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The present study aimed to investigate the impact of adding two doses of a commercial probiotic on productive performance, ruminal and fecal microbiome in growing lambs. Forty-two Texel or Ile de France crossbred lambs aged 86.9 ± 8.0 days (body weight: 27.4 ± 3.7 kg) were distributed into three groups: basal diet without probiotic supplementation (CG); basal diet + 1 g/animal/day of probiotic (GP1) and basal diet + 5 g/animal/day of probiotic (GP5). The experimental period was 84 days. The weight was evaluated weekly and dry matter intake (DMI) and leftovers were measured daily. At the end of the experiment, lambs were slaughtered. Feces and rumen fluid were collected for microbiome analysis and rumen fragments for histological evaluation. The use of probiotics did not affect weight gain, but GP1 showed a higher silage and DMI intake than CG (p < 0.001). The CG had a greater thickness of keratinized epithelium and stratum corneum (< 0.001) than GP1 and GP5, and greater total papilla width (p = 0.039) than GP1. There was no difference in the general abundance in the rumen and fecal microbiomes. GP5 had a higher proportion of Azoarcus and Dialister taxa in the rumen fluid (p = 0.012 and p = 0.017, respectively) and higher proportion of Treponema and Fibrobacter taxa in the fecal microbiome (p = 0.015 and p = 0.026, respectively), whereas CG had a higher proportion of Anaeroplasma than the other groups (p = 0.032). These results demonstrated the benefits of probiotics for ruminal epithelium protection and microbial diversity. However, there was no effect on performance parameters. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae NCYC R618 as a zootechnical feed additive (functional group: gut flora stabiliser) for chickens for fattening and other poultry species for fattening and reared for laying. The additive has never been authorised. The strain under assessment S. cerevisiae (NCYC R618) qualifies for the qualified presumption of safety (QPS) and, consequently, the FEEDAP Panel concluded that the product is safe for the target species, the consumers and the environment. The FEEDAP Panel could not conclude on the skin and eye irritation or skin sensitisation potential of the additive. The additive should be considered a respiratory sensitiser. Due to the lack of sufficient data, the Panel cannot conclude on the efficacy of the additive under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 a preparation of dried cells of Saccharomyces cerevisiae CNCM I‐4407 (Actisaf® Sc 47) as a zootechnical additive for rabbits for fattening and non‐food producing rabbits. The applicant provided evidence that the additive currently in the market complies with the existing terms of the authorisation. The Panel concluded that the additive remains safe for the target species, consumers and the environment. Regarding the safety for the user, the additive is not a skin or eye irritant. However, it should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. 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 FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha‐amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non‐irritant to the skin and the solid form was shown to be non‐irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae CNCM I‐1079 as a zootechnical feed additive for dogs and all other Canidae. The additive is intended for use in feed for dogs and all other Canidae at a proposed minimum inclusion level of 1 × 109 CFU per kg of 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 no concerns are expected from other components of the product, the additive is considered safe for the target species. Since the additive is intended to be used only in feed for dogs and other non‐food‐producing animals, an assessment of the safety for the consumer and the environment is not needed. The non‐coated form of the additive was shown to be non‐irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both forms, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Panel was not in the position to conclude on the efficacy of Saccharomyces cerevisiae CNCM I‐1079 at the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae NCYC R618 as a zootechnical feed additive (functional group: gut flora stabiliser) for chickens for fattening and other poultry species for fattening and reared for laying. The additive has never been authorised. The strain under assessment S. cerevisiae (NCYC R618) qualifies for the qualified presumption of safety (QPS) and, consequently, the FEEDAP Panel concluded that the product is safe for the target species, the consumers and the environment. The FEEDAP Panel could not conclude on the skin and eye irritation or skin sensitisation potential of the additive. The additive should be considered a respiratory sensitiser. Due to the lack of sufficient data, the Panel cannot conclude on the efficacy of the additive under the proposed conditions of use.

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. [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae CNCM I‐1079 as a zootechnical feed additive for dogs and all other Canidae. The additive is intended for use in feed for dogs and all other Canidae at a proposed minimum inclusion level of 1 × 109 CFU per kg of 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 no concerns are expected from other components of the product, the additive is considered safe for the target species. Since the additive is intended to be used only in feed for dogs and other non‐food‐producing animals, an assessment of the safety for the consumer and the environment is not needed. The non‐coated form of the additive was shown to be non‐irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both forms, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Panel was not in the position to conclude on the efficacy of Saccharomyces cerevisiae CNCM I‐1079 at the proposed conditions of use.

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.

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 a feed additive consisting of viable cells of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 (Biomin® C5) as a zootechnical additive (functional group: gut flora stabiliser) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying/breeding. Biomin® C5 is marketed in two formulations: a coated and a non‐coated formulation with a total minimum microbial count of 1 × 1011 and 4 × 1010 colony forming unit (CFU)/g product, respectively. The Panel considered that the use of Biomin® C5 in feed at the proposed conditions of use raises no risk for the target species, consumers and the environment. Both coated and non‐coated formulations of Biomin® C5 are considered respiratory and skin sensitisers, but not skin irritants. The FEEDAP Panel was not in the position to conclude on the eye irritation potential of any formulation. Due to lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of the additive in the target species at the proposed conditions of use. Biomin® C5 is compatible with nicarbazin, diclazuril, decoquinate and halofuginone. No conclusions can be drawn on the compatibility of Biomin® C5 with monensin sodium, robenidine hydrochloride, maduramicin ammonium and lasalocid A sodium. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of Cylactin® as zootechnical additive. The active agent of the additive is Enterococcus lactis NCIMB 10415, and three additive formulations currently authorised: Cylactin® LBC G35, Cylactin® LBC ME10 and Cylactin® LBC ME20 plus. The additive is currently authorised in the EU for use in poultry (chickens and minor poultry species for fattening, chickens and minor species reared for laying), calves and kids for rearing and for fattening, sows, suckling and weaned piglets and pigs for fattening. The applicant is now seeking the renewal of its authorisation and the extension of use for chickens and minor poultry species reared for breeding, turkeys for fattening and reared for breeding, ornamental birds, lambs for rearing and for fattening, minor or other ruminants' species for rearing and fattening, minor suckling and weaned Suidae species, pigs and minor Suidae species for fattening, rearing or reproduction. In addition, the applicant is seeking authorisation for use in water for drinking for all above‐mentioned target species and categories. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The FEEDAP Panel concludes that the additive is safe for the target animals, consumers and the environment under the authorised/new proposed conditions of use. The Cylactin® LBC ME10 and LBC ME20 plus are not skin and eye irritants, but no conclusion could be drawn on the potential of Cylactin® LBC G35 to be skin and eye irritant. Moreover, no conclusions could be drawn on the additive skin sensitisation potential. The additive is considered a potential respiratory sensitiser. The efficacy for the new target species/categories as well its use in water was extrapolated from the previous efficacy studies. [ABSTRACT FROM AUTHOR]

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 safety and efficacy of a feed additive consisting of viable cells of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 (Biomin® C5) as a zootechnical additive (functional group: gut flora stabiliser) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying/breeding. Biomin® C5 is marketed in two formulations: a coated and a non‐coated formulation with a total minimum microbial count of 1 × 1011 and 4 × 1010 colony forming unit (CFU)/g product, respectively. The Panel considered that the use of Biomin® C5 in feed at the proposed conditions of use raises no risk for the target species, consumers and the environment. Both coated and non‐coated formulations of Biomin® C5 are considered respiratory and skin sensitisers, but not skin irritants. The FEEDAP Panel was not in the position to conclude on the eye irritation potential of any formulation. Due to lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of the additive in the target species at the proposed conditions of use. Biomin® C5 is compatible with nicarbazin, diclazuril, decoquinate and halofuginone. No conclusions can be drawn on the compatibility of Biomin® C5 with monensin sodium, robenidine hydrochloride, maduramicin ammonium and lasalocid A sodium.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of Cylactin® as zootechnical additive. The active agent of the additive is Enterococcus lactis NCIMB 10415, and three additive formulations currently authorised: Cylactin® LBC G35, Cylactin® LBC ME10 and Cylactin® LBC ME20 plus. The additive is currently authorised in the EU for use in poultry (chickens and minor poultry species for fattening, chickens and minor species reared for laying), calves and kids for rearing and for fattening, sows, suckling and weaned piglets and pigs for fattening. The applicant is now seeking the renewal of its authorisation and the extension of use for chickens and minor poultry species reared for breeding, turkeys for fattening and reared for breeding, ornamental birds, lambs for rearing and for fattening, minor or other ruminants' species for rearing and fattening, minor suckling and weaned Suidae species, pigs and minor Suidae species for fattening, rearing or reproduction. In addition, the applicant is seeking authorisation for use in water for drinking for all above‐mentioned target species and categories. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The FEEDAP Panel concludes that the additive is safe for the target animals, consumers and the environment under the authorised/new proposed conditions of use. The Cylactin® LBC ME10 and LBC ME20 plus are not skin and eye irritants, but no conclusion could be drawn on the potential of Cylactin® LBC G35 to be skin and eye irritant. Moreover, no conclusions could be drawn on the additive skin sensitisation potential. The additive is considered a potential respiratory sensitiser. The efficacy for the new target species/categories as well its use in water was extrapolated from the previous efficacy studies.

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. [ABSTRACT FROM AUTHOR]

Ronozyme® Multigrain G/L is the trade name of the feed additive under assessment containing endo‐1,4‐beta‐xylanase, endo‐1,4‐beta‐glucanase and endo‐1,3(4)‐beta‐glucanase produced by a non‐genetically modified strain of Trichoderma reesei (ATCC 74444). It is authorised for use as a zootechnical additive (functional group: digestibility enhancer) in poultry for fattening, poultry for laying and weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider previous conclusions that the additive is safe for the animal species/categories, the consumer and the environment under the authorised conditions of use. Regarding the safety for the user, the additive should be considered a potential respiratory sensitiser. In absence of data, the Panel could not conclude on the potential of the additive to cause skin and eye irritation or dermal sensitisation. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for poultry for fattening, poultry for laying and weaned piglets. [ABSTRACT FROM AUTHOR]

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®) 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 × 109 CFU/g additive. It is intended to be used as a zootechnical additive in feed for chickens for fattening, turkeys for fattening and laying hens at the recommended application level of 5 × 108 CFU/kg complete feed. In the context of previous opinions, no conclusions could be drawn on the efficacy of the additive in any of the target species based on the data provided. As regards chickens for fattening, in the former opinions the supplementation of the additive at the recommended level showed a significantly greater weight or weight gain compared to birds in the control group only in two studies. New statistical analysis data of one efficacy trial were submitted. The results showed that Biacton® supplemented at 8.5 × 108 CFU/kg feed or at higher levels significantly improved the feed to gain ratio of chickens for fattening compared to control birds or to birds receiving the additive at the recommended level. Therefore, the Panel concluded that Biacton® has the potential to be efficacious in chickens for fattening at the concentration of 8.5 × 108 CFU/kg complete feed. This conclusion was extrapolated to turkeys for fattening. [ABSTRACT FROM AUTHOR]

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 a feed additive consisting of two bacilli strains (tradename: BioPlus® 2B) when used in suckling piglets, calves for fattening and other growing ruminants. BioPlus® 2B is composed of viable cells of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749. In the course of the current assessment, the latest strain was reclassified as Bacillus paralicheniformis. BioPlus® 2B is intended for use in feedingstuffs and water for drinking for the target species at the minimum inclusion level of 1.3 × 109 CFU/kg feed and 6.4 × 108 CFU/l water, respectively. B. paralicheniformis and B. subtilis are considered eligible for the qualified presumption of safety (QPS) approach. The identity of the active agents was established, and the qualifications regarding the lack of acquired antimicrobial resistance genes, toxigenic potential and bacitracin production ability were complied with. Following the QPS approach, B. paralicheniformis DSM 5749 and B. subtilis DSM 5750 are presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, BioPlus® 2B was also considered safe for the target species, consumers and the environment. BioPlus® 2B is not irritant to the eyes or skin but should be considered a respiratory sensitiser. The Panel could not conclude on the skin sensitisation potential of the additive. BioPlus® 2B when supplemented at 1.3 × 109 CFU/kg complete feed and 6.4 × 108 CFU/l water for drinking has the potential to be efficacious in suckling piglets, calves for fattening and other growing ruminants (e.g. sheep, goat, buffalo) at the same developmental stage. [ABSTRACT FROM AUTHOR]

Abstract 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.

Abstract Ronozyme® Multigrain G/L is the trade name of the feed additive under assessment containing endo‐1,4‐beta‐xylanase, endo‐1,4‐beta‐glucanase and endo‐1,3(4)‐beta‐glucanase produced by a non‐genetically modified strain of Trichoderma reesei (ATCC 74444). It is authorised for use as a zootechnical additive (functional group: digestibility enhancer) in poultry for fattening, poultry for laying and weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider previous conclusions that the additive is safe for the animal species/categories, the consumer and the environment under the authorised conditions of use. Regarding the safety for the user, the additive should be considered a potential respiratory sensitiser. In absence of data, the Panel could not conclude on the potential of the additive to cause skin and eye irritation or dermal sensitisation. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for poultry for fattening, poultry for laying and weaned piglets.

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 efficacy of the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I‐3740 (tradename: Biacton®) 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 × 109 CFU/g additive. It is intended to be used as a zootechnical additive in feed for chickens for fattening, turkeys for fattening and laying hens at the recommended application level of 5 × 108 CFU/kg complete feed. In the context of previous opinions, no conclusions could be drawn on the efficacy of the additive in any of the target species based on the data provided. As regards chickens for fattening, in the former opinions the supplementation of the additive at the recommended level showed a significantly greater weight or weight gain compared to birds in the control group only in two studies. New statistical analysis data of one efficacy trial were submitted. The results showed that Biacton® supplemented at 8.5 × 108 CFU/kg feed or at higher levels significantly improved the feed to gain ratio of chickens for fattening compared to control birds or to birds receiving the additive at the recommended level. Therefore, the Panel concluded that Biacton® has the potential to be efficacious in chickens for fattening at the concentration of 8.5 × 108 CFU/kg complete feed. This conclusion was extrapolated to turkeys 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 a feed additive consisting of two bacilli strains (tradename: BioPlus® 2B) when used in suckling piglets, calves for fattening and other growing ruminants. BioPlus® 2B is composed of viable cells of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749. In the course of the current assessment, the latest strain was reclassified as Bacillus paralicheniformis. BioPlus® 2B is intended for use in feedingstuffs and water for drinking for the target species at the minimum inclusion level of 1.3 × 109 CFU/kg feed and 6.4 × 108 CFU/l water, respectively. B. paralicheniformis and B. subtilis are considered eligible for the qualified presumption of safety (QPS) approach. The identity of the active agents was established, and the qualifications regarding the lack of acquired antimicrobial resistance genes, toxigenic potential and bacitracin production ability were complied with. Following the QPS approach, B. paralicheniformis DSM 5749 and B. subtilis DSM 5750 are presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, BioPlus® 2B was also considered safe for the target species, consumers and the environment. BioPlus® 2B is not irritant to the eyes or skin but should be considered a respiratory sensitiser. The Panel could not conclude on the skin sensitisation potential of the additive. BioPlus® 2B when supplemented at 1.3 × 109 CFU/kg complete feed and 6.4 × 108 CFU/l water for drinking has the potential to be efficacious in suckling piglets, calves for fattening and other growing ruminants (e.g. sheep, goat, buffalo) at the same developmental stage.

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 Saccharomyces cerevisiae CNCM I‐1079 when used as a zootechnical additive (gut flora stabilisers and physiological condition stabilisers) for calves, all other ruminant species and for camelids for rearing and for fattening. The product, manufactured in two forms, as a powder and an encapsulated form, is intended for use in complete feed at a minimum inclusion level of 1 × 109 CFU/kg complete feed. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the strain has been clearly established and the additive is composed mainly by dried cells of the active agent, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive is not a skin or eye irritant, or a skin sensitiser, but should be considered a respiratory sensitiser. However, exposure by inhalation to the encapsulated form is unlikely. The Panel was not in the position to conclude on the efficacy of the additive for the target species. [ABSTRACT FROM AUTHOR]

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 Saccharomyces cerevisiae CNCM I‐1079 when used as a zootechnical additive (gut flora stabilisers and physiological condition stabilisers) for calves, all other ruminant species and for camelids for rearing and for fattening. The product, manufactured in two forms, as a powder and an encapsulated form, is intended for use in complete feed at a minimum inclusion level of 1 × 109 CFU/kg complete feed. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the strain has been clearly established and the additive is composed mainly by dried cells of the active agent, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive is not a skin or eye irritant, or a skin sensitiser, but should be considered a respiratory sensitiser. However, exposure by inhalation to the encapsulated form is unlikely. The Panel was not in the position to conclude on the efficacy of the additive for the target species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of Lactobacillus acidophilus CECT 4529 (tradename: Lactobacillus acidophilus D2/CSL) when used as a zootechnical additive for all poultry species and categories and all ornamental birds. The additive is authorised for use in laying hens, chickens for fattening, cats and dogs. With this application, the company requested a new authorisation for use in feed and water for drinking for all poultry species and categories and ornamental birds. The Panel concluded that Lactobacillus acidophilus D2/CSL is presumed safe for the target species, consumers and the environment. As in previous opinions, the Panel also concluded that it is considered an eye/skin irritant and a skin/respiratory sensitiser. Lactobacillus acidophilus D2/CSL when supplemented at 1 × 109 CFU/kg complete feed or 5 × 108 CFU/L water for drinking has the potential to be efficacious in to improving either laying or growing performance in all poultry species/categories and ornamental birds. [ABSTRACT FROM AUTHOR]

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 Lactobacillus acidophilus CECT 4529 (tradename: Lactobacillus acidophilus D2/CSL) when used as a zootechnical additive for all poultry species and categories and all ornamental birds. The additive is authorised for use in laying hens, chickens for fattening, cats and dogs. With this application, the company requested a new authorisation for use in feed and water for drinking for all poultry species and categories and ornamental birds. The Panel concluded that Lactobacillus acidophilus D2/CSL is presumed safe for the target species, consumers and the environment. As in previous opinions, the Panel also concluded that it is considered an eye/skin irritant and a skin/respiratory sensitiser. Lactobacillus acidophilus D2/CSL when supplemented at 1 × 109 CFU/kg complete feed or 5 × 108 CFU/L water for drinking has the potential to be efficacious in to improving either laying or growing performance in all poultry species/categories and ornamental birds.

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 BA‐KING®Bacillus velezensis when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non‐food producing species. The product under assessment is based on viable spores of a strain identified as B. velezensis, which is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NITE BP‐01844 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, BA‐KING® is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. BA‐KING® is not irritant to skin but is potentially irritant to eyes. In addition, should be considered a skin and respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of BA‐KING® for the target species. [ABSTRACT FROM AUTHOR]

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 Calsporin® (Bacillus velezensis DSM 15544) as a zootechnical additive for dairy cows and other dairy ruminants. The product under assessment is based on viable spores of Bacillus velezensis DSM 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 compliance with the applicable qualifications confirmed. Therefore, B. velezensis DSM 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 FEEDAP Panel is not in the position to conclude on the efficacy of Calsporin® for dairy cows or other dairy ruminants based on the data provided. [ABSTRACT FROM AUTHOR]

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 BA‐KING® Bacillus velezensis when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non‐food producing species. The product under assessment is based on viable spores of a strain identified as B. velezensis, which is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NITE BP‐01844 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, BA‐KING® is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. BA‐KING® is not irritant to skin but is potentially irritant to eyes. In addition, should be considered a skin and respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of BA‐KING® 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 assessment of Calsporin® (Bacillus velezensis DSM 15544) as a zootechnical additive for dairy cows and other dairy ruminants. The product under assessment is based on viable spores of Bacillus velezensis DSM 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 compliance with the applicable qualifications confirmed. Therefore, B. velezensis DSM 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 FEEDAP Panel is not in the position to conclude on the efficacy of Calsporin® for dairy cows or other dairy ruminants based on the data provided.

The aim of this study was to evaluate the effect of dietary supplementation with Agave fourcroydes powder on growth performance, carcass traits, organ weights, gut morphometry, and blood biochemistry in broiler rabbits. A total of 40 male rabbits (New Zealand × Californian) weaned at 35 d were randomly selected for a control diet (CD) and CD + 1.5% of A. fourcroydes powder, with 10 replicates and two rabbits per replicate. After 60 d, A. fourcroydes powder increased body weight, feed intake, and weight gain (P0.05). Furthermore, this natural product did not affect the edible portions and the indicators determined in the Longissimus dorsi, nor the organ relative weights and the intestinal morphometry (P>0.05); however, a decrease in cecal pH was observed and consequently an increase in cecal beneficial bacteria (P0.05). Agave fourcroydes powder as a zootechnical additive promoted better growth, in addition, it showed lipid-lowering and hypoglycemic effects, without modifying the edible portions and organs digestive.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bovaer® 10 as a zootechnical additive for ruminants for milk production and reproduction. Systemic exposure or site of contact toxicity for the active substance 3-nitrooxypropanol (3-NOP), for which genotoxicity has not been fully clarified, in the target species, is unlikely based on ADME data available. Consequently, the FEEDAP Panel concluded that Bovaer® 10 was safe for dairy cows at the maximum recommended level. However, as a margin of safety could not be established, the FEEDAP Panel could not conclude on the safety of the additive for other animal species/categories. The FEEDAP Panel considered that the consumer was exposed to 3-nitrooxypropionic acid (NOPA), which is one of the 3-NOP metabolites. NOPA was not genotoxic based on the studies provided. The FEEDAP Panel concluded that the use of Bovaer® 10 in animal nutrition under the conditions of use proposed was of no concern for consumer safety and for the environment. The FEEDAP Panel concluded that the active substance 3-NOP may be harmful if inhaled. It is irritant (but not corrosive) to skin, irritant to the eyes but it is not a skin sensitiser. As the genotoxicity of 3-NOP is not completely elucidated, the exposure through inhalation of the additive may represent an additional risk for the user. The Panel concluded that the additive has a potential to be efficacious in dairy cows to reduce enteric methane production under the proposed conditions of use. This conclusion was extrapolated to all other ruminants for milk production and reproduction. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bacillus velezensis DSM 15544 (Calsporin®) when used as a feed additive for piglets (suckling and weaned), pigs for fattening, sows in order to have benefit in piglets, ornamental fish, dogs and all avian species. The additive is authorised for use in sows, suckling and weaned piglets, pigs for fattening, chickens for fattening, laying hens, ornamental fish and dogs. With this application the company requested a new authorisation for all avian species and the modification of the current authorisations as regards the strain taxonomy from Bacillus subtilis DSM 15544 to B. velezensis DSM 15544. The FEEDAP Panel concluded that the active agent of Calsporin® should be taxonomically designated as Bacillus velezensis DSM 15544. The Panel also concluded that Calsporin® is presumed safe for the target species, consumers and the environment. Calsporin® is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. Calsporin® when supplemented at 3 × 108 CFU/kg complete feed has the potential to be efficacious in all avian species for rearing, fattening, laying and breeding purposes. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bacillus velezensis DSM 15544 (Calsporin®) when used as a feed additive for piglets (suckling and weaned), pigs for fattening, sows in order to have benefit in piglets, ornamental fish, dogs and all avian species. The additive is authorised for use in sows, suckling and weaned piglets, pigs for fattening, chickens for fattening, laying hens, ornamental fish and dogs. With this application the company requested a new authorisation for all avian species and the modification of the current authorisations as regards the strain taxonomy from Bacillus subtilis DSM 15544 to B. velezensis DSM 15544. The FEEDAP Panel concluded that the active agent of Calsporin® should be taxonomically designated as Bacillus velezensis DSM 15544. The Panel also concluded that Calsporin® is presumed safe for the target species, consumers and the environment. Calsporin® is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. Calsporin® when supplemented at 3 × 108 CFU/kg complete feed has the potential to be efficacious in all avian species for rearing, fattening, laying and breeding purposes.

Abstract The additive Biosprint® contains viable cells of Saccharomyces cerevisiae MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to all pigs (other than sows and weaned piglets) and other minor porcine species at a minimum inclusion level of 3 × 109 CFU/kg feed. S. cerevisiae is considered by EFSA to have qualified presumption of safety (QPS) status and consequently is considered safe for the target species, the consumers and the environment. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. In previous evaluations, the FEEDAP Panel concluded that the additive is efficacious in sows and weaned piglets. In the current application, these conclusions are extrapolated to all pigs (other than sows and weaned piglets) and to other minor porcine species.

Abstract The additive Biosprint® contains viable cells of Saccharomyces cerevisiae MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to cats and dogs at a minimum inclusion level of 7 × 1010 CFU/kg of complete feed. S. cerevisiae is considered by EFSA to have qualified presumption of safety status and consequently is considered safe for the target species. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. Based on the results on efficacy studies provided, the FEEDAP Panel concludes that Biosprint® is efficacious when used in feeds for dogs. However, the FEEDAP Panel considered that the biological relevance of the magnitude of the effect detected is questionable. Based on the trial available, the FEEDAP Panel was unable to conclude on the efficacy of the additive when administered to cats.

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).

The aim of this study was to evaluate the effect of dietary supplementation with Jgave fourcroydes powder on growth performance, carcass traits, organ weights, gut morphometry, and blood biochemistry in broiler rabbits. A total of 40 male rabbits (New Zealand x Californian) weaned at 35 d were randomly selected for a control diet (CD) and CD + 1.5% of A. fourcroydes powder, with 10 replicates and two rabbits per replicate. After 60 d, A. fourcroydes powder increased body weight, feed intake, and weight gain (P<0.05), without affecting feed conversion ratio and viability (P>0.05). Furthermore, this natural product did not affect the edible portions and the indicators determined in the Longissimus dorsi, nor the organ relative weights and the intestinal morphometry (P>0.05); however, a decrease in cecal pH was observed and consequently an increase in cecal beneficial bacteria (P<0.05) were found. Also, A. fourcroydes powder reduced (P<0.05) the serum concentration of glucose, harmful lipids, HDL and atherogenic index although without change for the ureic nitrogen, creatinine and VLDL (P>0.05). Agave fourcroydes powder as a zootechnical additive promoted better growth, in addition, it showed lipid-lowering and hypoglycemic effects, without modifying the edible portions and organs digestive. [ABSTRACT FROM AUTHOR]

The additive Biosprint® contains viable cells of Saccharomyces cerevisiae MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to cats and dogs at a minimum inclusion level of 7 9 1010 CFU/kg of complete feed. S. cerevisiae is considered by EFSA to have qualified presumption of safety status and consequently is considered safe for the target species. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. Based on the results on efficacy studies provided, the FEEDAP Panel concludes that Biosprint® is efficacious when used in feeds for dogs. However, the FEEDAP Panel considered that the biological relevance of the magnitude of the effect detected is questionable. Based on the trial available, the FEEDAP Panel was unable to conclude on the efficacy of the additive when administered to cats. [ABSTRACT FROM AUTHOR]

The additive Biosprint® contains viable cells of Saccharomyces cerevisiae MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to all pigs (other than sows and weaned piglets) and other minor porcine species at a minimum inclusion level of 3 9 109 CFU/kg feed. S. cerevisiae is considered by EFSA to have qualified presumption of safety (QPS) status and consequently is considered safe for the target species, the consumers and the environment. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. In previous evaluations, the FEEDAP Panel concluded that the additive is efficacious in sows and weaned piglets. In the current application, these conclusions are extrapolated to all pigs (other than sows and weaned piglets) and to other minor porcine species. [ABSTRACT FROM AUTHOR]

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 × 109CFU/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 FROM AUTHOR]

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 efficacy of the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I‐3740 (tradename: Biacton®) 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 × 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® 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® 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® in chickens for fattening, turkeys for fattening and laying hens.

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 feed additive consisting of dimethylglycine sodium salt (trade name: Taminizer D) as a zootechnical additive for chickens for fattening. In 2011, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive, and subsequently, the additive was authorised in the EU. In 2018, a second scientific assessment was made based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is authorised as ‘dimethylglycine sodium salt with a purity of at least 97%’ for chickens for fattening under the category ‘zootechnical additives’ and functional group ‘other zootechnical additives (improvement of zootechnical parameters)’. The evidence provided by the applicant indicated that the additive currently in the market, produced by the two manufacturing routes, complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. The FEEDAP Panel concludes that Taminizer D is not a skin irritant but may be an eye irritant and a skin sensitiser; although uncertainty remains on the presence of formaldehyde, exposure is considered extremely low. There is no need to assess 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 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 Danisco Xylanase 40000 G/L is the trade name of the feed additive under assessment and contains endo‐1,4‐beta‐xylanase produced by a genetically modified strain of Trichoderma reesei. It is authorised for use in chickens for fattening, laying hens, ducks, turkeys for fattening, all minor poultry species, weaned piglets and pigs for fattening. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation, a reduction of the minimum recommended level in turkeys for fattening and the extension of use to all poultry species (other than ducks) for fattening or reared for laying/breeding and for laying, suckling piglets and minor growing porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the EFSA Panel on Additives and products or Substances used in Animal Feed (FEEDAP) to reconsider previous conclusions that the additive remains safe for the animal species/categories, the consumer and the environment under the authorised conditions of use. This conclusion applies also to the new target species/categories for which a request of use is made. The additive is not irritant to skin but should be considered as a possible eye irritant and, in common with other proteinaceous substances, respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for chickens for fattening, laying hens, ducks, all minor poultry species, weaned piglets and pigs for fattening. The additive has the potential to be efficacious at 625 U/kg complete feed in all poultry species for fattening (including turkeys) or reared for laying/breeding, and for laying and 2,000 U/kg complete feed in suckling piglets and all minor growing porcine 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 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 The feed additive under assessment (trade name: Miya‐Gold® S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya‐Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya‐Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya‐Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya‐Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.

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.