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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application of renewal of Limosilactobacillus fermentum NCIMB 30169 as a technological feed additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers, and the environment. Regarding user safety, the additive should be considered a skin and respiratory sensitiser. No conclusions can be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lentilactobacillus buchneri ATCC PTA‐6138 as a technological additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the additive should be considered as a skin and respiratory sensitiser. No conclusions could be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lentilactobacillus buchneri ATCC PTA‐2494 as a technological additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the Panel considers that any exposure through skin and respiratory tract is considered a risk. The Panel cannot conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 Trichoderma reesei. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the genetic modification of the production strain does not give rise to safety concerns; viable cells of the production strain and its DNA were not detected in the final products. The FEEDAP Panel concluded that, based on the data available, the additive tested is safe for fin fish at the highest recommended level of 2500 phytase activity unit (FTU)/kg complete feed. The Panel concluded that Quantum® Blue is not an irritant to skin and eyes nor a skin sensitiser. Owing to the proteinaceous nature of the active substance, 6‐phytase (Quantum® Blue) is considered a respiratory sensitiser. The use of Quantum® Blue as a feed additive is considered safe for the environment. The additive is considered to be efficacious as a zootechnical additive for salmonids and ornamental fish at 500 FTU/kg complete feed and other fin fish at 2500 FTU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Levilactobacillus brevis (formerly Lactobacillus brevis) DSM 23231 as a technological feed additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that evidence has been provided that the additive currently on the market complies with the existing terms of authorisation. The Panel also concluded that L. brevis DSM 23231 remains safe for all animal species, consumers and the environment under the authorised conditions of use. The additive should be considered a respiratory sensitiser. Based on the studies submitted regarding user safety, the preparation of the additive tested was shown not to be a skin or eye irritant. The Panel was not in the position to conclude on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive for weaned piglets, calves for fattening and calves for rearing. The product under assessment is based on a strain originally identified as Enterococcus faecium. During the current assessment, the active agent has been reclassified as Enterococcus lactis. The additive currently authorised is marketed in two formulations: Lactiferm Basic 50 (a solid formulation to be used in feed), and Lactiferm WS200 (a solid ‘water‐soluble’ formulation to be used in water for drinking). The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concludes that the use of Lactiferm® under the authorised conditions of use remains safe for the target species (calves up to 6 months and weaned piglets up to 35 kg), consumers and the environment. The Lactiferm WS200 formulation of the additive is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It is not possible to conclude on the irritating potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both forms of the additive to cause skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 Lactiplantibacillus plantarum (previously Lactobacillus plantarum) NCIMB 30083 as a technological additive, silage additive 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 that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation, and skin and eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat monensin sodium (Elancoban® G200) when used as a feed additive for chickens for fattening and turkeys. Based on the new data provided, the Panel updates its previous conclusions as follows: monensin sodium is produced by fermentation by a non‐genetically modified strain of Streptomyces sp. NRRL B‐67924. Genome analysis suggests the production strain may belong to a new species within the genus Streptomyces. The production strain and its DNA were not detected in the final additive. The product is free of antimicrobial activity other than monensin. The FEEDAP Panel cannot conclude on the safety of monensin sodium from Elancoban® G200 in feed for chickens for fattening and chickens reared for laying at the proposed maximum use level due to a dose‐related reduction of the final body weight. The toxicological profile of monensin sodium was evaluated in studies made with the product obtained from the parental strain ATCC 15413. Based on a comparison of the genomes of the two strains, the FEEDAP Panel concludes that toxicological equivalence has been established, thus the conclusions already drawn on Elancoban® G200 are valid for the product obtained with the new production strain concluding that the additive is safe for the consumer and the environment; the production strain does not represent an additional risk when safety for the user is considered. Monensin sodium from Elancoban® G200 is safe for turkeys up to 16 weeks of age at the concentration of 100 mg monensin sodium/kg feed and has the potential to control coccidiosis at the minimum concentration of 60 mg/kg complete feed.

Abstract 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 Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis 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. Moreover, the Panel could not conclude on the efficacy in laying hens. The applicant submitted some new information to address some of the limitations previously identified. Moreover, the applicant declared a change in the production strain of the protease, substituting B. subtilis ATCC SD‐2107 for B. subtilis CBS 148232. The Panel concluded that the additive is safe for the target species at the recommended use level (1,000 xylanase U, 100 amylase U and 2,000 protease U per kg feed). The additive is safe for the consumers of food products obtained from animals fed with the additive and raises no concerns for the environment. The Panel could not conclude on the skin/eye irritancy potential of the additive nor on its dermal sensitisation potential. Owing to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level). Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens.

Abstract 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 assessment of the application for renewal of Lactiplantibacillus plantarum ssp. plantarum (formerly Lactobacillus plantarum ssp. plantarum) DSM 8862 and Lactiplantibacillus plantarum ssp. argentoratensis (formerly Lactobacillus plantarum ssp. argentoratensis) DSM 8866 as a technological additive to improve ensiling of forage for all animal species. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not a skin irritant but no conclusions can be drawn on the eye irritancy potential of the additive nor to the skin sensitisation potential. The additive should be considered a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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.

Abstract 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.

Abstract 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.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactococcus lactis NCIMB 30117 as a technological additive for use in forage for all animal species. The additive aims to improve 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 new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation, and eye and skin irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactococcus lactis DSM 11037, 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. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not a skin and eye irritant but should be considered a respiratory sensitiser. In absence of data, the Panel cannot conclude on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lacticaseibacillus rhamnosus (formerly Lactobacillus rhamnosus) NCIMB 30121 as a technological additive for all animal species. The additive aims to improve the production of silage and is authorised without a minimum inclusion level. The applicant provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered a skin and respiratory sensitiser. No conclusions could be drawn on the eye and skin irritancy potential of the additive. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 Lacticaseibacillus paracasei (formerly Lactobacillus paracasei) DSM 16245 as a technological additive for all animal species. The additive aims to improve the production of silage and is currently authorised at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety L. paracasei DSM 16245 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser.

Abstract 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 preparation of Bacillus subtilis CNCM I‐4606, B. subtilis CNCM I‐5043, B. subtilis CNCM I‐4607 and Lactococcus lactis CNCM I‐4609 when used as a technological additive (hygiene condition enhancer) for all animal species. The product is intended for use in compound feeds and feed materials for all animal species at a minimum inclusion level of 1 × 109 CFU B. subtilis and 1 × 109 CFU L. lactis per kg or litre. The two bacterial species are considered by EFSA to be eligible for the qualified presumption of safety (QPS) approach. As the identity of the strains has been clearly established and they did not show acquired resistance to antibiotics of human and veterinary importance, the use of these strains in animal nutrition is considered safe for the target species, consumers and the environment. The additive is not irritant to skin and eyes or a skin sensitiser. Given the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of the additive to significantly reduce the growth of either Salmonella Typhimurium or Escherichia coli in feed.

Abstract 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 Levilactobacillus brevis (formerly Lactobacillus brevis) DSM 12835 as a technological additive for all animal species. The additive aims to improve the production of silage and is authorised without a minimum inclusion level. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, L. brevis DSM 12835 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.

Abstract 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) DSM 26571 when used as a technological additive intended to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed application rate of 1 × 108 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 to safety assessment. As the identity of the strain has been clearly established and no acquired 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. The additive is not irritant to skin or eyes and is not a skin sensitiser but should be considered a potential respiratory sensitiser. The FEEDAP Panel concluded that the addition of Lactiplantibacillus plantarum DSM 26571 at a minimum concentration of 1 × 108 CFU/kg may improve the production of silage from easy, moderately difficult and difficult to ensile forage material.

Abstract 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 16774 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 evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety Lentilactobacillus buchneri DSM 16774 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 IMI 507025 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 P. pentosaceus is considered by the European Food Safety Authority 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.

Abstract 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.

Abstract 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 the authorisation of Pediococcus pentosaceus DSM 12834 as a technological additive 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 that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety Pediococcus pentosaceus DSM 12834 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 Lacticaseibacillus rhamnosus (formerly Lactobacillus rhamnosus) IMI 507023 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. rhamnosus 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 acquired 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.

Abstract 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 Pediococcus acidilactici DSM 16243 as a technological additive 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 that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety Pediococcus acidilactici DSM 16243 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 extension of use of the feed additive consisting of Bacillus velezensis CECT 5940 (tradename: Ecobiol®) to turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (except for reproduction). The product under assessment is based on viable spores of a strain originally identified as Bacillus amyloliquefaciens. During the course of the current assessment, the active agent has been reclassified as B. velezensis CECT 5940. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach. The identity of the active agent was established and the compliance with the other qualifications confirmed. Therefore, B. velezensis CECT 5940 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, the additive Ecobiol® is also considered safe for the target species, consumers and the environment. The additive is not irritant to skin/eye or a skin sensitiser, but should be considered a respiratory sensitiser. The efficacy data previously evaluated allowed the Panel to conclude that the additive has the potential to be efficacious at the level of 1 × 109 CFU/kg feed in turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (except for reproduction).

Abstract 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 four bacteriophages infecting Salmonella Gallinarum B/00111 (PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097, trade name: Bafasal®) when used as a zootechnical additive in water for drinking and liquid complementary feed for all avian species. The effects sought are the reduction of the Salmonella spp. carriage in chickens for fattening, the improvement of their performance, or both. The host strain harbours an acquired antimicrobial resistance gene. No viable cells or DNA from the host organism were found in the additive. The four phages proved to be strictly lytic and to have a machinery allowing to package a unit‐length of the viral genome. The manufacturing process excludes the presence of remnants from the propagation process in the final additive. Consequently, no concerns are expected from the nature and manufacture of the product. Considering this and the results of the tolerance study with chickens for fattening, the Panel concluded that Bafasal® is safe for all avian species. Considering the nature and manufacturing process of the additive, Bafasal® is not expected to pose a risk for consumers. The results of the subchronic oral toxicity study and genotoxicity studies provided support this conclusion. Exposure of users via inhalation is expected to be low, but Bafasal® should be considered a respiratory sensitiser. No conclusions were drawn on the irritancy of Bafasal® to skin and eyes or on its dermal sensitisation potential due to lack of data. Considering the nature and manufacturing process of the additive, Bafasal® is safe for the environment. The Panel was not in the position to conclude on the efficacy of Bafasal® for any avian species due to insufficient data.

Abstract 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 Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 21762, as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but is considered a skin and respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ECONASE® XT (endo‐1,4‐β‐xylanase) produced by a genetically modified strain of Trichoderma reesei (CBS 140027) as a zootechnical feed additive for piglets (weaned), pigs for fattening, chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding and minor poultry species. The recipient strain and the production strain T. reesei CBS 140027 are considered safe. The additive is safe for chickens for fattening and weaned piglets at the maximum recommended doses (16,000 and 24,000 BXU/kg feed, respectively) with a wide margin of safety (100‐fold and 50‐fold, respectively). These conclusions are extended to chickens reared for laying and to pigs for fattening at 16,000 and 24,000 BXU/kg feed, respectively. The additive is safe for turkeys for fattening or reared for breeding at 16,000 BXU/kg feed. The FEEDAP Panel cannot conclude on the safety of the additive for laying hens and for minor poultry species for laying at the proposed conditions of use. The information provided does not allow to conclude on the safety of the use of ECONASE XT® P/L produced by T. reesei CBS 140027 in animal nutrition for the consumers. The use of the additive under assessment in animal nutrition does not raise safety concerns for the environment. ECONASE® XT L is non‐irritant to the skin or to the eyes. In absence of data, the FEEDAP Panel cannot conclude on the potential of the solid product to be irritant to skin and eyes and on the potential of the additive in all forms to be a dermal sensitiser. All forms of the additive should be considered as respiratory sensitisers. All forms of the additive are considered efficacious at the minimum recommended levels for the target species.

Abstract 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 l‐valine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (CGMCC 7.366). The additive is intended to be used in feed and water for drinking for all animal species and categories. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concludes that l‐valine produced using C. glutamicum CGMCC 7.366 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of l‐valine produced using C. glutamicum CGMCC 7.366 in animal nutrition is considered safe for the consumer and for the environment. No conclusion could be drawn on the potential of l‐valine produced using C. glutamicum CGMCC 7.366 to be toxic by inhalation, irritant to the skin or eyes, or a dermal sensitiser due to the lack of data. The additive l‐valine produced by fermentation using C. glutamicum CGMCC 7.366 is regarded as an efficacious source of the essential amino acid l‐valine for non‐ruminant nutrition. For the supplemental l‐valine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

Abstract 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.

Abstract 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 the additive consisting of Enterococcus faecium DSM 7134 (trade name: Bonvital®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening. The additive is produced in powder and granulate (microencapsulated) forms. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of Bonvital® under the current authorised conditions of use is safe for the target species, the consumers and the environment. Bonvital® is not irritant to skin and eyes but should be considered a potential skin sensitiser and a respiratory sensitiser. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation. The FEEDAP Panel reiterates its previous conclusions that E. faecium DSM 7134 is compatible with the coccidiostats robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium.

Abstract 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 Bacillus licheniformis DSM 28710 (trade name: B‐Act®) when used in feed for laying hens, minor poultry species for laying and for breeding purposes and ornamental birds. B. licheniformis 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 or has toxigenic potential. Following the QPS approach, B. licheniformis DSM 28710 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, B‐Act® is also considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B‐Act® is considered a respiratory sensitiser. B‐Act® when supplemented at 1.6 × 109 CFU/kg complete feed has the potential to be efficacious in laying hens. Considering also that the efficacy of the product was already shown in chickens and turkeys for fattening, the Panel concludes that the additive has the potential to be efficacious in minor poultry species for laying, poultry species for breeding purposes and for ornamental birds at the same inclusion level. The conclusions on the compatibility of B‐Act® with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal or lower than those for chickens.

Abstract Ronozyme® ProAct is the trade name of the feed additive under assessment and contains serine protease produced by a genetically modified strain of Bacillus licheniformis. 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 Ronozyme® ProAct when used as a zootechnical additive for chickens for fattening. The additive is available in coated thermotolerant granulated and liquid forms (Ronozyme® ProAct CT/L). The production strain and its recombinant DNA were not detected in an intermediate concentrated product used to produce the final formulations. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the FEEDAP Panel concluded that the additive is safe for chickens for fattening. The FEEDAP Panel concluded that the use of Ronozyme® ProAct CT/L as a feed additive gives rise to no concern for consumers and for the environment. The additive, in either form, is not an eye irritant but should be considered a skin irritant. In the absence of data, no conclusions on the skin sensitisation potential can be reached. Owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The FEEDAP Panel also concluded that the additive has the potential to be efficacious at 15,000 PROT/kg compound feed for chickens for fattening.

Abstract 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 l‐tryptophan produced by fermentation with Escherichia coli KCCM 80210 when used as a nutritional additive in feed for all animal species and categories. The production strain E. coli KCCM 80210 is safe for the production of l‐tryptophan and it was not detected in the final product. The Panel notes that two out of five batches of the additive do not comply with the minimum specification of 98% l‐tryptophan on a dry matter basis proposed by the applicant. The use of l‐tryptophan (≥ 98%) produced by E. coli KCCM 80210 in supplementing feed to compensate for l‐tryptophan deficiency in feedingstuffs is safe for non‐ruminant target species. There may be a risk for an increased production of toxic metabolites when unprotected l‐tryptophan is used in ruminants. The use of l‐tryptophan produced by E. coli KCCM 80210 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. The additive under assessment is considered a mild eye irritant. The endotoxin activity of the additive and its dusting potential indicate a risk by inhalation for the users. The additive is not a skin irritant and is not a skin sensitiser. The additive l‐tryptophan is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. In order to be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation.

Abstract 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 additive consisting of Ligilactobacillus animalis (formerly known as Lactobacillus animalis) ATCC PTA‐6750 when used as a technological additive (acidity regulator, preservative and hygiene condition enhancer) in feed and water for drinking for all animal species. The product is intended for use as a single strain at a minimum inclusion level of 5 × 106 CFU/L or CFU/kg in water, liquid and dry feeds. No minimum inclusion level is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species L. animalis is considered by EFSA to be eligible for the qualified presumption of safety 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 the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. The Panel is not in the position to conclude on the efficacy of L. animalis ATCC PTA‐6750 when used in animal nutrition as an acidity regulator, preservative or hygiene condition enhancer due to lack of data. The studies provided showed that L. animalis ATCC PTA‐6750 when used in combination with Propionibacterium freudenreichii ssp. shermanii ATCC PTA‐6752 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditions.

Abstract 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 additive consisting of Propionibacterium freudenreichii ssp. shermanii ATCC PTA‐6752 when used as technological additive (acidity regulator) in dry feed at a minimum inclusion level of 2 × 109 colony‐forming units (CFU)/kg and in complete or complementary liquid feed for all animal species at a minimum concentration of 1 × 109 CFU/L. No minimum concentration is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species P. freudenreichii is considered by EFSA to be eligible for the qualified presumption of safety approach to safety assessment. 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 the strain in animal nutrition is considered safe for the target animals, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the additive, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. No conclusions could be drawn on the efficacy of the additive when used alone as an acidity regulator in feed due to lack of data. The studies provided showed that P. freudenreichii ssp. shermanii ATCC PTA‐6752 when used in combination with Ligilactobacillus animalis ATCC PTA‐6750 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditions.

Abstract 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 Vitamin B2/Riboflavin produced by Eremothecium ashbyi CCTCCM 2019833 for all animal species and categories. The additive contains a minimum content of riboflavin of 5%. The production strain has been characterised and data showed that viable cells are not present in the final additive. The additive is not a skin or eye irritant nor a skin sensitiser, but it is considered to be a respiratory sensitiser. The lack of data on the toxicological profile of the additive, including its genotoxic potential, did not allow the Panel to conclude on the safety of the additive for the target species, consumers and users. The FEEDAP Panel concluded that the use of the product as a feed additive poses no concerns for the environment. The additive under assessment is effective in covering the animals’ requirements for vitamin B2 when administered via feed.

Abstract 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.

Abstract 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 ECONASE® XT, an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei CBS 114044. The additive is currently authorised for use in chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, minor poultry species, piglets (weaned) and pigs for fattening. ECONASE® XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. In a previous opinion, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches of the additive. The applicant has submitted data to support the absence of recombinant DNA derived from the production organism in recent product batches. The FEEDAP Panel confirms that the data provided support the absence of recombinant DNA of Trichoderma reesei CBS 114044 in the additive and thus, no safety concern was identified.

Abstract 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 l‐threonine produced by fermentation when used as a nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l‐threonine produced using a genetically modified strain of E. coliCGMCC 13325. The Panel notes that three out of five batches of the additive do not comply with the minimum specification of 98.5% l‐threonine on a dry matter basis proposed by the applicant. The production strain and its DNA were not detected in the final additive. Therefore, the final product does not give raise to any safety concern regarding the genetic modification of the production strain. The use of l‐threonine produced using E. coliCGMCC 13325 in supplementing feed to compensate for threonine deficiency in feedingstuffs is safe for the target species. The FEEDAP Panel identified risks of nutritional imbalances and hygienic concerns for amino acids when administered simultaneously in feed and in water for drinking. The use of l‐threonine produced by fermentation using E. coliCGMCC 13325 in animal nutrition is considered safe for the consumers and for the environment. There is a risk from the inhalation exposure to endotoxins for persons handling the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l‐threonine produced using E. coliCGMCC 13325 to be a skin or eye irritant or a skin sensitiser. The additive under assessment is regarded as an effective source of the amino acid l‐threonine for all non‐ruminant species. For the supplemental l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

Abstract The vitamin B12 (in the form of cyanocobalamin) under assessment is produced by fermentation with a genetically modified strain of Ensifer adhaerens and it is intended to be used as a nutritional additive for all animal species. In 2018, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers and the environment due to uncertainties on the safety of the production strain and the resulting product. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, the additive was considered to pose a risk to user safety. The applicant provided supplementary data on the identity of the production strain, its susceptibility to antibiotics and toxigenic potential, as well as on the absence of cells and recombinant DNA of the production strain in the final product. The production strain is not expected to produce any toxic compound during fermentation but harbours antimicrobial resistance genes. However, viable cells and recombinant DNA of the strain were not detected in the most concentrated form of the additive. With this new information, the FEEDAP Panel concluded that vitamin B12 produced by E. adhaerensCNCM I‐5541 (identified as SCM 2034 in the previous opinion) is safe for all animal species, the consumers and the environment. The applicant did not provide new evidence that would lead the FEEDAP Panel to reconsider previous conclusions regarding the safety for the user.

Abstract 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 6‐phytase produced by Trichoderma reeseiCBS 122001 (brand name: Finase®EC). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel concludes that the additive remains safe for poultry for fattening, breeding and laying, and all pigs, the consumer and the environment under the authorised conditions of use. Regarding user safety, the Panel reiterates that the additive is not a skin or eye irritant or sensitiser but should be considered a potential respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. These conclusions also apply to the new proposed liquid formulation Finase®EC 5 L.

Abstract 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 concentrated liquid l‐lysine (base, minimum 50%) and l‐lysine monohydrochloride (HCl, minimum 99%) produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (KCCM 80216) as nutritional additives for all animal species. Neither the production strain nor its recombinant DNA was detected in the final products. The additives do not pose any safety concern associated with the genetic modification of the production strain. Concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicumKCCM 80216 do not represent a risk for the target species, the consumer and the environment. From the results of studies on the safety for the user of concentrated liquid l‐lysine (base) and l‐lysine HCl produced by a different production strain, it was possible to conclude on the safety for the user of the products under assessment. The concentrated liquid l‐lysine (base) and the l‐lysine HCl are not irritant to skin or eyes or skin sensitiser. l‐lysine HCl is not hazardous by inhalation. l‐lysine HCl and concentrated liquid l‐lysine (base) are considered as efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

Abstract Natugrain® TS/TS L is the trade name of the feed additive under assessment and contains endo‐1,4‐β‐xylanase and endo‐1,4‐β‐glucanase produced by genetically modified strains of Aspergillus niger. The product is currently authorised for use as a feed additive for poultry species, ornamental birds, weaned piglets and pigs for fattening. This scientific opinion concerns the renewal of the authorisation of this additive for poultry species, ornamental birds and weaned piglets. The applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment under the authorised conditions of use. The additive is safe for the target species for which the renewal of the authorisation is requested, the consumers and the environment. The additive is a potential skin and a respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 for the target animals, consumer, user and the environment and on the efficacy of a concentrated liquid l‐lysine (base, minimum 50%) and a l‐lysine monohydrochloride (HCl, minimum 99%) produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (KCTC 12307BP). Both forms of l‐lysine are intended to be used in feed for all animal species and categories. Neither the production strain nor its recombinant DNA were detected in the final products. The additives do not pose any safety concern associated with the genetic modification of the production strain. Concentrated liquid l‐lysine (base) and l‐lysine HCl produced by the strain C. glutamicumKCTC 12307BP do not represent a risk for the target species, for the consumer, for the user and for the environment. l‐Lysine HCl and concentrated liquid l‐lysine (base) are considered to be efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

Abstract 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 concentrated liquid l‐lysine (base) and l‐lysine monohydrochloride (HCl) produced using Corynebacterium caseiKCCM 80190 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l‐lysine. The production strain is genetically modified. It does not carry acquired antimicrobial resistance genes and no viable cells of the production strain nor its DNA were detected in the final products. Therefore, the additives do not pose any safety concern regarding the genetic modifications. Concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. caseiKCCM 80190 do not represent a risk for the target species, the consumer and the environment. From the results of studies on the safety for the user of concentrated liquid l‐lysine (base) and l‐lysine HCl produced by a different production strain, it was possible to conclude on the safety for the user of the products under assessment. Concentrated liquid l‐lysine (base) produced by C. caseiKCCM 80190 is considered hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l‐Lysine HCl produced by C. caseiKCCM 80190 is considered hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. Concentrated liquid l‐lysine (base) and l‐lysine HCl are considered efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

Abstract Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.

Abstract 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 Calsporin® (Bacillus velezensisDSM 15544) as a zootechnical additive for weaned piglets. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis. During the course of the current assessment, the active agent has been reclassified as Bacillus velezensisDSM 15544. 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 the compliance with the other qualifications confirmed. Therefore, B. velezensisDSM 15544 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, Calsporin® is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. The additive is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.