Efficacy of the feed additive containing Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I-3740 (Biacton\uae) for chickens for fattening, turkeys for fattening and laying hens (ChemVet dk 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 efficacy of the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I-3740 (tradename: Biacton\uae) for chickens for fattening, turkeys for fattening and laying hens. The additive is a preparation containing viable cells of C. farciminis CNCM I-3740 at the minimum concentration of 1  7 109 CFU/g additive. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in these target species. The Panel concluded that based on the qualified presumption of safety of the active agent, and the lack of concerns deriving from other components of the additive, Biacton\uae was presumed safe for the target animals, consumers and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive did not allow drawing conclusions on the efficacy of the additive in any of the target species. The additional information submitted with chickens for fattening and laying hens did not provide sufficient evidence to conclude on the efficacy of Biacton\uae for these target species. No new information was provided that would lead the Panel to reconsider the conclusions already reached on the use of the additive with turkeys for fattening. The FEEDAP Panel, based on the available data, cannot conclude on the efficacy of Biacton\uae in chickens for fattening, turkeys for fattening and laying hens

Safety and efficacy of Bonvital® (Enterococcus faeciumDSM 7134) as a feed additive for laying hens

open23siFollowing a request from the European Commission, EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Bonvital® for laying hens. Bonvital® is an additive containing viable cells of Enterococcus faeciumDSM 7134 marketed in two forms, a granular and a powder form, both with a guaranteed minimum concentration of E. faeciumDSM 7134 of 1.0 × 1010 colony forming units (CFU)/g additive. Bonvital® in either form is intended for use in feed for laying hens at the minimum concentration of 1.0 × 109 CFU/kg complete feed and at the maximum concentration of 1.0 × 1010 CFU/kg feedingstuffs. Bonvital powder® is also proposed for use in water for drinking at the minimum concentration of 5.0 × 108 CFU/L. The use of Bonvital® in animal nutrition is considered safe for the target animals. The results of a tolerance trial in which hens were fed the additive at 10-fold the maximum recommended dose support this conclusion. Delivery of comparable doses of the additive via water for drinking is considered as safe for laying hens. Bonvital® at the proposed conditions of use is safe for consumers of products derived from animals fed the additive and for the environment. Bonvital® is not a dermal or ocular irritant but a potential dermal and respiratory sensitiser. Bonvital® has the potential to be efficacious in improving the hen's performance when supplemented at 1.0 × 109 CFU/kg feed or 5.0 × 108 CFU/L water for drinking.openBampidis V.; Azimonti G.; Bastos M.; Christensen H.; Dusemund B.; Kouba M.; Fasmon Durjava M.; Lopez-Alonso M.; Lopez Puente S.; Marcon F.; Mayo B.; Pechova A.; Petkova M.; Ramos F.; Sanz Y.; Villa R.; Woutersen R.; Dierick N.; Martelli G.; Anguita M.; Galobart J.; Revez J.; Brozzi R.Bampidis V.; Azimonti G.; Bastos M.; Christensen H.; Dusemund B.; Kouba M.; Fasmon Durjava M.; Lopez-Alonso M.; Lopez Puente S.; Marcon F.; Mayo B.; Pechova A.; Petkova M.; Ramos F.; Sanz Y.; Villa R.; Woutersen R.; Dierick N.; Martelli G.; Anguita M.; Galobart J.; Revez J.; Brozzi R

Safety and efficacy of a feed additive consisting of 3-phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 3-phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) as a zootechnical additive for poultry species, pigs for fattening and minor porcine species. The production strain (CECT 13171) is genetically modified and was developed from a strain that had been previously assessed by the FEEDAP Panel. The genetic modifications present in K. phaffii CECT 13171 do not raise safety concerns and no recombinant DNA was detected in the final formulations of the additive (FSF10000/FLF1000). However, the Panel could not conclude on the identity of the production strain and uncertainty remained on the possible presence of viable cells of the production strain in the final formulations. Owing to these uncertainties, the FEEDAP Panel could not conclude on the safety of the additive regarding the production strain. The additive in either form is not irritant to eyes and skin, the liquid formulation is not a dermal sensitiser but the solid formulation is, and the two formulations should be considered potential respiratory sensitisers. The FEEDAP Panel concluded that the 3-phytase present in the additive is safe for the target species at a level of 1,000 FTU/kg feed and that would not raise safety concerns for the environment. However, considering the uncertainties on the identification of the production strain and the possible presence of viable cells in the final formulations, the Panel could not conclude on the safety of the additive for the target species, consumer, users, and the environment. The FEEDAP Panel concluded that the additive is efficacious at 500 FTU/kg feed in poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species and at 1,000 FTU/kg feed in laying hens

Safety and efficacy of a feed additive consisting of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO® ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO® ADVANCE (liquid and solid) which contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The enzymes present in the additive are produced by two strains of Talaromyces versatilis, one of them genetically modified. The additive is intended to be used as a feed additive for weaned piglets and pigs for fattening. Viable cells of the production strains and DNA of the genetically modified strain were not detected in the fermentation product used to formulate the additive. Based on the results of a tolerance trial in weaned piglets, the FEEDAP Panel concluded that ROVABIO® ADVANCE is safe for weaned piglets under the recommended conditions of use. This conclusion was extended to pigs for fattening. Based on the outcome of the toxicological studies performed, the Panel concluded that the additive is of no concern regarding consumer safety. ROVABIO® ADVANCE is not irritant to the skin or eyes but it is a skin and respiratory sensitiser. No risks to the environment are expected from the use of the additive in animal nutrition. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of ROVABIO® ADVANCE

Safety and efficacy of a feed additive consisting of disodium 5’-guanylate produced with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067 for all animal species (CJ Europe GmbH)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5’-guanylate produced by fermentation with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The additive does not raise safety concerns under the proposed conditions of use for the target species, consumers the users and the environment. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) expressed reservations on the use of the additive in water for drinking due to concerns on its impact on hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed

Safety and efficacy of a feed additive consisting of Bifidobacterium longum CNCM I-5642 (PP102I) for cats and dogs (Nestlé Enterprises S.A.)

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 Bifidobacterium longum CNCM I-5642 (PP102I) when used as a feed additive for cats and dogs. The product under assessment consists of viable cells of a strain of B. longum, a species considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The strain was unambiguously identified as B. longum and was shown not to harbour antimicrobial resistance determinants for antibiotics of human and veterinary importance, thus meeting the QPS requirements. Following the QPS approach to safety assessment and since no concerns are expected from maltodextrin, the other component of the additive, PP102I was considered safe for the target species and the environment. Owing to the lack of data, no conclusions could be drawn on the skin/eye irritancy potential of PP102I. However, it should be considered a skin and respiratory sensitiser. The Panel was not in the position to conclude on the efficacy of PP102I for the target species

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. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 15 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 12 compounds, read-across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 12 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer from the use of the 27 compounds up to the highest levels considered safe for target animals. No new data were submitted on the safety for the user that would allow the FEEDAP Panel to change its previous conclusion for 5-methylhept-2-en-4-one [07.139], 5-methylfurfural [13.001] and 4-phenylbut-3-en-2-one [07.024]. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by Komagataella phaffii DSM 33574, and viable spores of Bacillus velezensis DSM 21836 and Bacillus licheniformis ATCC 53757 (EnzaPro) for chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and growing minor poultry species (BioResource International (BRI), Inc.)

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 the product EnzaPro containing viable cells/spores of strains of Bacillus velezensis (DSM 21836) and Bacillus licheniformis (ATCC 53757) and an endo-1,4-β-xylanase produced by a genetically modified strain of Komagataella phaffii (DSM 33574) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. The strains B. velezensis DSM 21836 and B. licheniformis ATCC 53757 were considered to meet the qualified presumption of safety (QPS) requirements. The K. phaffii xylanase production strain is genetically modified. No viable cells and no recombinant DNA of the genetically modified production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the xylanase production strain. EnzaPro is safe for all poultry species for fattening or reared to the point of lay at the proposed conditions of use. The FEEDAP Panel concluded that the use of EnzaPro in animal nutrition is safe for the consumers and the environment. EnzaPro is not a skin irritant but should be considered an eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. Due to the lack of data, the FEEDAP Panel could not conclude on the efficacy of EnzaPro for the target species. EnzaPro is compatible with diclazuril, halofuginone and nicarbazin

Safety and efficacy of the additive consisting of muramidase produced by Trichoderma reesei DSM 32338 (Balancius™) for use in weaned piglets (DSM Nutritional products 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 muramidase produced by Trichoderma reesei DSM 32338 (Balancius™) as a feed additive for weaned piglets. The additive has been previously assessed by the FEEDAP Panel in the context of other applications, and in the current assessment the applicant requests for an extension of use. Based on the data available in a sub-chronic oral toxicity study, the Panel concluded that the additive is safe for weaned piglets at the maximum recommended level of 65,000 LSU(F)/kg feed. The additive is safe for the consumers and the environment but should be considered a potential respiratory sensitiser. The Panel could not conclude on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive has the potential to be efficacious as a zootechnical additive for weaned piglets at the dose of 50,000 LSU(F)/kg feed

Safety and efficacy of a feed additive consisting of 6-phytase produced by Trichoderma reesei CBS 146250 (Axtra® PHY GOLD 30L, Axtra® PHY GOLD 30T, Axtra® PHY GOLD 65G) for all poultry species and all pigs (Danisco (UK) ltd)

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 6-phytase produced by the genetically modified strain Trichoderma reesei CBS 146250 (Axtra® PHY GOLD 30L, Axtra® PHY GOLD 30 T and Axtra® PHY GOLD 65G) as a zootechnical feed additive for all poultry species and all pigs. The FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry species and all pigs at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not give rise to concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel cannot conclude on the potential of the additive to be irritant to eyes or skin. Due to the proteinaceous nature of the active substance, it is considered a respiratory sensitiser. The panel concludes that the additive is efficacious in increasing the phosphorus utilisation when supplemented at 500 FTU/kg for all growing poultry species and all pigs, and at 300 FTU/kg in laying hens and other laying birds