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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation regarding the maximum inclusion level of a feed additive consisting of nonanoic acid for all pigs and poultry species. Nonanoic acid is currently authorised for use as a sensory additive (functional group: flavouring compounds) for all animal species at a recommended maximum content of 5 mg/kg complete feed. The applicant is requesting a modification of the authorisation to increase the recommended maximum content of the active substance from 5 to 100 mg/kg complete feed for all poultry and pig species. In support of the safety of the additive at the new proposed level, the applicant provided tolerance trials in the target species. The FEEDAP Panel concludes that nonanoic acid is safe for all growing poultry species and Suidae at 100 mg/kg feed. The Panel cannot conclude on the safety of the new proposed level (100 mg/kg complete feed) for laying hens, turkeys for breeding, minor poultry species for laying/breeding and reproductive Suidae. However, FEEDAP Panel considered that nonanoic acid is safe at 10 mg/kg complete feed in laying hens, turkeys for breeding, minor poultry species for laying/breeding and 20 mg/kg complete feed for reproductive Suidae. The use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for the consumer and the environment. Due to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant neither a dermal nor respiratory sensitiser. No further demonstration of efficacy is necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Pediococcus acidilactici CNCM I‐4622 as a zootechnical additive (functional group: physiological condition stabilisers) for all insects. The active agent used in the additive is already authorised for use in all animal species as a technological additive, and as a zootechnical additive in all Suidae species for fattening and for breeding, other than sows, all avian species, all fish species and all crustaceans. The active agent has been identified as a strain of P. acidilactici and consequently meets the qualifications required by the qualified presumption of safety (QPS) approach. The use of the additive is considered safe for all insect species, consumers and the environment. The additive is considered non‐irritant to skin and eyes but a respiratory sensitiser. No conclusions can be drawn regarding its skin sensitisation potential. In the absence of adequate data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive as a physiological condition stabiliser for honeybees nor for all insect species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 41 compounds to provide a Herbal flavour and belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fourteen out of the 41 compounds were tested in tolerance studies in chickens for fattening, piglets, cattle for fattening and Atlantic salmon. No adverse effects were observed in the tolerance studies at 10‐fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 14 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 27 compounds, read‐across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 27 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer and the environment from the use of the 41 compounds up to the maximum proposed use level in feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively. The additives are intended for use with all types of fresh materials and for all animal species at a proposed minimum concentration of 1 × 107 colony forming units (CFU) of E. faecium ATCC 53519/kg forage or 5 × 106 CFU of E. faecium ATCC 55593/kg forage. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy since the dry matter content of the ensiled materials at the end of the experiments was not corrected for volatiles, which led to an unreliable estimation of the dry matter loss, and the lack of positive effects on any of the other parameters. The supplementary information submitted by the applicant included updated data on the pH values and the dry matter loss corrected for volatiles. However, the estimation of the dry matter loss corrected for volatiles was wrongly calculated and thus, was not considered for the assessment of the efficacy of the additive. Considering the lack of effect on any other fermentation parameter, the Panel could not conclude on the efficacy of the additive to improve the production of silage under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 27 compounds to provide a milky‐vanilla flavour belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fifteen of the 27 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. No adverse effects were observed in the tolerance studies at 10‐fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 15 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 12 compounds, read‐across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 12 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer from the use of the 27 compounds up to the highest levels considered safe for target animals. No new data were submitted on the safety for the user that would allow the FEEDAP Panel to change its previous conclusion for 5‐methylhept‐2‐en‐4‐one [07.139], 5‐methylfurfural [13.001] and 4‐phenylbut‐3‐en‐2‐one [07.024]. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives to improve ensiling of forages consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively, for all animal species. The additives are intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 107 colony forming units (CFU) of E. faecium ATCC 53519/kg forage or 5 × 106 CFU of E. faecium ATCC 55593/kg forage, respectively. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy owing to the lack of sufficient evidence for an improvement on the nutrient preservation during the ensiling process. The new data submitted by the applicant as supplementary information provided not enough weight of evidence on the effects of the additives on the ensiling of easy, moderately difficult and difficult to ensile material, and therefore, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives to improve ensiling of forages consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) strains ATCC 55058 and ATCC 55942, respectively, for all animal species. Both additives are intended for use with all forages and for all animal species at a proposed minimum concentration of 5 × 106 colony forming units (CFU)/kg forage. In two previous opinions, the FEEDAP Panel could not conclude on their efficacy due to the absence of any significant evidence of nutrient preservation. Based on three new efficacy studies provided by the applicant as supplementary information, the FEEDAP Panel concluded that the addition of L. plantarum strains ATCC 55058 or ATCC 55942, have the potential to improve the ensiling process by reducing protein degradation in all type of forages as indicated by the reduction of ammonia production. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and the efficacy of the feed additives cellulase (produced by Aspergillus niger CBS 120604), beta‐glucanase (produced by Aspergillus neoniger MUCL 39199) and xylanases (produced by Trichoderma citrinoviride MUCL 39203 and CBS 614.94) as silage additives for all animal species. In 2018, the FEEDAP Panel evaluated 11 enzymes to be used as silage additives. In that opinion, the additives, including the production strains, were characterised in full and their safety and efficacy were evaluated. However, the Panel could not conclude on the identification of the production strains of the xylanase produced by the strain with deposit number MUCL 39203 (product referred as to J) and the glucanase produced by strain with deposit number MUCL 39199 (product referred as to L). The Panel could not conclude either on the efficacy of the products J, L as well as for the cellulase produced by the strain with deposit number CBS 120604 (product referred as to H) and the xylanase produced by the strain with deposit number CBS 614.94 (product referred to as K). The newly submitted information showed that the species for the xylanase produced by the strain with deposit number MUCL 39203 (product J), should be changed into Trichoderma citrinoviride, and that the species of the production strain for the glucanase produced by the strain with deposit number MUCL 39199 (product L), should be changed into Aspergillus neoniger. The Panel concluded that the four additives have the potential to reduce the protein degradation during the ensiling process when added at the corresponding inclusion levels in different types of forages. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganous lysinate sulfate as nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was assigned to this mandate. Based on the results of a tolerance study, the FEEDAP Panel concluded that manganous lysinate sulfate is safe for chickens for fattening when used up to the current maximum authorised levels of total manganese in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum manganese levels in complete feed authorised in the EU. The FEEDAP Panel concluded that the use of manganous lysinate sulfate in animal nutrition at the maximum manganese levels authorised for the animal species poses no concern to the safety of consumers and the environment. The Panel also concluded that manganous lysinate sulfate poses a risk to users by inhalation, is irritant to eyes and skin and should be considered a dermal sensitiser. Based on the results of a bioequivalence study, the FEEDAP Panel concluded that manganous lysinate sulfate is considered efficacious for chickens for fattening as a nutritional additive. This conclusion was extrapolated to all animal species and categories. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5'-guanylate produced by fermentation with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The additive does not raise safety concerns under the proposed conditions of use for the target species, consumers the users and the environment. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) expressed reservations on the use of the additive in water for drinking due to concerns on its impact on hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed. [ABSTRACT FROM AUTHOR]

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 of 31 compounds belonging to different chemical groups, when used as sensory additives in feed for all animal species. Twenty‐two out of the 31 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. For the remaining nine compounds, read across from structurally similar compounds was proposed. No adverse effects were observed in the tolerance studies at 10‐fold the intended level. The FEEDAP Panel concluded that the 22 compounds are safe for these species at the proposed use level and conclusions were extrapolated to all animal species for all the compounds except for α‐damascone [07.134]. In the absence of data that would allow the FEEDAP Panel to rule out the genotoxicity concern, the FEEDAP Panel cannot extend the conclusions for α‐damascone [07.134] to all animal species and cannot conclude on the safety for the consumer, the user and the environment. No safety concern would arise for the consumer from the use of the remaining 30 compounds up to the highest levels considered safe for target animals. The revised maximum safe levels for the 30 compounds are not expected to further impact on the previous conclusions on user safety. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds except β‐damascone [07.083] and (E)‐β‐damascone [07.224], for which in the absence of ecotoxicity data, the FEEDAP Panel cannot conclude on the safety for the terrestrial compartments. For the marine environment, the safe use level for 2‐methyl‐1‐phenylpropan‐2‐ol [02.035], α‐irone [07.011], β‐damascone [07.083] and (E)‐β‐damascone [07.224], phenethyl isovalerate [09.466], 4‐(p‐hydroxyphenyl) butan‐2‐one [07.055] and 2‐isopropyl‐4‐methylthiazole [15.026] is confirmed to be 0.05 mg/kg. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation with a non‐genetically modified strain of Escherichia coli KCCM 10534 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli KCCM 10534 is safe for the production of l‐tryptophan and it was not detected in the final product. The use of l‐tryptophan produced using E. coli KCCM 10534 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non‐ruminant target species. There may be a risk for an increased production of toxic metabolites when unprotected tryptophan is used in ruminants. The FEEDAP Panel 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. The use of l‐Tryptophan produced by E. coli KCCM 10534 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. The additive under assessment is considered not toxic by inhalation, it is not a skin or eye irritant and is not a skin sensitiser. The endotoxin activity of the additive and its dusting potential indicate a risk by inhalation for the users. The product l‐tryptophan is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. In order to be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation. [ABSTRACT FROM AUTHOR]

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by genetically modified strains of Corynebacterium glutamicum (NRRL‐B‐67439 or NRRL B‐67535). They are intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains C. glutamicum strains NRRLB‐67439 or NRRL B‐67535; nor their recombinant DNA were detected in the final products. Therefore, those products do not pose any safety concern associated with the genetic modification of the production strains. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l‐lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535. Concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535, due to its high pH (10.7 and 10.9, respectively) is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered as efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐histidine monohydrochloride (HCl) monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80179 when used as a nutritional additive (amino acid) and as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is not genetically modified. No viable cells of the production strain were detected in the final product. The use of l‐histidine monohydrochloride monohydrate produced by fermentation using C. glutamicum KCCM 80179 is safe for the target species when used as a nutritional additive to supplement the diet in appropriate amounts to cover the requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. This conclusion would also cover the use as a sensory additive. l‐Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 supplemented at levels appropriate for the requirements of species and life stage is considered safe for the consumer. l‐Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 is not irritant to skin, is mildly irritant to eyes, and it is not a skin sensitiser. The additive does not pose a risk to users by inhalation. The use of l‐histidine HCl monohydrate produced by C. glutamicum KCCM 80179 in animal nutrition is not expected to represent a risk to the environment. l‐Histidine HCl monohydrate is considered an efficacious source of the essential amino acid l‐histidine for non‐ruminant animal species. For the supplemental l‐histidine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. It is also considered efficacious as a feed flavouring compound under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

l‐Arginine is an amino acid that is conditionally essential for mammalian neonates, some strict carnivores, birds and fish. The subject of this opinion is a request for renewal of authorisation of l‐arginine produced by a strain of Corynebacterium glutamicum. The strain designation has changed to its new deposition number, NITE SD 00285, but the strain is otherwise unchanged from the previous opinion. It is not genetically modified and possesses no antibiotic resistance of safety concern. Minor changes in downstream processing following fermentation have been made. The FEEDAP Panel notes that two out of five batches did not meet the specification of the current authorisation (minimum 98% on a dry matter basis). The FEEDAP Panel concludes that l‐arginine produced by fermentation to C. glutamicum NITE SD 00285 remains safe for the target species, consumers of products from animals fed the additive and the environment under the approved conditions of authorisation. The additive is considered as irritant to skin, corrosive to eyes and poses a risk by inhalation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (KCCM 80176) when used as a nutritional additive in feed and water for drinking for all animal species. Viable cells of the production strain and its recombinant DNA were not detected in the additive. l‐Tryptophan manufactured by fermentation using C. glutamicum KCCM 80176 does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l‐tryptophan produced using C. glutamicum KCCM 80176 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non‐ruminant target species and in ruminants when a rumen‐protected form is used. The use of l‐tryptophan produced by C. glutamicum KCCM 80176 in animal nutrition presents no safety concerns to consumers of animal products. l‐Tryptophan produced by C. glutamicum KCCM 80176 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. l‐Tryptophan produced by C. glutamicum KCCM 80176 is safe for the environment. l‐Tryptophan produced by C. glutamicum KCCM 80176 is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. If l‐tryptophan is intended for use in ruminants, it should be protected from ruminal degradation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation using Escherichia coli KCCM 80135 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain and its recombinant DNA were not detected in the additive. l‐Tryptophan produced by fermentation with E. coli KCCM 80135 does not raise any safety concern with regard to the genetic modification of the production strain. The use of l‐tryptophan produced using E. coli KCCM 80135 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non‐ruminant target species. Using unprotected forms of tryptophan in ruminants can be a risk. The use of l‐tryptophan produced by fermentation using E. coli KCCM 80135 in animal nutrition presents no safety concerns to consumers of animal products. l‐Tryptophan produced by E. coli KCCM 80135 is not toxic by inhalation. The additive is not an irritant to skin and eyes, and it is not a skin sensitiser. The additive under assessment is considered safe for the environment. It is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. If the additive l‐tryptophan is intended for use in ruminants, it should be protected from ruminal degradation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced using Corynebacterium glutamicum KCCM 10227 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l‐lysine. l‐lysine HCl and concentrated liquid l‐lysine (base) produced by the strain C. glutamicum KCCM 10227 do not represent a risk for the target species, the consumer and the environment. l‐lysine HCl produced by C. glutamicum KCCM 10227 is hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. Concentrated liquid l‐lysine (base) produced by C. glutamicum KCCM 10227 is hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l‐lysine HCl and concentrated liquid l‐lysine (base) are considered as efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐leucine produced by fermentation with Escherichia coli NITE BP‐02351 when used as nutritional additive or as feed flavouring compound in feed and water for drinking for all animal species. The product under assessment is l‐leucine produced by fermentation with a genetically modified strain of E. coli (NITE BP‐02351). The production strain and its recombinant DNA were not detected in the final products. l‐Leucine, manufactured by fermentation with E. coli NITE BP‐02351, does not give rise to any safety concern to the production strain. The use of l‐leucine produced with E. coli NITE BP‐02351 is safe for the target species when used to supplement the diet in appropriate amounts. It is safe at the proposed use level of 25 mg/kg when used as flavouring compound for all animal species. The use of l‐leucine produced by fermentation with E. coli NITE BP‐02351 in animal nutrition raises no safety concerns for consumers of animal products. The additive is not irritating to the skin or eyes and is not a skin sensitiser. There is a risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of l‐leucine produced by E. coli NITE BP‐02351 as feed additive does not represent a risk to the environment. The additive l‐leucine produced by E. coli NITE BP‐02351 is regarded as an effective source of the amino acid l‐leucine when used as nutritional additive. For the supplemental l‐leucine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. It is also considered efficacious as feed flavouring compound under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). Owing to the uncertainties regarding the possible genetic modification of the strain used to obtain the production strain C. glutamicum CCTCC M 2015595 and on the possible presence of viable cells and DNA of the production strain in the final product, the FEEDAP Panel cannot conclude on the safety of the additives l‐lysine HCl and l‐lysine sulfate produced with C. glutamicum CCTCC M 2015595 for the target species, the consumers, the users and the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via water for drinking. In the absence of data, the FEEDAP Panel cannot conclude on the safety of the additive for the user. The products under assessment are considered efficacious sources of the amino acid l‐lysine for all animal species. For these products to be as efficacious in ruminants as in non‐ruminant species, they require protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation with Escherichia coli CGMCC 11674 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain did not raise safety concerns. The FEEDAP Panel cannot conclude on the safety of l‐tryptophan produced by E. coli CGMCC 11674 for the target species and for the consumer due to the tryptophan‐related impurities such as 1,1'‐ethylidene‐bis‐l‐tryptophan (EBT). The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of l‐tryptophan via water for drinking and feed. Using unprotected forms of tryptophan in ruminants can be a risk. The FEEDAP Panel cannot conclude on the dermal or ocular irritation and skin sensitisation of l‐tryptophan produced by E. coli CGMCC 11674. The additive poses a risk by inhalation from the exposure to endotoxins for people handling the additive. The use of l‐tryptophan produced by E. coli CGMCC 11674 in animal nutrition does not pose a risk to the environment. The additive under assessment is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. If the product l‐tryptophan is intended for use in ruminants, it should be protected from ruminal degradation. [ABSTRACT FROM AUTHOR]

The product subject of this assessment is l‐valine produced by fermentation with a strain of Corynebacterium glutamicum (CGMCC 11675). It is intended to be used in feed and water for drinking for all animal species and categories. Owing to the uncertainties regarding the possible genetic modification of the original production strain, the FEEDAP Panel cannot conclude on the safety of the additive l‐valine produced with C. glutamicum CGMCC 11675 for the target species, the consumers, the users and the environment. The FEEDAP Panel has concerns on the safety for the target animals of the simultaneous oral administration of valine‐containing additives via feed and water for drinking. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l‐valine produced with C. glutamicum CGMCC 11675 to be toxic by inhalation, irritant to skin or eyes, or on its potential to be a dermal sensitiser. The product is considered an efficacious source of the amino acid l‐valine for all animal species. The supplemental l‐valine requires protection against rumen degradations in order to be as efficacious in ruminant as in non‐ruminant species. [ABSTRACT FROM AUTHOR]

Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has requested for the authorisation in new species/categories. The Panel considered that the new use would not introduce hazards that have not already been considered. Therefore, it was concluded that the additive is safe for the consumers and the environment. Considering the safety for the user, the Panel concluded that the additive, in either form, is not toxic by inhalation or irritant for skin or eye but it is considered a potential respiratory sensitiser. The Panel could not conclude on the dermal sensitisation potential of the additive. In a trial with weaned piglets, the animals tolerated well a 200‐fold the level recommended in feed by the applicant; therefore, the Panel concluded that the additive is safe for weaned piglets, pigs for fattening and minor porcine species at the recommended level. Based on the data provided to support the efficacy of the additive in weaned piglets and pigs for fattening, the Panel concluded that the additive has the potential to be efficacious at the recommended level in those species/categories. The conclusions on the safety and efficacy for weaned piglets and pigs for fattening were extrapolated to minor porcine species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ when used as nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l‐threonine produced by fermentation with a genetically modified strain of C. glutamicum (■■■■■). The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with C. glutamicum, ■■■■■ does not give rise to any safety concern with regard to the production strain. l‐Threonine produced using C. glutamicum ■■■■■ is considered safe for the target species. The FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of l‐threonine via water for drinking and feed. l‐Threonine produced using C. glutamicum ■■■■■ is safe for the consumer. The additive is not a skin or eye irritant and is not a skin sensitiser. Although the workers can be exposed by inhalation, the results of an acute inhalation study showed that risk of adverse effects by inhalation is low. l‐Threonine produced using C. glutamicum ■■■■■ is safe for the environment. The product under assessment is considered an efficacious source of the amino acid l‐threonine for all animal species. For l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation with a genetically modified strain of Escherichia coli CGMCC 7.248 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli CGMCC 7.248 and its recombinant DNA were not detected in the final product. The product l‐tryptophan, manufactured by fermentation with E. coli CGMCC 7.248, does not give rise to any safety concern with regard to the genetic modification of the production strain. l‐Tryptophan produced by E. coli CGMCC 7.248 is safe for non‐ruminant target species. The use of unprotected l‐tryptophan in ruminant feed should be avoided. l‐Tryptophan produced by fermentation by E. coli CGMCC 7.248 is safe for the consumer. The level of endotoxins present in the product and its dusting potential indicate an inhalation risk for the user. l‐Tryptophan produced by E. coli CGMCC 7.248 is not a skin or eye irritant but it is a dermal sensitiser. The use of l‐tryptophan produced by E. coli CGMCC 7.248 in animal nutrition does not pose a risk to the environment. The product under assessment is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. For the supplemental l‐tryptophan to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic modification does not introduce any safety concern and no introduced antibiotic resistance genes remain in its genome. Even if uncertainty remains concerning the absence/presence of the production strain and/or its recombinant DNA in the final products, these would not raise safety concerns. The liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP or C. glutamicum KCCM 11117P; and l‐lysine HCl produced by C. glutamicum NRRL B‐50547 are considered safe for the target species, consumers and the environment. Regarding the safety for the user, concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP, C. glutamicum NRRL B‐50547 or C. glutamicum KCCM 11117P are not irritant to skin or eyes and they are not skin sensitisers. l‐Lysine HCl is not hazardous by inhalation. The use of C. glutamicum DSM 24990 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users or the environment. No negative effects are to be expected for the target species within the proposed inclusion levels of 0.5–30 g lysine sulfate/kg complete feed provided that the total S intake complies with the recommendations of established scientific bodies. The use of C. glutamicum KCCM 10227 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users and the environment with regard to antimicrobial resistance. No negative effects are to be expected for the target species within common inclusion levels provided that the total S intake complies with the recommendations of established scientific bodies. [ABSTRACT FROM AUTHOR]

The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the genetic modification of the production strain. l‐Threonine produced using E. coli CGMCC 7.232 is considered safe for the target species. The FEEDAP Panel has concerns regarding the safety of the simultaneous administration of l‐threonine via water for drinking and feed. l‐Threonine produced using E. coli CGMCC 7.232 is safe for the consumer. In absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and eyes or to be a skin sensitiser. There is a risk from the inhalation exposure to endotoxins for persons handling the additive. l‐Threonine produced using E. coli CGMCC 7.232 is safe for the environment. The product under assessment is considered an efficacious source of the amino acid l‐threonine for all animal species. For l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]