources of ATX. In absence of adequate evidence, no conclusion can be made on the efficacy of the additive

Efficacy of a feed additive consisting of nicarbazin (Coxar®) for use in turkeys for fattening (Huvepharma N.V.)

Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of the coccidiostat nicarbazin (Coxar(R)) when used in feed for turkeys for fattening. On the basis of the new data provided, the FEEDAP Panel updated its previous conclusions on the efficacy of Coxar(R) as follows: the two new floor pen studies showed efficacy of nicarbazin from Coxar(R) reducing the adverse clinical consequences of an Eimeria infection in turkeys. Overall, when considering also the positive floor pen study previously reported and the three positive anticoccidial sensitivity tests, the FEEDAP Panel concludes that Coxar(R) has the potential to be efficacious against coccidiosis of turkeys for fattening at 100 mg nicarbazin/kg complete feed. (c) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority

Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.)

Amaferm(R) is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm(R) complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm(R) remains safe under the approved conditions for target species, consumers and the environment. The additive is non-irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser

Safety and efficacy of a feed additive consisting of Bacillus velezensis PTA‐6507, B. velezensis NRRL B‐50013 and B. velezensis NRRL B‐50104 (Enviva® PRO 202 GT) for turkeys for fattening (Danisco Animal Nutrition)

[EN]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 the additive consisting of Bacillus amyloliquefaciens PTA-6507, B. amyloliquefaciens NRRL B-50013 and B. amyloliquefaciens NRRL B-50104 (trade name: Enviva® PRO 202 GT) for turkeys for fattening. The product under assessment is based on viable spores of three strains originally identified as B. amyloliquefaciens which, in the course of the current assessment, were reclassified as Bacillus velezensis. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agents was established. The active agents do not harbour acquired antimicrobial resistance genes and lack toxigenic potential and the capacity to produce aminoglycosides. Following the QPS approach, the three bacterial strains are presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, Enviva® PRO 202 GT is also considered safe for the target species, consumers and the environment. Enviva® PRO 202 GT is non-irritant to skin and eyes and is not a dermal sensitiser. Due to the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. In a previous opinion, it was concluded that Enviva® PRO 202 GT has a potential to be efficacious as a zootechnical additive in chickens for fattening at the recommended level of 7.5 × 107 CFU/kg complete feed. It is considered that conclusions on efficacy of Enviva® PRO 202 GT in chickens for fattening can be extrapolated to turkeys for fattening. Therefore, the FEEDAP Panel concludes that Enviva® PRO 202 GT has the potential to be efficacious in turkeys for fattening at 7.5 × 107 CFU/kg complete feed.S

Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.)

[EN] Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non-irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser.SIThe Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last name): Working Group on Animal Nutrition and Working Group on Microbiology, Rosella Brozzi, Christina Cuomo and Jordi Tarres Call