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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l‐arginine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.401). The additive is intended to be used in feed and water for drinking for all animal species and categories. The genetic modifications introduced do not raise safety concerns. No viable cells or DNA of the production strain were detected in the final product. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not pose any safety concern with regard to the production strain. l‐Arginine produced with E. coli CGMCC 7.401 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed and water. The use of l‐arginine produced with E. coli CGMCC 7.401 in animal nutrition is considered safe for the consumers and for the environment. The endotoxin activity of the additive does not represent a hazard for persons handling the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The additive l‐arginine produced with E. coli CGMCC 7.401 is regarded as an efficacious source of the essential amino acid l‐arginine for non‐ruminant species. For supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐valine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 22721) as a nutritional additive for all animal species. The production strain and its DNA were not detected in the final additive. Therefore, the final product does not give raise to any safety concern regarding the genetic modification of the production strain. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that l‐valine produced using E. coli CGMCC 22721 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of l‐valine produced using E. coli CGMCC 22721 in animal nutrition is considered safe for the consumers and for the environment. The FEEDAP Panel cannot conclude on the potential of l‐valine produced using E. coli CGMCC 22721 to irritant to the skin or eyes, a dermal or respiratory sensitiser due to the lack of data. The endotoxin activity of the additive does not represent a hazard for users handling the additive when exposed by inhalation. The additive l‐valine produced by fermentation using E. coli CGMCC 22721 is regarded as an efficacious source of the essential amino acid l‐valine for non‐ruminant nutrition. For the supplemental l‐valine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a Camellia oleifera C.Abel seed extract (Cosap®) as technological feed additive for all animal species except fin fish. In the absence of adequate tolerance studies in the target species or toxicological studies with the additive under assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of C. oleifera extract for the target species. The use of the additive in animal nutrition is not expected to cause concern for consumer safety. The additive is considered as irritant to the eyes and mucous membranes. No conclusions can be reached on the potential of the additive to be irritant to the skin or to be a dermal sensitiser. The use of the additive under the proposed conditions of use is considered safe for the terrestrial compartment. However, no conclusion can be reached on the safety of the additive for the environment when used in feed of aquatic animals other than fin fish. The Panel concluded that the additive has the potential to be efficacious as an emulsifier when used according to proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Loigolactobacillus coryniformis DSM 34345 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with all fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. coryniformis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Loigolactobacillus coryniformis DSM 34345 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Loigolactobacillus coryniformis DSM 34345 has the potential to improve the production of silages prepared from all fresh plant materials at a minimum concentration of 1 × 108 CFU/kg fresh material.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) for the renewal of its authorisation as zootechnical feed additive for pigs for fattening, minor porcine species for fattening and turkeys for fattening. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive Avemix® XG 10 with calcium carbonate + wheat flour and Avemix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) noted that no data were submitted to support compliance of the formulation of Avemix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both forms of the additive remain safe for pigs for fattening, minor porcine species for fattening and turkeys for fattening, consumers and the environment. Regarding the safety for the user, Avemix® XG 10 formulated with calcium carbonate + sepiolite and Avemix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of Avemix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in all its formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use in weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive AveMix® XG 10 with calcium carbonate + wheat flour and AveMix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal FEED (FEEDAP) noted that no data were submitted to support compliance of the formulation of AveMix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both formulations of the additive (powder and liquid) remain safe for the target species, consumers and the environment, and that the extension of use to suckling piglets would not affect these conclusions. AveMix® XG 10 formulated with calcium carbonate + sepiolite and AveMix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in all its formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 4000 XU and 900 BGU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) for the renewal of its authorisation as a zootechnical feed additive for laying hens and minor poultry species for fattening and laying. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive AveMix® XG 10 with calcium carbonate + wheat flour and AveMix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) noted that no data were submitted to support compliance of the formulation of AveMix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both formulations of the additive (powder and liquid) remain safe for laying hens and minor poultry species for fattening and laying, consumers and the environment. AveMix® XG 10 formulated with calcium carbonate + sepiolite and AveMix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in both formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactococcus lactis DSM 34262 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in easy and moderately difficult to ensile fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. lactis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Lactococcus lactis DSM 34262 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Lactococcus lactis DSM 34262 has the potential to improve the fermentation of the silage prepared from fresh plant material with a DM range of 30–35% at a minimum concentration of 1 × 108 CFU/kg fresh material.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of 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 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755), endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) and polygalacturonase (produced with Aspergillus fijiensis CBS 589.94) (AveMix® 02 CS/ AveMix® 02 CS L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use with weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There was no new evidence that would lead the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions that the additive is safe for weaned piglets, the consumer and the environment under the authorised conditions of use. This conclusion applied also to the new target species (suckling piglets) for which a request for an extension of use was made. The additive in both formulations (powder and liquid) is not irritant to skin or eyes but should be considered a dermal and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 2140 XU, 1230 BGU and 46 PGLU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of l‐tyrosine as a nutritional feed additive. The additive is authorised for use in all animal species (3c401). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed concluded that the use of the feed additive in animal nutrition remains safe for the target species, consumers, and the environment. As regards the safety for the user, l‐tyrosine is not an irritant to skin or eyes. In the absence of data, the potential of l‐tyrosine to be a dermal and respiratory sensitiser cannot be excluded. Exposure by inhalation of persons handling the additive is likely. The present application for renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and, therefore, there is no need for re‐assessing the efficacy.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactiplantibacillus plantarum DSM 34271 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in easy and moderately difficult to ensile fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Lactiplantibacillus plantarum DSM 34271 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Lactiplantibacillus plantarum DSM 34271 has the potential to improve the fermentation of the silage prepared from fresh plant material with a DM range of 30%–35% at a minimum concentration of 1 × 108 CFU/kg fresh material.

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 liquid l‐lysine base produced with a genetically modified strain of Corynebacterium glutamicum as a nutritional feed additive for all animal species. The l‐lysine base liquid produced with C. glutamicum NRRL B‐67535 and NRRL B‐67439 is currently authorised as a nutritional additive for all animal species. The present application is aimed at modifying the current authorisation to include C. glutamicum NRRL B‐68248 as a production strain. The new production strain qualifies for the qualified presumption of safety approach when used for production purposes. It was unambiguously identified as C. glutamicum and was shown not to harbour acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. All the introduced sequences or mutations were considered to be safe, and no viable cells or DNA of the NRRL B‐68248 strain was detected in the final product. Therefore, the final product does not pose any safety concern associated with the production strain. l‐Lysine base produced using C. glutamicum NRRL B‐68248 does not represent a risk for the target species, the consumer or the environment. The additive was considered to be neither irritant to skin or the eyes, nor a dermal sensitiser. l‐Lysine base produced with C. glutamicum NRRL B‐68248 is considered to be an efficacious source of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Quillaja saponaria powder and Yucca schidigera powder (Magni‐Phi®) for all avian species (to slaughter age/weight, or to the point of lay) and ornamental birds, as a zootechnical additive (digestibility enhancer and other zootechnical additives). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening at the level of 250 mg/kg complete feed with a margin of safety of 20 assuming that the additive contains 3.58% of saponins. This conclusion was extrapolated to all growing poultry species and ornamental birds. The Panel concluded that the use of the feed additive in animal nutrition at 250 mg/kg complete feed is of no concern for the safety for the consumer and the environment. The Panel also concluded that the additive is not irritant to skin, but irritant to the eyes and to the respiratory system. Due to the lack of data, the FEEDAP Panel could not conclude on the skin sensitisation potential of the additive. The FEEDAP Panel was not in the position to conclude on the efficacy of the additive for all poultry species and ornamental birds.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of l‐cystine as nutritional feed additive. The additive is authorised for use in all animal species (3c391). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed concluded that the use of the feed additive in animal nutrition remains safe for the target species, the consumers and the environment. As regards the safety for the user, l‐cystine is not an irritant to skin or eyes and is not a skin sensitiser. Exposure by inhalation of persons handling the additive cannot be excluded. The present application for the renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and therefore there is no need for reassessing the efficacy.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.460 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain is not genetically modified. Viable cells of the production strain were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. The use of l‐tryptophan (≥ 98%) produced with E. coli CGMCC 7.460 to supplement feed is safe for non‐ruminant species. There may be a risk for an increased production of toxic metabolites when unprotected tryptophan is used in ruminants. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns on the safety of the simultaneous oral administration of l‐tryptophan via water for drinking and feed due to possible amino acid imbalances and hygienic reasons. The use of l‐tryptophan produced with E. coli CGMCC 7.460 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive in combination with the high dusting potential may represent a risk of exposure by inhalation to endotoxins for users. The additive l‐tryptophan is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Levilactobacillus brevis DSM 21982 as a technological feed additive, silage additive, for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the additive should be considered as a skin and respiratory sensitiser. No conclusions can be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as a nutritional feed additive for use in feed and in water for drinking for all animal species. The production strain is non‐genetically modified, qualifies for the QPS approach to safety assessment when used for production purposes, is susceptible to the relevant antibiotics and contains no antimicrobial resistance genes of concern. No viable cells of the production strain were detected in the final product. The additive does not give rise to any safety concern regarding the production strain. l‐Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered safe for the target species, the consumer and the environment. Regarding the use in water, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reiterates its concerns over the safety for the target species of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. In the absence of data, the FEEDAP Panel is not in a position to conclude on the potential of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the high dusting potential, exposure by inhalation is likely. l‐Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered as an efficacious source of the essential amino acid l‐isoleucine for non‐ruminant animal species. For the supplemental l‐isoleucine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the selenised yeast (inactivated) Saccharomyces cerevisiae CCTCC M 2022402 (Plexomin® Se 3000, available in two forms: ‘granules’ and ‘micro’) as a nutritional feed additive for all animal species. Based on a tolerance–efficacy trial, the FEEDAP Panel concluded that the additive is safe for chickens for fattening at proposed conditions of use and this conclusion can be extrapolated to all animal species. In the absence of deposition data in all animal species and products, the FEEDAP Panel cannot conclude on the safety for the consumer. Plexomin® Se 3000 (granules) is dust‐free; therefore, the exposure through inhalation is unlikely. Plexomin® Se 3000 (micro) presents a risk by inhalation. Both forms of the additive (granules and micro) are considered as respiratory sensitisers. Due to the lack of data, no conclusions can be drawn on the dermal and eye irritation potential of Plexomin® Se 3000 (granules). Plexomin® Se 3000 (micro) is not irritant to the skin and the eyes. No conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. The use of the additive in animal nutrition is considered safe for the environment. The additive is an efficacious source of selenium in feedingstuffs for all animal species.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the additive based on fumonisin esterase (Free Yeast® F), produced with a genetically modified strain of Komagataella phaffii. The additive is categorised as a technological feed additive, for the reduction of the contamination of feed by mycotoxins and intended for use in all pigs species (piglets, pigs for fattening, sows and minor growing and reproductive porcine species). It was shown that the production strain and its recombinant genes are not present in the additive. The FEEDAP Panel concluded that the additive is safe for weaned and suckling piglets and pigs for fattening, and all minor growing porcine species up to 60 U/kg complete feed. No conclusions can be drawn on the safety of the additive in sows. The use of the additive in animal nutrition is of no concern for consumer safety. The additive is dust‐free, and therefore, respiratory sensitisation/irritation is unlikely. The additive is non‐irritant to the eyes and the skin. No conclusion could be made on skin sensitisation. The use of the additive as a feed additive is considered safe for the environment. The Panel concluded that the additive is efficacious as technological feed additive for the reduction of feed contamination by fumonisins, when used at the minimum recommended concentration of 60 U/kg. This conclusion can be extrapolated to all growing and reproductive pigs and other minor porcine species.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Enterococcus lactis DSM 22502 as a technological feed additive for all animal species. The applicant 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 regarding the safety and efficacy of the additive. The FEEDAP Panel concluded that E. lactis remains safe for all animal species, consumers and environment under the authorised conditions of use. Regarding the user safety, the Panel concluded that the additive is not irritating to the skin or eyes. No conclusions can be drawn on the potential of the additive to cause skin sensitisation, but it is considered to be a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening, chickens reared for laying, other poultry species for fattening or reared for laying, and ornamental birds. The additive is available in two formulations: Lactiferm WS200 and Lactiferm Basic 50. The FEEDAP Panel concluded that the use of the additive is safe for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying, and ornamental birds. The Panel also concluded that the use of the feed additive is safe for consumers, and the environment. Lactiferm WS200 is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It was not possible, however, to conclude on the irritancy potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both formulations of the additive to cause skin sensitisation. The efficacy studies submitted did not allow to draw a conclusion on the efficacy of the additive for the target species. Lactiferm® is considered compatible with the coccidiostats monensin sodium and decoquinate.

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

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of copper(II)‐betaine as a nutritional additive for all animal species and on the safety for the marine sediment when the additive is used in sea cages. The FEEDAP Panel concluded that the risk to the marine sediment is acceptable when the additive is used in sea cages. The additional statistical analysis of the results of the efficacy study already assessed in the previous opinion did not allow the Panel to conclude on the efficacy of the additive.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of zinc chloride hydroxide monohydrate as a nutritional feed additive for all animal species (3b609). The applicant reported changes in the production process and requested a change in the specification of the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) confirms that the use of the additive under the current authorised conditions of use is safe for the target species and the consumers. The use of the additive in animal nutrition at the proposed use levels for the terrestrial species and land‐based aquaculture systems is considered safe for the environment. The FEEDAP Panel cannot conclude on the safety of the additive for marine sediment compartment, when it is used in sea cages. The additive is an eye irritant, but not irritant to the skin and not a skin sensitiser. The exposure through inhalation is likely, but in the absence of data, the Panel is not in a position to conclude on the risk of exposure by inhalation. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) NCIMB 30139 as a technological additive for use in easy to ensile fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. The additive is not skin irritant, but no conclusions can be drawn on the skin sensitisation or eye irritation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

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.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese(II)‐betaine complex as a nutritional feed additive for all animal species and categories. Based on the tolerance study performed in chickens, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the maximum proposed level of manganese in feed; this conclusion was extrapolated to all animal species and categories at the corresponding maximum manganese levels in complete feed (100 mg Mn/kg feed for fish and 150 mg Mn/kg feed for all other animal species). The FEEDAP Panel concluded that the use of additive in animal nutrition does not represent a concern for consumer safety or for the environment. The additive is irritant to the eyes, but not irritant to skin. Owing to the presence of nickel the additive is considered to be a dermal and respiratory sensitiser. The Panel concluded that the additive is efficacious as a nutritional additive for all animal species under the proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for particles below 50 μm from 1% to 5%. The FEEDAP Panel considers that the proposed modifications do not introduce concern for the safety for the target species and that the additive remains safe for the target species and the consumers when used up to the maximum authorised levels. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land‐based aquaculture is considered safe under the proposed conditions of use. The data available do not allow the FEEDAP Panel to reach a conclusion on the safety of the additive for marine sediment when it is used in sea cages. The additive is not corrosive to skin, but is an eye and skin irritant. Due to the nickel presence, it is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Agal‐Pro BL/BL‐L®. The additive is a preparation of alpha‐galactosidase produced by a genetically modified strain of Saccharomyces cerevisiae (CBS 615.94) and endo‐1,4‐beta‐glucanase produced by a non‐genetically modified strain of Aspergillus niger (CBS 120604). It is intended to be used as a zootechnical additive (functional group: digestibility enhancers) in chickens for fattening in its solid and liquid forms (Agal‐Pro BL® and Agal‐Pro BL‐L®), and in minor poultry species for fattening and chickens reared for laying only in its solid form (Agal‐Pro BL®). 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 the target animals, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive is considered an irritant to the skin and eyes and a dermal sensitiser. Due to the proteinaceous nature of the active substances, it should be considered a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 25‐hydroxycholecalciferol as a feed additive for pigs and poultry. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive does not give raise to any safety concern regarding the production strain. Considering that the manufacturing process, the composition of the additive and its conditions of use have not been modified, the Panel considers that there is no evidence to reconsider the conclusions reached in the previous assessments. Therefore, the Panel concludes that 25‐OH‐D3 remains safe for the target species, the consumer and the environment under the existing conditions of the authorisation. The additive is not irritant to the skin or eyes but no conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. 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 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 endo‐β‐1,4‐xylanase (VTR‐xylanase) as a zootechnical feed additive for all avian species, piglets (suckling and weaned) and minor growing porcine species. VTR‐xylanase is available in a powder and a liquid form and is produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.371). 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 additive does not pose any safety concern regarding the production strain. VTR xylanase (powder/liquid) produced by Komagataella phaffii CGMCC 7.371 is safe for all avian species, piglets and minor growing porcine species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid and powder formulations of VTR‐xylanase are non‐irritant to eyes but should be considered skin sensitisers. No conclusions can be drawn on the potential of the final formulations of the additive to be irritant to skin. Due to the proteinaceous nature of the active substance, the additive is a respiratory sensitiser. The additive has the potential to be efficacious in all laying birds and piglets (suckling and weaned) from all Suidae at 2,000 U/kg and in all other avian species/categories at 1,000 U/kg feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 25‐hydroxycholecalciferol monohydrate produced with Saccharomyces cerevisiae CBS 146008 as a nutritional feed additive for all ruminants. The additive is already authorised for use with chickens for fattening, turkeys for fattening, other poultry and pigs. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not give raise to any safety concern regarding the production strain. The additive is safe for cattle for fattening and dairy cows at the maximum recommended use level of 0.1 mg 25‐OH‐D3/kg complete feed. This conclusion can be extended to other cattle categories and extrapolated to all ruminant species. The use of 25‐OH‐D3 in all ruminants under the proposed conditions of use is considered safe for the consumer. The additive is not irritant to the skin or eyes. No conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. The use of the additive under assessment at the recommended conditions of use is considered safe for the environment. 25‐OH‐D3 is an efficient source of vitamin D3 for all ruminants when used according to 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 l‐valine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (CGMCC 18932). l‐Valine is intended to be used in feed and water for drinking as a nutritional additive, functional group amino acids, their salts and analogues, for all animal species and categories. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that l‐valine produced by C. glutamicum CGMCC 18932 is considered safe for the target species when supplemented to the diet in appropriate amounts according to the nutritional needs of the target species. The use of l‐valine produced using C. glutamicum CGMCC 18932 in animal nutrition is considered safe for the consumer and for the environment. No conclusion could be drawn on the potential of l‐valine produced using C. glutamicum CGMCC 18932 to be irritant to the skin or eyes, or a dermal sensitiser due to the lack of data. The FEEDAP Panel concluded that the l‐valine produced by fermentation using C. glutamicum CGMCC 18932 is an efficacious source of the essential amino acid l‐valine for non‐ruminant nutrition. To be as efficacious in ruminants as in non‐ruminants, supplemental l‐valine requires protection against ruminal degradation. The FEEDAP Panel expressed concerns on the use of amino acids in water for drinking for hygienic reasons.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on concentrated liquid l‐lysine, l‐lysine monohydrochloride and concentrated liquid l‐lysine monohydrochloride produced by a genetically modified strain of Escherichia coli (NITE BP‐02917) as nutritional and as sensory (flavouring compound) feed additives for all animal species. In 2022, the FEEDAP Panel issued an opinion on the safety and efficacy of these products. In that assessment, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the genetically modified production organism in the products. The applicant provided supplementary data to exclude the presence of recombinant DNA derived from the production organism in the final products. Based on the new data provided, the FEEDAP Panel concluded that no DNA of the production strain E. coli NITE BP‐02917 was detected in concentrated liquid l‐lysine, l‐lysine monohydrochloride and concentrated liquid l‐lysine monohydrochloride.

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 the feed additive containing endo‐1,4‐β‐glucanase produced by Trichoderma citrinoviride IMI 360748 (Hostazym® C). The product is authorised as a zootechnical additive (functional group: digestibility enhancers) for use in chickens for fattening, minor poultry species for fattening and weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation for the use in those species/categories, and the extension of use to chickens reared for laying, turkeys reared for breeding, minor poultry species reared for laying or breeding, ornamental birds and suckling piglets. 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 Panel to reconsider previous conclusions that the additive is safe for the target species, the consumers, and the environment under the authorised conditions of use. This conclusion also applies to the target species for which a request for an extension of use is made. The additive is considered not a skin corrosive or eye irritant, but it should be considered a skin sensitiser. The Panel cannot conclude on the potential of the additive to be a skin irritant. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel considers that the additive has the potential to be efficacious at 500 CU/kg complete feed in all poultry for fattening, reared for laying or breeding, and ornamental birds, and at 350 CU/kg complete feed in piglets (weaned and suckling, for the period in which solid feed is given).

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on lactic acid produced by fermentation using a strain of Weizmannia coagulans (DSM 32789). The additive is intended to be used as a technological additive, functional group preservatives, in complete feed and water for drinking for all animal species except for fish. In a previous opinion, the FEEDAP Panel concluded that the production strain qualified for the qualified presumption of safety (QPS) approach for safety assessment. Uncertainty remained concerning the possible presence of viable cells and/or spores of the production strain in the final product, however, the presence of viable cells of a QPS strain would not raise safety concerns for the target species, humans, and the environment. The applicant has provided additional information in the form of a scientific report to support the absence of viable cells and/or spores in the final product. Based on the data provided, the FEEDAP Panel concluded that the final product contains no viable cells and/or spores of the production microorganism.

Abstract The vitamin B12 (in the form of cyanocobalamin) under assessment is produced by fermentation with Ensifer adhaerens CGMCC 19596 and it is intended to be used as a nutritional additive for all animal species. Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of cyanocobalamin, produced by fermentation with E. adhaerens CGMCC 19596. Cyanocobalamin produced by other strains of E. adhaerens is already authorised for use in animal species. ■■■■■ However no viable cells nor DNA of the production strain were detected in the additive. Therefore, cyanocobalamin produced by E. adhaerens CGMCC 19596 does not raise safety concerns as regards to the production strain. The FEEDAP Panel concluded that cyanocobalamin produced by fermentation with E. adhaerens CGMCC 19596 is considered safe for all animal species. The use of cyanocobalamin in animal nutrition is of no concern for consumer safety. Cyanocobalamin is non‐irritant to skin and non‐irritant to eyes. No conclusions could be drawn on the potential of the additive to be a skin sensitiser. The potential endotoxin activity of the additive is unlikely to represent a hazard for users. The use of the additive under assessment in animal nutrition is considered safe for the environment. Cyanocobalamin produced by E. adhaerens CGMCC 19596 is effective in meeting animal's nutritional requirements when administered via feed.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 as a nutritional feed additive for all animal species. The additive is produced by a genetically modified production strain. Although the production strain harbours some genes coding for resistance to antimicrobials, viable cells and DNA of the production strain were not detected in the final product. Therefore, the use of B. subtilis CGMCC 13326 to produce vitamin B2 does not raise safety concerns. The use of riboflavin 80% produced by B. subtilis CGMCC 13326 in animal nutrition does not represent a safety concern for the target species, consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential skin and eye irritation or potential toxicity by inhalation of the additive under assessment. Riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The additive under assessment is effective in covering the animals' requirements of vitamin B2 when administered via feed.

Abstract The additive RONOZYME® Hiphos (GT/L) contains 6‐phytase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae, it is currently authorised for poultry, pigs for fattening, weaned piglets and sows. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 22594 for A. oryzae DSM 33699. RONOZYME® Hiphos (GT/L), manufactured with the production strain A. oryzae DSM 33699, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its recombinant DNA were detected in an intermediate product representative of both final forms of the additive. RONOZYME® Hiphos (GT/L) was considered safe for poultry, pigs for fattening, weaned piglets and sows at the recommended inclusion levels of 500–4,000 FYT/kg complete feed. The use of RONOZYME® Hiphos GT and L manufactured with the production strain A. oryzae DSM 33699 raised no concerns for consumers. In the absence of data on the final formulations, the Panel could not conclude on the potential of the additive to be irritant to eyes or skin, or a skin sensitiser. Due to the proteinaceous nature of the active substance, the additive was considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33699 raises no safety concerns for the environment. The additive has the potential to be efficacious in poultry, pigs for fattening, weaned piglets and sows at 500 FYT/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sodium saccharin as a sensory feed additive (flavouring compound) for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening. In a previous assessment, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) could not conclude on the safety of the additive for the environment because concentrations of the additive or its degradation product 4‐hydroxysaccharin in groundwater above 0.1 μg/L were likely to occur. In addition, regarding user safety, sodium saccharin was considered to be potentially harmful by inhalation or by contact to skin and eyes. In the current opinion, the applicant restricted the use to suckling and weaned piglets and up to a use level of 5 mg/kg complete feed. In relation to the user safety, the additive was neither a skin or eye irritant, nor a dermal sensitiser. In the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be toxic by inhalation. Regarding the safety of the additive for the environment, the new conditions of use describe a maximum use level of 5 mg sodium saccharin/kg feed. The applicant indicated that a restriction to a lower use level due to environmental safety would be accepted and submitted an environment risk assessment based on a use level of 1.13 mg sodium saccharin/kg feed. This use level cannot be considered safe. The estimated use level that would result in a concentration in groundwater below 0.1 μg/L is of 0.022 mg sodium saccharin/kg feed. The available data do not allow to conclude on the potential effect of the degradation product 4‐hydroxysaccharin in ground water.

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 6‐phytase (VTR‐phytase) as zootechnical feed additive for all pigs and all avian species. The additive VTR‐phytase consists of 6‐phytase and it is available in solid and liquid forms. VTR phytase (liquid/solid) was produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.370). 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 additive does not pose any safety concern regarding the production strain. VTR phytase (liquid/solid) produced by Komagataella phaffii CGMCC 7.370 is safe for all Suidae and all avian species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid VTR phytase and powder VTR phytase are non‐irritant to skin or eyes but should be considered skin and respiratory sensitisers. The additive has the potential to be efficacious in laying hens at 1,000 U phytase/kg complete feed. The conclusion can be extrapolated to other birds for egg production or breeding. The FEEDAP Panel cannot conclude on the efficacy of all pigs or growing poultry species.

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 the product Huvezym® neXo 100 G/L containing an endo‐1,4‐beta xylanase, an endo‐1,4‐beta‐glucanase and a xyloglucan‐specific‐endo‐beta‐1,4‐glucanase produced by a non‐genetically modified strain of Trichoderma citrinoviride (DSM 33578) as a zootechnical additive for feed in all poultry species, ornamental birds and piglets (weaned and suckling). The information regarding the production strain did not allow to confirm its taxonomic identification. The batches used for the characterisation of the final formulations showed compliance with the minimum specifications of the additive in terms of enzyme activities but showed ratios between the enzymes lower than the ones specified for the additive. The FEEDAP Panel considered that the below‐described conclusions would apply to the final formulations of the additive as per specifications with xylanase:glucanase, xylanase:xyloglucanase and glucanase:xyloglucanase ratios of 15, 15 and 1, respectively. Based on the data available, the Panel concluded that the additive is safe for the target species, consumers and the environment. Huvezym® neXo 100 G (granulated form) is neither skin corrosive nor eye irritant but should be considered a potential skin sensitiser. Huvezym® neXo 100 L (liquid) is neither skin corrosive nor sensitising and it is not an eye irritant. Due to lack of data, no conclusions can be drawn on the skin irritation of the final formulations of the additive. Due to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The FEEDAP Panel concluded that the additive has the potential to be efficacious in chickens for fattening, chickens reared for laying and breeding, and all growing poultry and ornamental birds at the minimum intended level of 1,500 EPU, 100 CU and 100 XGU/kg complete feed. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens and weaned piglets.

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

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CGMCC 17927, when used as a nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine, and it was produced in two different forms: monohydrochloride (HCl) or sulfate salts. The production strain was genetically modified. Neither viable cells nor recombinant DNA of the production strain were detected in the final products. Therefore, the Panel concluded that the additives did not pose any safety concern regarding the production strain. The use of l‐lysine HCl and l‐lysine sulfate produced by the strain C. glutamicum CGMCC 17927 in supplementing feed to compensate for l‐lysine deficiency in feedingstuffs was safe for the target species. The FEEDAP Panel identified risks of nutritional imbalances and hygienic concerns for amino acids when administered simultaneously in feed and in water for drinking. The use of both forms of l‐lysine produced by fermentation using C. glutamicum CGMCC 17927 in animal nutrition was considered safe for the consumers and for the environment. Exposure of users through inhalation to l‐lysine HCl and l‐lysine sulfate produced with C. glutamicum CGMCC 17927 was considered very likely. In absence of data, the FEEDAP Panel could not conclude on the potential of both forms of the additive to be irritant for skin and eyes or to be dermal sensitisers. l‐Lysine HCl and l‐lysine sulfate were considered as efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of concentrated liquid l‐lysine, l‐lysine monohydrochloride and concentrated liquid l‐lysine monohydrochloride produced by Escherichia coli NITE BP‐02917 as nutritional and as sensory (flavouring compound) feed additives for all animal species. The production strain did not carry ■■■■■ antimicrobial resistance genes and no viable cells of the production strain were detected in the final products. ■■■■■ However, since no sequences of concern remained in the production strain, the potential presence of that DNA did not raise safety concerns. The use of the three forms of l‐lysine produced by E. coli NITE BP‐02917 in supplementing feed to compensate for l‐lysine deficiency in feedingstuffs was safe for the target species. This conclusion would also cover the use as a sensory additive. The FEEDAP Panel identified risks of nutritional imbalances and hygienic concerns for amino acids when administered simultaneously in feed and in water for drinking. The use of the three forms of l‐lysine produced by E. coli NITE BP‐02917 in animal nutrition was considered safe for the consumers and for the environment. Concentrated liquid l‐lysine, l‐lysine HCl and concentrated liquid l‐lysine HCl were not considered to have the potential to cause respiratory toxicity, or skin sensitisation. l‐Lysine HCl and concentrated liquid l‐lysine HCl were not considered skin and eye irritants. Concentrated liquid l‐lysine, due to its high pH, might be corrosive for skin and eyes. The three forms were considered an efficacious source of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. The three forms of the additive were also considered efficacious as feed flavouring compounds under 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 a preparation of carvacrol, thymol, d‐carvone, methyl salicylate and l‐menthol (Biomin® DC‐P) for all poultry species. The additive is authorised for use in feed for chickens for fattening, chickens reared for laying and minor poultry species reared to the point of lay. The safety and efficacy of the additive for those species have been previously evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive for all poultry species under the same conditions of use (recommended level ranging between 65 and 105 mg/kg complete feed). The FEEDAP Panel concluded that the additive Biomin® DC‐P is safe for poultry species for fattening or reared for laying, but in the absence of adequate data cannot conclude on the safety for laying/breeding birds. The use of Biomin® DC‐P in feed for all poultry species under the proposed conditions of use was considered safe for consumers and the environment. The FEEDAP Panel considered that exposure of users by inhalation is unlikely. In the absence of data, the Panel could not conclude on the effects of Biomin® DC‐P on skin and eyes. Biomin® DC‐P has the potential to be efficacious in poultry species for fattening or reared for laying when incorporated into feed at a minimum concentration of 65 mg/kg complete feed. In the absence of sufficient data, the Panel could not conclude on the efficacy for laying hens or for other poultry species for laying/breeding.

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