Safety for the environment of a feed additive consisting of semduramicin sodium (Aviax 5%) for chickens for fattening (Phibro Animal Health s.a.).

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 for the environment of the coccidiostat semduramicin sodium (Aviax 5%) when used in feed for chickens for fattening. The additive Aviax 5% is intended to be used as a coccidiostat in feed for chickens for fattening at a level of 20-25 mg semduramicin sodium/ kg complete feed. The safety and efficacy of the additive was evaluated by the FEEDAP Panel in 2018 and 2022. In those opinions it was concluded that the additive is safe for the target species and consumer, while no conclusions could be made on the irritancy of Aviax 5% to skin and eye and on the potential for dermal and respiratory sensitisation. Regarding the safety for the environment, the Panel concluded that a risk for the terrestrial compartment could not be excluded. Based on new data submitted, no risk is expected from the use of the additive in animal nutrition at the proposed conditions of use for the terrestrial compartment. The previous conclusions of the FEEDAP Panel on the safety of the additive for the environment can be updated as follows: the use of semduramicin sodium from Aviax 5% in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for groundwater nor for aquatic, terrestrial and sediment compartments.

Safety and efficacy of a feed additive consisting of Enterococcus faecium NBIMCC 8270, Lactobacillus acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp. lactis NBIMCC 8250, L. delbrueckii ssp. bulgaricus NBIMCC 8244 and Streptococcus thermophilus NBIMCC 8253 (Probiotic Lactina®) for cats and dogs (Lactina 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 and efficacy of the feed additive consisting of Enterococcus faecium NBIMCC 8270, Lactobacillus acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp. lactis NBIMCC 8250, L. delbrueckii ssp. bulgaricus NBIMCC 8244 and Streptococcus thermophilus NBIMCC 8253 (Probiotic Lactina®) when used as a zootechnical additive for cats and dogs. The Panel concluded that Probiotic Lactina® is safe for the target species at the proposed conditions of use. The Panel also concluded that Probiotic Lactina® is irritant to skin and eyes and a respiratory sensitiser, but in the absence of data, no conclusions could be reached on its skin sensitisation potential. No conclusions could be drawn on the efficacy of Probiotic Lactina® for dogs and cats based on the data available.

Safety and efficacy of a feed additive consisting of Pediococcus acidilacticiCNCM I-4622 for all animal species (Danstar Ferment AG).

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 Pediococcus acidilactici CNCM I-4622 when used as a technological additive (acidity regulator and hygiene condition enhancers) for all animal species. The product is intended for use in mash compound feeds and/or solid feed materials used for the preparation of liquid feeds at a minimum inclusion level of 1 × 109 CFU kg feed. The bacterial species is considered by EFSA to be eligible for the qualified presumption of safety (QPS) approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of this strain in animal nutrition is considered safe for the target species, consumers and the environment. The additive is considered to be a respiratory sensitiser but is not irritant to eyes/skin or a skin sensitiser. Pediococcus acidilactici CNCM I-4622 at 1 × 109 CFU/kg complete feed showed the potential to reduce the pH and the growth of coliforms in liquid feeds. Pediococcus acidilactici CNCM I-4622 is compatible with halofuginone, diclazuril, decoquinate and nicarbazin at the highest authorised levels for chickens for fattening.

Safety and efficacy of a feed additive consisting of endo-1,4-ß-xylanase produced by Komagataella phaffii ATCC PTA-127053 (Xygest™ HT) for poultry (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 endo-1,4-ß-xylanase produced by Komagataella phaffii ATCC PTA-127053 (Xygest™ HT) as a zootechnical feed additive for poultry. The production strain is genetically modified. No viable cells nor recombinant DNA of the production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the production strain. The FEEDAP Panel concluded that Xygest™ HT is considered safe for chickens for fattening at 30,000 U/kg and in laying hens at 45,000 U/kg, with a wide margin of safety. These conclusions can be extended to chickens reared for laying/breeding and extrapolated to all poultry species for fattening and reared for laying/breeding and to ornamental birds. The conclusions on laying hens are extrapolated to all laying poultry species. The use of Xygest™ HT in animal nutrition is of no concern for consumer safety and this feed additive is considered safe for the environment. The Panel also concluded that Xygest™ HT is not irritant to the eyes and skin but should be considered a dermal and a respiratory sensitiser. The Panel concluded that the additive Xygest™ HT has a potential to be efficacious for laying hens under the proposed conditions of use and this conclusion can also be extrapolated to all laying poultry species. The Panel could not conclude on the efficacy of the product for chickens for fattening due to insufficient data.

Safety and efficacy of a feed additive consisting of Pediococcus pentosaceus DSM 32292 for all animal species (Marigot Ltd t/a Celtic Sea Minerals).

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 Pediococcus pentosaceus DSM 32292 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 5 × 107 colony forming units (CFU)/kg forage. The bacterial species P. pentosaceus is considered by EFSA to be suitable for the qualified presumption of safety (QPS) 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 5 × 107 CFU/kg forage has the potential to improve the production of silages from moderately difficult to ensile forages.

Safety and efficacy of Correlink™ ABS1781 Bacillus subtilis (Bacillus velezensisNRRL B-67259) as a feed additive for all growing poultry species.

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 Correlink™ ABS1781 Bacillus subtilis (hereafter designated as Correlink™ ABS1781) when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and minor growing poultry species. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis, which in the course of the current assessment, was reclassified as Bacillus velezensis NRRL B-67259. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NRRL B-67259 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Correlink™ ABS1781 is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. Correlink™ ABS1781 is not irritant to skin and eyes or a skin sensitiser but is a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of Correlink™ ABS1781 for the target species due to lack of data.