Safety and efficacy of the feed additive consisting of ammonium chloride (Ammonium Chloride AF) for all ruminants, dogs and cats for the renewal of its authorisation (BASF SE).

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 ammonium chloride (tradename: Ammonium chloride AF) as a zootechnical additive for ruminants, cats and dogs. In 2012, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive and subsequently the additive was authorised in the EU. The additive is authorised as 'ammonium chloride with a content of ammonium chloride ≥ 99% and sodium chloride ≤ 0.5% in the active substance' for ruminants, cats and dogs under the category 'zootechnical additives' and functional group 'other zootechnical additives'. The evidence provided by the applicant indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsider its previous conclusions on the safety for target species, consumers and environment. The FEEDAP Panel concludes that ammonium chloride is considered an eye and skin irritant and a potential respiratory sensitiser, but is not a dermal sensitiser. The present application for renewal of the authorisation does 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.

Safety and efficacy of a feed additive consisting of agar for pets and non-food-producing animals (Hispanagar).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of agar as a feed additive for pets and non-food-producing animals. Owing the lack of information, the FEEDAP Panel is not in the position to conclude on the safety of agar for pets and other non-food-producing animals and for the user. The FEEDAP Panel concludes that the additive is efficacious as a gelling agent, thickener and contributes to stabilise canned pet feed. No conclusion can be drawn on the efficacy of the additive as a binder.

Safety and efficacy of a feed additive consisting of acacia gum (gum Arabic) for all animal species (A.I.P.G. Association for International Promotion of Gums).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of acacia gum (gum Arabic) as a feed additive for all animal species. Acacia gum is safe up to approximately 280 mg/kg complete feed for chickens for fattening, 375 mg/kg complete feed for turkeys for fattening, 400 mg/kg complete feed for rabbit, 500 and 600 mg/kg complete feed for piglets and pigs for fattening, respectively, 1,100 mg/kg complete feed for cattle for fattening and 1,250 mg/kg complete feed for veal calves and salmonids. No conclusions can be reached on the safety for long living and reproductive animal, until the genotoxic potential of the additive is fully assessed in the framework of its use as a feed additive. No exposure of the consumer to the additive or its metabolites is expected. Therefore, the use of the additive in animal nutrition is considered safe for the consumers. Acacia gum is a potential dermal and respiratory sensitiser. No conclusion can be reached on the irritating potential to the skin or eyes. The use of acacia gum in animal nutrition is considered safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of acacia gum.

Safety and efficacy of a feed additive consisting of guar gum for all animal species (A.I.P.G. Association for International Promotion of Gums).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of guar gum as a feed additive for all animal species. Owing the absence of information, the genotoxic potential of the additive could not be fully assessed. From the results of tolerance studies, the FEEDAP Panel concluded that guar gum is safe for salmonids at a maximum concentration of 3,000 mg/kg complete feed. Guar gum is safe up to ~ 280 mg/kg complete feed for chickens for fattening, 375 mg/kg complete feed for turkeys for fattening, 400 mg/kg complete feed for rabbits, 500 and 600 mg/kg complete feed for piglets and pigs for fattening, respectively, 1,100 mg/kg complete feed for cattle for fattening and 1,150 mg/kg complete feed for veal calves. No conclusions can be reached on the safety for long living and reproductive animals, until the genotoxic potential of the additive is fully assessed in the framework of its use as a feed additive. The use of the additive in animal nutrition is considered safe for the consumer and the environment. In the absence of data, no conclusions could be drawn on the safety of the additive for the user. Guar gum is efficacious as a gelling agent, thickener, and contributes to stabilise canned pet feed. No conclusion can be drawn on the additive as an emulsifier.

Safety and efficacy of a feed additive consisting of carrageenan for pets and other non-food-producing animals (Marinalg International).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of carrageenan as a feed additive for pets and other non-food-producing animals. The additive is manufactured in two forms, refined and semi-refined carrageenan. Owing the lack of information, the FEEDAP Panel is not in the position to conclude on safety of the additives for pets and other non-food-producing animals and for the user. The FEEDAP Panel concludes that the additive is efficacious as a gelling agent, thickener and contributes to stabilise canned pet feed. No conclusion can be drawn on the efficacy of the additive as a binder and emulsifier.

Assessment of the feed additive consisting of Lactococcus lactis DSM 11037 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 Lactococcus lactis DSM 11037, a technological additive to improve ensiling of forage for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not a skin and eye irritant but should be considered a respiratory sensitiser. In absence of data, the Panel cannot conclude on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactococcus lactis NCIMB 30117 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 Lactococcus lactis NCIMB 30117 as a technological additive for use in forage for all animal species. The additive aims to improve the production of silage and is authorised for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation, and eye and skin irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of sodium alginate for all animal species (ALGAIA).

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 sodium alginate for all animal species. The additive is intended to be used as a technological additive (functional groups: thickeners and gelling agents). Sodium alginate is intended to be used in feedingstuffs for all animal species at a proposed minimum concentration of 2,000 mg/kg feed and a maximum concentration of to 30,000 mg/kg feed. The data provided for the composition of the additive does not allow a proper assessment of the product consistency, purity and physico-chemical properties. Sodium alginate is not irritant to skin but should be considered irritant to eyes, a skin and respiratory sensitiser and hazardous by inhalation. Sodium alginate is a high-molecular-weight polymer naturally occurring in brown algae. The use of sodium alginate in animal nutrition is considered safe for the consumers and the environment. No conclusion could be drawn on the safety of sodium alginate for the target species or on its efficacy as a thickener or gelling agent in feed.

Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH).

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 zearalenone hydrolase (ZenA) produced by Escherichia coli DSM 32731 when used as a feed additive for all terrestrial animals. The production strain E. coli DSM 32731 is genetically modified and harbours a kanamycin resistance gene. No viable cells of the production strain were detected in the final product, but uncertainty remains on the presence of recombinant DNA in the final product. The ZenA contained in the additive is safe for all terrestrial animal species up to the maximum use levels of (in U/kg complete feed): 100 U/kg in chickens for fattening; 150 U/kg in laying hens, turkeys for fattening and rabbits; 200 U/kg in pigs; 250 U/kg in dairy cows; 400 U/kg in veal calf (milk replacer), cattle for fattening, sheep, goats, horses and cats; and 450 U/kg in dogs. Based on the ADME and toxicological data, the FEEDAP Panel considers that the use of the ZenA contained in the additive in animal nutrition is safe for the consumers. The endotoxin content in the additive poses a risk by inhalation for users handling the additive. The additive is not a skin/eye irritant nor a skin sensitiser. Due to its proteinaceous nature, the additive should be considered as a potential respiratory sensitiser. The ZenA contained in the additive and the resulting breakdown products of its enzymatic activity do not represent a safety concern for the environment. The production strain harbours an antimicrobial resistance gene and uncertainties remain on the possible presence of its recombinant DNA in the final product; therefore, the FEEDAP Panel cannot conclude on safety of the additive for the target species, the consumer, the user and the environment.

Assessment of the feed additive consisting of Lactococcus lactis NCIMB 30160 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

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 Lactococcus lactis NCIMB 30160 as a technological additive for all animal species. The additive aims to improve the production of silage and is authorised for all animal species. The applicant provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, Lactococcus lactis NCIMB 30160 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of the feed additive consisting of selenium-enriched yeast (Saccharomyces cerevisiae CNCM I-3060) for all animal species (Alltech Ireland).

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 selenium-enriched yeast (Saccharomyces cerevisiae CNCM I-3060) for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised as selenomethionine produced by S. cerevisiae CNCM I-3060 as a nutritional additive (compound of trace elements) with a minimum selenium content of 2,000 mg/kg. The applicant proposed the inclusion of an additional formulation with a minimum content of selenium in the additive of 3,000 mg/kg. Considering (i) that the main changes in the manufacturing of the product compared to the former application involve the drying phase (spray-drying vs drum drying), which has led to slightly different values of the dusting potential and particle size, and (ii) the conditions of use already authorised, the FEEDAP Panel stated that the modification requested would only affect the safety for the target animals and the users, without impacting the safety for the consumers, safety for the environment or the efficacy of the additive. The FEEDAP Panel concluded that there are no concerns for the safety of the target animals based on its previous assessment and an additional study on homogeneity of the additive. The additive is hazardous by inhalation, is not irritant for the eyes, skin and is not a dermal sensitiser.

Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal 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 iron (II) chelate of amino acids hydrate for all animal species, brand name Availa® Fe, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 9% iron. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to include a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (iron), with an inclusion level of 9-10%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/2330. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust, it is not possible to make the assessment of the exposure by inhalation.

Assessment of the feed additive consisting of Levilactobacillus brevis (formerly Lactobacillus brevis) DSM 12835 EU for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Levilactobacillus brevis (formerly Lactobacillus brevis) DSM 12835 as a technological additive for all animal species. The additive aims to improve the production of silage and is authorised without a minimum inclusion level. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, L. brevis DSM 12835 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

Assessment of the feed additive consisting of Lacticaseibacillus paracasei (formerly Lactobacillus paracasei)DSM 16245 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

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

Safety and efficacy of a feed additive consisting of manganese chelate of amino acids hydrate for all animal species (Zinpro Animal Nutrition (Europe) Inc.).

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 manganese chelate of amino acids hydrate, brand name Availa®Mn, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 8% manganese. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 17%; and (iii) to introduce a tighter specification on the mineral content (manganese), with an inclusion level of 8-9%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/1490. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation.

Safety and efficacy of a feed additive consisting of zinc chelate of amino acids hydrate for all animal species (Zinpro Animal Nutrition (Europe) Inc.).

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 zinc chelate of amino acids hydrate, brand name Availa® Zn, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein with a minimum content of 10% zinc. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 17%; (iii) to introduce a tighter specification of the zinc content of 10-11%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2016/1095. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation.

Safety and efficacy of a feed additive consisting of copper (II) chelate of amino acids hydrate for all animal species (Zinpro Animal Nutrition (Europe) Inc.).

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 copper (II) chelate of amino acids hydrate, brand name Availa®Cu, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 10% copper. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (copper), with an inclusion level of 10-11%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2018/1039. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation.

Safety and efficacy of a feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 26571 for all animal species (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 safety and efficacy of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 26571 when used as a technological additive intended to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. The additive is not irritant to skin or eyes and is not a skin sensitiser but should be considered a potential respiratory sensitiser. The FEEDAP Panel concluded that the addition of Lactiplantibacillus plantarum DSM 26571 at a minimum concentration of 1 × 108 CFU/kg may improve the production of silage from easy, moderately difficult and difficult to ensile forage material.

Safety and efficacy of an additive consisting of xanthan gum produced by Xanthomonas campestris strains ■■■■■, ■■■■■for all animal species (Biopolymer International).

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 xanthan gum as a feed additive for all animal species. Xanthan gum is manufactured using different production strains belonging to the X. campestris species. The identity of the strains producing xanthan gum was not unambiguously established, data on antimicrobial susceptibility were incomplete, and it was not possible to exclude the presence in the additive of viable cells/DNA of the production strains. Consequently, no conclusions could be drawn on the safety of the X. campestris strains ■■■■■. Considering the above and in the absence of adequate information on the additive under assessment, the FEEDAP Panel cannot conclude on the safety of xanthan gum produced by the X. campestris strains ■■■■■ for the target species, the consumer, the user and the environment. Xanthan gum is considered as an efficacious stabiliser and thickener in feedingstuffs for all animal species at the proposed conditions of use.