Assessment of the feed additive consisting of Lentilactobacillus buchneriATCC PTA-6138 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

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.

Assessment of the feed additive consisting of Lentilactobacillus buchneriATCC PTA-2494 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

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.

Assessment of the feed additive consisting of Lacticaseibacillus paracasei ATCC PTA-6135 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Lacticaseibacillus paracasei ATCC PTA-6135 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the active agent L. paracasei ATCC PTA-6135 remains safe for all animal species, consumers and the environment. Regarding user safety, the panel concluded that owing to the nature of the additive, L. paracasei ATCC PTA-6135 should be considered a potential skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. In the absence of data, no conclusion could be drawn on the eye irritation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DSM 34246 as a zootechnical feed additive for dogs and cats. The additive, with the trade name Canobios-BL, is intended for use in feed for cats and dogs at a proposed minimum inclusion level of 5 × 109 CFU/kg complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and the additive is composed by dried cells of the active agent and an emulsifier, that are not expected to introduce any risk, the additive is considered safe for the target species. Canobios-BL is not a skin or eye irritant but should be considered a skin and respiratory sensitiser. Canobios-BL is considered to be efficacious in feedingstuffs for dogs and cats at the use level 5 × 109 CFU/kg complete feed.

Assessment of the feed additive consisting of Enterococcus lactisNCIMB 10415 (Cylactin®) for cats and dogs for the renewal of its authorisation (DSM Nutritional Products Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Cylactin® as a zootechnical feed additive for cats and dogs. The active agent of the additive is Enterococcus lactis NCIMB 10415 and the micro-encapsulated formulation, Cylactin® LBC ME5 PET, was assessed. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for cats and dogs. Regarding user safety, the additive was not shown to be skin and eye irritant, but it should be considered a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 22501 for all animal species for the renewal of its authorisation (Chr. Hansen A/S).

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 the additive consisting of Lentilactobacillus buchneri DSM 22501 as a technological feed additive to improve ensiling of fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There 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 irritant to skin and eye, but owing to its proteinaceous nature it should be considered a respiratory sensitiser. No conclusions could be drawn 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.

Safety and efficacy of a feed additive consisting of Weizmannia faecalis DSM 32016 (TechnoSpore50®) for poultry for fattening, poultry reared for laying/breeding, ornamental birds and suckling and weaned Suidae piglets (Biochem Zusatzstoffe Handels- und Produktionsgesellschaft GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Weizmannia faecalis (formerly identified as Bacillus coagulans) DSM 32016 (TechnoSpore50®) as a zootechnical feed additive for poultry reared for breeding/laying/fattening, ornamental birds and suckling and weaned Suidae piglets. The additive is authorised for use in feed for poultry for fattening, ornamental birds and suckling and weaned Suidae piglets. This application sought the extension of use in feed for poultry reared for breeding/laying and the new authorisation in water for drinking for suckling and weaned Suidae piglets, poultry for fattening, reared for breeding/laying and ornamental birds. Moreover, the applicant requested the authorisation of simultaneous use in feed for poultry reared for breeding and laying with coccidiostats. The identity and the lack of toxigenic activity of the active agent was confirmed, and it did not show resistance to relevant antibiotics; therefore, the strain was presumed safe for the target species, consumers and the environment. Since other components did not introduce concerns, TechnoSpore50® was also considered safe for the target species, consumers and the environment. The additive is not a skin/eye irritant but is a respiratory sensitiser. No conclusions could be drawn on the skin sensitisation potential of the additive. TechnoSpore50® was considered to be efficacious in feed for poultry reared for laying/breeding at 1 × 109 CFU/kg and in water for drinking for poultry reared for fattening, poultry reared for laying/breeding, ornamental birds and for suckling and weaned Suidae piglets at 5 × 108 CFU/L. TechnoSpore50® is compatible with halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium and monensin sodium + nicarbazin, but not with narasin or narasin + nicarbazin. No conclusions could be drawn on the compatibility of TechnoSpore50® with decoquinate, lasalocid A sodium, semduramicin sodium, nicarbazin or amprolium hydrochloride.

Assessment of a feed additive consisting of Lentilactobacillus buchneriDSM 19455 for all animal species for the renewal of its authorisation (Biomin GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lentilactobacillus buchneri DSM 19455 as a technological feed additive for use in easy and moderately difficult to ensile fresh material for all animal species. The Panel concluded that L. buchneri DSM 19455 remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, L. buchneri DSM 19455 was considered to be a respiratory sensitiser. The additive with inulin as a carrier tested is not irritant to skin and eyes. 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.

Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 (Provita LE) for calves for rearing for the renewal of its authorisation (Lactosan GmbH & Co.KG).

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 the additive Provita LE for calves for rearing, consisting of Enterococcus lactis DSM 7134 (formerly identified as Enterococcus faecium) and Lacticaseibacillus rhamnosus DSM 7133 (formerly identified as Lactobacillus rhamnosus) as a zootechnical feed additive. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The FEEDAP Panel concluded that the use of the feed additive in animal nutrition remains safe for calves for rearing, consumers and the environment under the authorised conditions of use. The additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. It was not possible to draw conclusions on the skin sensitisation potential of the additive under assessment. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarumLMG P-21295 for all animal species for the renewal of its authorisation (Chr. Hansen A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum LMG P-21295, a technological additive to improve ensiling of fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There 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, consumers and the environment under the authorised conditions of use. The Panel is not in the position to conclude on the skin and eye irritation potential of the additive. No conclusions can be drawn on the potential of the additive to cause skin sensitisation, but it is considered to be a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Enterococcus lactisDSM 7134 (Bonvital®) for chickens reared for laying and minor poultry species other than those used for laying for the renewal of its authorisation (Lactosan GmbH & Co.KG).

Bonvital® is the trade name for a feed additive currently authorised for use in piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). This opinion concerns the renewal of the authorisation of Bonvital® as a zootechnical additive for chickens reared for laying and minor poultry species other than those used for laying. The active agent of Bonvital® was originally identified as Enterococcus faecium. During the current assessment, the strain was reassigned to Enterococcus lactis. The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® was found to be non-irritant to skin and eyes, but a potential respiratory sensitiser. No conclusions could be drawn on the skin sensitisation potential of the additive. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.

Assessment of the application for modification of the terms of the authorisation of the feed additive consisting of Bacillus subtilisDSM 32324, Bacillus subtilisDSM 32325 and Bacillus amyloliquefaciensDSM 25840 (GalliPro® Fit) for all poultry species for fattening and reared for laying/breeding (Chr. Hansen A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit) as a zootechnical feed additive for all poultry species for fattening and reared for laying or for breeding. The additive is already authorised for use in feed and water for drinking for the above-mentioned species. With this application, the company requested the modification of the current authorisations as regards the simultaneous use of the additive with the coccidiostats monensin, salinomycin, narasin, nicarbazin+narasin and lasalocid. The proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of GalliPro® Fit. The additive is safe for the target species, consumers and the environment. The additive is not a dermal/eye irritant but should be considered a respiratory sensitiser. The FEEDAP Panel was not in the position to conclude on the skin sensitisation potential. The Panel concluded that GalliPro® Fit is compatible with the coccidiostats monensin, salinomycin, narasin, nicarbazin+narasin and lasalocid.

Assessment of the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) NCIMB 30083 for all animal species for the renewal of its authorisation (Chr. Hansen 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 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.

Safety and efficacy of the feed additive consisting of protease produced by Bacillus licheniformis DSM 33099 (ProAct 360) for use in poultry species for fattening or reared for laying/breeding (DSM Nutritional Products Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a protease (ProAct 360) produced by a genetically modified strain of Bacillus licheniformis (DSM 33099) as a zootechnical feed additive for poultry species for fattening or reared for laying/breeding. The production strain and its recombinant DNA were not detected in an intermediate concentrated product representative of the final formulation. The final product did not trigger a safety concern with regard to the genetic modification. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ProAct 360 is considered safe for all growing poultry species at the recommended inclusion level of 30,000 NFP/kg complete feed. The use ProAct 360 as a feed additive did not give rise to concerns for the consumers or the environment. The additive is not an eye or a dermal irritant but should be considered a respiratory sensitiser. In the absence of data, no conclusions could be reached on the skin sensitisation potential of the additive. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 30,000 NFP/kg complete feed for all poultry species for fattening or reared for laying/breeding.

Assessment of the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) NCIMB 30084 for all animal species for the renewal of its authorisation (Chr. Hansen 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 assessment of the application for renewal of authorisation Lactiplantibacillus plantarum (previously Lactobacillus) NCIMB 30084 as a technological feed 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 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, 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.