Safety and efficacy of a feed additive consisting of Bacillus velezensis PTA‐6507, B. velezensis NRRL B‐50013 and B. velezensis NRRL B‐50104 (Enviva® PRO 202 GT) for turkeys for fattening (Danisco Animal Nutrition)

[EN]Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the additive consisting of Bacillus amyloliquefaciens PTA-6507, B. amyloliquefaciens NRRL B-50013 and B. amyloliquefaciens NRRL B-50104 (trade name: Enviva® PRO 202 GT) for turkeys for fattening. The product under assessment is based on viable spores of three strains originally identified as B. amyloliquefaciens which, in the course of the current assessment, were reclassified as Bacillus velezensis. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agents was established. The active agents do not harbour acquired antimicrobial resistance genes and lack toxigenic potential and the capacity to produce aminoglycosides. Following the QPS approach, the three bacterial strains are presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, Enviva® PRO 202 GT is also considered safe for the target species, consumers and the environment. Enviva® PRO 202 GT is non-irritant to skin and eyes and is not a dermal sensitiser. Due to the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. In a previous opinion, it was concluded that Enviva® PRO 202 GT has a potential to be efficacious as a zootechnical additive in chickens for fattening at the recommended level of 7.5 × 107 CFU/kg complete feed. It is considered that conclusions on efficacy of Enviva® PRO 202 GT in chickens for fattening can be extrapolated to turkeys for fattening. Therefore, the FEEDAP Panel concludes that Enviva® PRO 202 GT has the potential to be efficacious in turkeys for fattening at 7.5 × 107 CFU/kg complete feed.S

Safety and efficacy of a feed additive consisting of l-histidine monohydrochloride monohydrate produced using Escherichia coli NITE SD 00268 for all animal species (Kyowa Hakko Europe GmbH)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on L-histidine monohydrochloride (HCl) monohydrate produced by fermentation with Escherichia coli (NITE SD 00268) when used as a nutritional additive or as a feed flavouring compound in feed for all animal species. The active substance of the additive is L-histidine. The production strain has been modified by conventional mutagenesis and it does not raise safety concerns. The additive under assessment 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. This conclusion would cover its use as flavouring compound. L-Histidine HCl monohydrate produced by E. coliNITE SD 00268, when used at the proposed conditions of use, is safe for the consumer and for the environment. L-Histidine HCl monohydrate produced using E. coliNITE SD 00268 is not a skin irritant. In the absence of data, it is not possible to conclude on the potential of the additive to be toxic by inhalation, irritant to eyes or a skin sensitiser. The additive L-histidine HCl monohydrate is regarded as an effective source of the amino acid L-histidine when used as a nutritional additive. 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. L-Histidine is efficacious as a flavouring compound. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Petroselinum crispum (Mill.) Fuss (parsley tincture) for use in all animal species (FEFANA asbl)

Following a request from the European Commission, EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a tincture derived from the fruit of Petroselinum crispum (Mill.) Fuss (parsley tincture) when used as a sensory feed additive for all animal species. The product is a solution, with a dry matter content of approximately 0.82%. The product contained 0.0198% polyphenols (of which 0.0085% were flavonoids), apiole (0.0083%), elemicin (0.0015%) and myristicin (0.0011%). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the parsley tincture is safe at the maximum proposed use levels of 200 mg/kg complete feed for horses and 50 mg/kg complete feed for all other animal species. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount which is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of parsley tincture up to the maximum proposed use levels in feed. Parsley tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to apiole, elemicin and myristicin cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of parsley tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of P. crispum and its preparations were recognised to provide flavour in food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary

Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525 (Axtra® XAP 104 TPT) for chickens for fattening, laying hens and minor poultry species (Genencor international B.V.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232, and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525, Axtra (R) XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the (ic) used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase. Moreover, the Panel could not conclude on the efficacy in laying hens. The applicant submitted some new information to address some of the limitations previously identified. Moreover, the applicant declared a change in the production strain of the protease, substituting B. subtilis ATCC SD-2107 for B. subtilis CBS 148232. The Panel concluded that the additive is safe for the target species at the recommended use level (1,000 xylanase U, 100 amylase U and 2,000 protease U per kg feed). The additive is safe for the consumers of food products obtained from animals fed with the additive and raises no concerns for the environment. The Panel could not conclude on the skin/eye irritancy potential of the additive nor on its dermal sensitisation potential. Owing to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level). Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens

Assessment of the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 21762 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 21762, as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but is considered a skin and respiratory sensitiser. 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. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority

Safety and efficacy of a feed additive consisting of l‐valine produced by Corynebacterium glutamicum CGMCC 7.366 for all animal species (Ningxia Eppen Biotech Co., Ltd.)

[EN] Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l-valine produced by fermentation using a non-genetically modified strain of Corynebacterium glutamicum (CGMCC 7.366). The additive is intended to be used in feed and water for drinking 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 concludes that l-valine produced using C. glutamicum CGMCC 7.366 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 C. glutamicum CGMCC 7.366 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 7.366 to be toxic by inhalation, irritant to the skin or eyes, or a dermal sensitiser due to the lack of data. The additive l-valine produced by fermentation using C. glutamicum CGMCC 7.366 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 rumenSIThe Panel wishes to acknowledge the contribution of Jaume Galobart, Yolanda Garc ıa Cazorla and Lucilla Gregoretti to this opinio

Assessment of the feed additive consisting of copper chelate of hydroxy analogue of methionine for all animal species for the renewal of its authorisation (Novus Europe S.A./N.V.)

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of copper chelate of hydroxy analogue of methionine (Mintrex (R) Cu) for all animal species. The FEEDAP Panel has delivered two opinions (in 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Copper chelate of hydroxy analogue of methionine' containing 18% copper, 79.5-81% (2-hydroxy-4-methylthio)butanoic acid (DL-methionine hydroxy analogue, HMTBa) and 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: >= 16% copper and >= 78% HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Mintrex((R))Cu is considered as a skin and eye irritant and a skin sensitiser; the risk of respiratory sensitisation is considered low. The present application 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. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority

Safety and efficacy of a feed additive consisting on Ligilactobacillus animalis ATCC PTA‐6750 (formerly Lactobacillus animalis) for all animal species (Chr. Hansen A/S)

[EN] 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 additive consisting of Ligilactobacillus animalis (formerly known as Lactobacillus animalis) ATCC PTA-6750 when used as a technological additive (acidity regulator, preservative and hygiene condition enhancer) in feed and water for drinking for all animal species. The product is intended for use as a single strain at a minimum inclusion level of 5 × 106 CFU/L or CFU/kg in water, liquid and dry feeds. No minimum inclusion level is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species L. animalis is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. The Panel is not in the position to conclude on the efficacy of L. animalis ATCC PTA-6750 when used in animal nutrition as an acidity regulator, preservative or hygiene condition enhancer due to lack of data. The studies provided showed that L. animalis ATCC PTA-6750 when used in combination with Propionibacterium freudenreichii ssp. shermanii ATCC PTA-6752 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditionsSIThe Panel wishes to acknowledge the contribution of Yolanda Garc ıa Cazorla to this opinio

Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase (ECONASE® XT) produced by Trichoderma reesei CBS 140027 as a feed additive for piglets (weaned), pigs for fattening, chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding and minor poultry species (Roal Oy)

[EN] Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ECONASE® XT (endo-1,4-β-xylanase) produced by a genetically modified strain of Trichoderma reesei (CBS 140027) as a zootechnical feed additive for piglets (weaned), pigs for fattening, chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding and minor poultry species. The recipient strain and the production strain T. reesei CBS 140027 are considered safe. The additive is safe for chickens for fattening and weaned piglets at the maximum recommended doses (16,000 and 24,000 BXU/kg feed, respectively) with a wide margin of safety (100-fold and 50-fold, respectively). These conclusions are extended to chickens reared for laying and to pigs for fattening at 16,000 and 24,000 BXU/kg feed, respectively. The additive is safe for turkeys for fattening or reared for breeding at 16,000 BXU/kg feed. The FEEDAP Panel cannot conclude on the safety of the additive for laying hens and for minor poultry species for laying at the proposed conditions of use. The information provided does not allow to conclude on the safety of the use of ECONASE XT® P/L produced by T. reesei CBS 140027 in animal nutrition for the consumers. The use of the additive under assessment in animal nutrition does not raise safety concerns for the environment. ECONASE® XT L is non-irritant to the skin or to the eyes. In absence of data, the FEEDAP Panel cannot conclude on the potential of the solid product to be irritant to skin and eyes and on the potential of the additive in all forms to be a dermal sensitiser. All forms of the additive should be considered as respiratory sensitisers. All forms of the additive are considered efficacious at the minimum recommended levels for the target speciesSIThe Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last name): Konstantinos Sofianidi

Safety of a feed additive consisting of sodium saccharin for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening (FEFANA asbl)

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 mu g/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 mu g/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