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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

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) IMI 507028 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 109 colony forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 109 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.

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

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

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 12837 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.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) IMI 507027 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 109 colony forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 109 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.

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 Pediococcus acidilactici DSM 16243 as a technological additive 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 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 Pediococcus acidilactici DSM 16243 is not irritant to skin and eyes but 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.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) IMI 507028 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 109 colony forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 109 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.

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 12836, 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.

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 12837 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.

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 rumen.

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 species.

The feed additive under assessment (trade name: Miya‐Gold® S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya‐Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya‐Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya‐Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya‐Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.

Ronozyme® ProAct is the trade name of the feed additive under assessment and contains serine protease produced by a genetically modified strain of Bacillus licheniformis. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Ronozyme® ProAct when used as a zootechnical additive for chickens for fattening. The additive is available in coated thermotolerant granulated and liquid forms (Ronozyme® ProAct CT/L). The production strain and its recombinant DNA were not detected in an intermediate concentrated product used to produce the final formulations. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the FEEDAP Panel concluded that the additive is safe for chickens for fattening. The FEEDAP Panel concluded that the use of Ronozyme® ProAct CT/L as a feed additive gives rise to no concern for consumers and for the environment. The additive, in either form, is not an eye irritant but should be considered a skin irritant. In the absence of data, no conclusions on the skin sensitisation potential can be reached. Owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The FEEDAP Panel also concluded that the additive has the potential to be efficacious at 15,000 PROT/kg compound feed for chickens for fattening.

The feed additive under assessment (trade name: Miya‐Gold® S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya‐Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya‐Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya‐Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya‐Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.

Ronozyme® ProAct is the trade name of the feed additive under assessment and contains serine protease produced by a genetically modified strain of Bacillus licheniformis. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Ronozyme® ProAct when used as a zootechnical additive for chickens for fattening. The additive is available in coated thermotolerant granulated and liquid forms (Ronozyme® ProAct CT/L). The production strain and its recombinant DNA were not detected in an intermediate concentrated product used to produce the final formulations. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the FEEDAP Panel concluded that the additive is safe for chickens for fattening. The FEEDAP Panel concluded that the use of Ronozyme® ProAct CT/L as a feed additive gives rise to no concern for consumers and for the environment. The additive, in either form, is not an eye irritant but should be considered a skin irritant. In the absence of data, no conclusions on the skin sensitisation potential can be reached. Owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The FEEDAP Panel also concluded that the additive has the potential to be efficacious at 15,000 PROT/kg compound feed for chickens for fattening.

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 Propionibacterium freudenreichii ssp. shermanii ATCC PTA‐6752 when used as technological additive (acidity regulator) in dry feed at a minimum inclusion level of 2 × 109 colony‐forming units (CFU)/kg and in complete or complementary liquid feed for all animal species at a minimum concentration of 1 × 109 CFU/L. No minimum concentration is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species P. freudenreichii is considered by EFSA to be eligible for the qualified presumption of safety approach to safety assessment. 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 animals, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the additive, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. No conclusions could be drawn on the efficacy of the additive when used alone as an acidity regulator in feed due to lack of data. The studies provided showed that P. freudenreichii ssp. shermanii ATCC PTA‐6752 when used in combination with Ligilactobacillus animalis ATCC PTA‐6750 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditions.

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 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l‐threonine produced using a genetically modified strain of E. coli CGMCC 13325. The Panel notes that three out of five batches of the additive do not comply with the minimum specification of 98.5% l‐threonine on a dry matter basis proposed by the applicant. 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 use of l‐threonine produced using E. coli CGMCC 13325 in supplementing feed to compensate for threonine deficiency in feedingstuffs is 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 l‐threonine produced by fermentation using E. coli CGMCC 13325 in animal nutrition is considered safe for the consumers and for the environment. There is a risk from the inhalation exposure to endotoxins for persons handling the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l‐threonine produced using E. coli CGMCC 13325 to be a skin or eye irritant or a skin sensitiser. The additive under assessment is regarded as an effective source of the amino acid l‐threonine for all non‐ruminant species. For the supplemental l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

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 6‐phytase produced by Trichoderma reesei CBS 122001 (brand name: Finase® EC). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel concludes that the additive remains safe for poultry for fattening, breeding and laying, and all pigs, the consumer and the environment under the authorised conditions of use. Regarding user safety, the Panel reiterates that the additive is not a skin or eye irritant or sensitiser but should be considered a potential respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. These conclusions also apply to the new proposed liquid formulation Finase® EC 5 L.

Natugrain® TS/TS L is the trade name of the feed additive under assessment and contains endo‐1,4‐β‐xylanase and endo‐1,4‐β‐glucanase produced by genetically modified strains of Aspergillus niger. The product is currently authorised for use as a feed additive for poultry species, ornamental birds, weaned piglets and pigs for fattening. This scientific opinion concerns the renewal of the authorisation of this additive for poultry species, ornamental birds and weaned piglets. The applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment under the authorised conditions of use. The additive is safe for the target species for which the renewal of the authorisation is requested, the consumers and the environment. The additive is a potential skin and a 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.

The vitamin B12 (in the form of cyanocobalamin) under assessment is produced by fermentation with a genetically modified strain of Ensifer adhaerens and it is intended to be used as a nutritional additive for all animal species. In 2018, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers and the environment due to uncertainties on the safety of the production strain and the resulting product. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, the additive was considered to pose a risk to user safety. The applicant provided supplementary data on the identity of the production strain, its susceptibility to antibiotics and toxigenic potential, as well as on the absence of cells and recombinant DNA of the production strain in the final product. The production strain is not expected to produce any toxic compound during fermentation but harbours antimicrobial resistance genes. However, viable cells and recombinant DNA of the strain were not detected in the most concentrated form of the additive. With this new information, the FEEDAP Panel concluded that vitamin B12 produced by E. adhaerens CNCM I‐5541 (identified as SCM 2034 in the previous opinion) is safe for all animal species, the consumers and the environment. The applicant did not provide new evidence that would lead the FEEDAP Panel to reconsider previous conclusions regarding the safety for the user.

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 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l‐threonine produced using a genetically modified strain of E. coliCGMCC 13325. The Panel notes that three out of five batches of the additive do not comply with the minimum specification of 98.5% l‐threonine on a dry matter basis proposed by the applicant. 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 use of l‐threonine produced using E. coliCGMCC 13325 in supplementing feed to compensate for threonine deficiency in feedingstuffs is 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 l‐threonine produced by fermentation using E. coliCGMCC 13325 in animal nutrition is considered safe for the consumers and for the environment. There is a risk from the inhalation exposure to endotoxins for persons handling the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l‐threonine produced using E. coliCGMCC 13325 to be a skin or eye irritant or a skin sensitiser. The additive under assessment is regarded as an effective source of the amino acid l‐threonine for all non‐ruminant species. For the supplemental l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.

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 Calsporin® (Bacillus velezensis DSM 15544) as a zootechnical additive for weaned piglets. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis. During the course of the current assessment, the active agent has been reclassified as Bacillus velezensis DSM 15544. B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and the compliance with the other qualifications confirmed. Therefore, B. velezensis DSM 15544 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Calsporin® is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. The additive is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. The 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.

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 Correlink™ ABS1781 Bacillus subtilis (hereafter designated as Correlink™ ABS1781) when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and minor growing poultry species. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis, which in the course of the current assessment, was reclassified as Bacillus velezensis NRRL B‐67259. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NRRL B‐67259 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Correlink™ ABS1781 is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. Correlink™ ABS1781 is not irritant to skin and eyes or a skin sensitiser but is a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of Correlink™ ABS1781 for the target species due to lack of data.

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 (base) and l‐lysine monohydrochloride (HCl) produced using Corynebacterium casei KCCM 80190 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l‐lysine. The production strain is genetically modified. It does not carry acquired antimicrobial resistance genes and no viable cells of the production strain nor its DNA were detected in the final products. Therefore, the additives do not pose any safety concern regarding the genetic modifications. Concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. casei KCCM 80190 do not represent a risk for the target species, the consumer and the environment. From the results of studies on the safety for the user of concentrated liquid l‐lysine (base) and l‐lysine HCl produced by a different production strain, it was possible to conclude on the safety for the user of the products under assessment. Concentrated liquid l‐lysine (base) produced by C. casei KCCM 80190 is considered hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l‐Lysine HCl produced by C. casei KCCM 80190 is considered 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) and l‐lysine HCl are considered 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.

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 renewal of the authorisation of Bacillus subtilis PB6, the extension of use to ornamental, sporting and game birds and a modification on the concentration of the said additive. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis. During the course of the current assessment, the active agent has been redesignated as Bacillus velezensis ATCC PTA‐6737. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent is established and the compliance with the other qualifications confirmed. Therefore, B. velezensis ATCC PTA‐6737 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. The additive is not a dermal/eye irritant or a skin sensitiser. Exposure via inhalation is unlikely. In the previous assessments performed by the FEEDAP Panel, the additive showed to be efficacious as a zootechnical additive in feedingstuffs for chickens for fattening and chickens reared for laying at the level of 1 × 107 CFU/kg. Considering that efficacy at the same level has been shown, this conclusion is extrapolated to ornamental, sporting and gaming birds.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Correlink™ ABS1781 Bacillus subtilis (hereafter designated as Correlink™ ABS1781) when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and minor growing poultry species. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis, which in the course of the current assessment, was reclassified as Bacillus velezensisNRRL B‐67259. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensisNRRL B‐67259 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Correlink™ ABS1781 is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. Correlink™ ABS1781 is not irritant to skin and eyes or a skin sensitiser but is a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of Correlink™ ABS1781 for the target species due to lack of data.

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 Correlink™ ABS747 Bacillus subtilis (hereafter designated as Correlink™ ABS747) when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and minor growing poultry species. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis, which in the course of the current assessment, was reclassified as Bacillus velezensis NRRL B‐67257. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NRRL B‐67257 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Correlink™ ABS747 is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. Correlink™ ABS747 is not irritant to skin and eyes or a skin sensitiser but is a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of Correlink™ ABS747 for the target species due to lack of data.

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 Actisaf® Sc 47 (Saccharomyces cerevisiae CNCM I‐4407) as a zootechnical additive for calves for rearing. The applicant has provided evidence that the additive currently in 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 calves for rearing, consumers and the environment under the authorised conditions of use. The additive is not a skin or eye irritant. In the absence of data, no conclusions can be drawn on the dermal sensitisation potential of the additive. Inhalation exposure is unlikely. 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.

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 Axtra® XAP 104 TPT as a zootechnical feed additive (digestibility enhancers) for poultry species. The additive contains three enzyme activities (endo‐1,4‐beta‐xylanase, protease and alpha‐amylase) produced by three different genetically modified strains. Viable cells and recombinant DNA of the strains producing the protease and amylase were not detected in the final product. Owing to the insufficient data, uncertainty remained on the presence in the additive of viable cells of the strain producing the xylanase. The results obtained in the genotoxicity and subchronic oral toxicity studies performed with the three fermentation products did not indicate safety concerns resulting from the fermentation products used in the formulation/manufacturing. However, uncertainties remain on the suitability of the test item used in the studies conducted with the xylanase; therefore, the Panel was not in the position to conclude on the toxicological potential of AXTRA ® XAP 104 TPT. Consequently, the Panel could not conclude on the safety of the additive for the target species, consumers and users. Owing to the uncertainty on the presence of viable cells of one of the production strains in the additive, the Panel could not conclude on the safety for the environment. The FEEDAP Panel concluded that AXTRA ® XAP 104 TPT 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 U xylanase, 200 U amylase and 4,000 U protease per kg feed. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens.

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 produced by fermentation with the genetically modified strain of Corynebacterium glutamicum DSM 32932. Neither the production strain nor its recombinant DNA were detected in the final product. The additive does not pose any safety concern associated with the genetic modification of the production strain. l‐Lysine HCl produced by C. glutamicum DSM 32932 is considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum DSM 32932 is not toxic by inhalation; it is not irritant to skin and not a skin sensitiser. The additive is not corrosive to eyes but it should be considered as an eye irritant. In general, l‐lysine HCl is considered as 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.

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 Lactobacillus buchneri DSM 29026 when used as a technological additive to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 108 colony‐forming units (CFU)/kg forage if used alone, or 5 × 107 CFU/kg forage if used in combination with other authorised microorganisms. The bacterial species L. buchneri is considered by the EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The FEEDAP Panel concluded that Lactobacillus buchneri DSM 29026 at a minimum concentration of 5 × 107 CFU/kg may improve the production of silage from easy and moderately difficult to ensile forage material.

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 CGMCC 7.266 when used as a 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 salts). None of those forms pose any safety concern associated with the genetic modification of the production strain. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 7.266 are considered safe for the target species, for the consumer and for the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via feed and water for drinking, simultaneously. In the absence of data, the FEEDAP Panel cannot conclude on the safety of both forms 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.

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 OptiPhos PLUS ® to be used as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening, minor poultry species reared for laying, minor poultry species reared for breeding and ornamental birds. The active substance is 6‐phytase produced by a genetically modified strain of Komagataella phaffii. The FEEDAP Panel concludes that the genetic modification of the production strain does not give rise to safety concerns. Based on the tolerance studies provided, the Panel concludes that the additive is safe for the target species under the conditions of use with a wide margin of safety. The additive is not a skin irritant. It is found to be a dermal sensitiser. The FEEDAP Panel cannot conclude on the eye irritation potential of the additive. Owing to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The FEEDAP Panel concludes that the additive has the potential to be efficacious in increasing the phosphorus utilisation in chickens for fattening at the level of 250 FTU/kg feed. These conclusions can be extended to turkeys for fattening and chickens and turkeys reared for laying/breeding and extrapolated to all minor poultry species and other avian species up to the point of lay.

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 Biacton® when used as a feed additive for chickens for fattening, turkeys for fattening and laying hens. Biacton® is a preparation of viable cells of Lactobacillus farciminis CNCM I‐3740 intended for use in feed for chickens for fattening, turkeys for fattening and laying hens at a minimum recommended application level of 5 × 108 CFU/kg complete feedingstuffs. L. farciminis is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment, and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In the absence of data, no conclusions can be drawn on the irritancy of Biacton® to skin and eyes or on its dermal sensitisation potential. The additive should be considered a respiratory sensitiser. Due to poor reporting and significant limitations in the data available, the FEEDAP Panel cannot conclude on the efficacy of the additive for chickens for fattening, turkeys for fattening and laying hens.

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 monosodium l‐glutamate monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80188 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. 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. Monosodium l‐glutamate monohydrate produced using C. glutamicum KCCM 80188 is considered safe for the target species, for the consumer and for the environment. Monosodium l‐glutamate monohydrated produced by C. glutamicum KCCM 80188 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. The FEEDAP Panel expressed reservations on the use of the additive in water for drinking due to concerns on its impact on the hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Lactobacillus parafarraginis DSM 32962 when used as a technological additive intended to improve the production of silage at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The bacterial species L. parafarraginis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive is not an eye or dermal irritant but should be considered a potential respiratory sensitiser. No conclusions can be drawn on the skin sensitisation potential of the additive. Three studies with laboratory‐scale silos were made using samples of easy and moderately difficult to ensile forage. In each case, replicate silos containing untreated forage were compared with identical silos containing the same forage to which Lactobacillus parafarraginis DSM 32962 was added to reach an intended concentration of 1 × 108 CFU/kg fresh matter. The results showed that the addition of the additive improves significantly the aerobic stability of the silage tested.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus casei when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 108 CFU (when used alone) or 5 × 107 CFU (when used in combination) kg/fresh matter. The species L. casei is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than the absence of resistance to antibiotics of human and veterinary significance. As the identity of the strain was clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed treated silage and the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy of the additive. The additive should be considered to have the potential to be a respiratory sensitiser. Five studies with laboratory‐scale silos were made using forage of differing water‐soluble carbohydrate content. Replicate silos containing forages treated at the proposed application rate were compared to identical silos containing the same but untreated forage. The mini‐silos were stored for 90 days at 20–24°C. At the end of the ensiling period, the content of the silos was analysed and dry matter losses determined. Results showed that the L. casei strain applied at a minimum dose of 5 × 107 CFU/kg has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing dry matter loss and enhancing protein preservation.

The additive OPTIPHOS ® is a preparation of 6‐phytase that is authorised for use in avian species, weaned piglets, pigs for fattening and sows. The applicant seeks for an extension of use of the product to finfish, at a dose range between 250 and 1,000 OTU/kg feed. The FEEDAP Panel concluded in a previous opinion that there are no concerns for consumer safety and no risks for the environment are expected from the use of the product as feed additive. Moreover, it was concluded that the additive is not a skin/eye irritant or a skin sensitiser, but has the potential to be a respiratory sensitiser. The Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. The results of a tolerance study performed in juvenile rainbow trout (Oncorhynchus mykiss) showed no negative effects of the additive on the fish when offered up to 100 times the maximum recommended dose. Therefore, the Panel concluded that the additive is safe for the rainbow trout and extrapolated this conclusion to all finfish. The Panel evaluated three efficacy trials, two performed in rainbow trout and one in Atlantic salmon (Salmo salar). In these studies, the performance of the fish was monitored as well as phosphorus digestibility and phosphorus retention parameters. In the three trials, the performance and the phosphorus retention were improved by the additive at the lowest tested dose (in rainbow trouts at 250 OTU/kg feed and in Atlantic salmon at 500 OTU/kg feed). The FEEDAP Panel concluded that the additive has a potential to be efficacious in rainbow trout and salmon at 500 OTU/kg. The Panel extrapolated the conclusion to all finfish species.

AviMatrix® (benzoic acid, calcium formate and fumaric acid) is intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed of chickens for fattening, chickens reared for laying, minor avian species for fattening and minor avian species reared to point of lay to increase performance. The additive has not been authorised in the EU. In 2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion in which, owing to insufficient tolerance data and the limited and inconsistent evidence of efficacy, a definitive conclusion on the safety and efficacy of the additive as a zootechnical additive could not be drawn. Additional data have been provided by the applicant related to the safety and the efficacy of the additive for the target species, which is the subject of this opinion. The FEEDAP Panel considers that the additive is tolerated by chickens for fattening up to the maximum recommended dose (1,000 mg/kg complete feed); this conclusion can be extended to chickens reared for laying. However, since no conclusion could be drawn on the margin of safety, the safety of the additive to minor avian species for fattening and to point of lay cannot be extrapolated. Data from three trials provided evidence that AviMatrix® at 500 mg/kg complete feed had the potential to improve the performance of chickens for fattening. The dose proposed for use with chickens reared for laying and minor poultry species for fattening and to point of lay is the same as that demonstrated being efficacious in a physiologically similar major species (chickens for fattening) and it can be reasonably assumed that the mode of action is the same. Consequently, the conclusion on efficacy for chickens for fattening can be extended to chickens reared for laying and extrapolated to minor poultry species for fattening and to point of lay.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strain to be established and evidence that it is not toxigenic and does not show acquired resistance to relevant antibiotics. In a previous opinion, the strain was found to meet the criteria for the QPS approach. Since no concerns are expected from other components of the additive, B‐Act® is presumed safe for the target species, consumers and the environment. In the same opinion, no conclusions could be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B‐Act® was considered a potential respiratory sensitiser. Since the use of B‐Act® with the target species is considered unlikely to introduce hazards for users of the product not already considered, the conclusions previously reached apply to the current application. B‐Act® at the recommended dose of 1.6 × 109 colony forming units (CFU)/kg feed has the potential to be efficacious in turkeys for fattening. Since the same dose is proposed for the minor poultry species for fattening or raised for laying, the conclusions can be extended/extrapolated to these species. The conclusions on the compatibility of B‐Act® with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal/lower than those for chickens.

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 modification of the terms of authorisation of lecithins as a feed additive for all animal species. Lecithins are currently authorised for use in feed for all animal species (Commission Implementing Regulation (EU) 2017/2325). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion of the additive lecithins in 2016. The Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as emulsifier. The requested modification refers to the alignment of the specifications of the feed additive to the specifications set for lecithins when used as food additives, and the inclusion in the authorisation of rapeseed among the botanical sources of hydrolysed and de‐oiled lecithins and of de‐oiled hydrolysed soybean lecithins as an additional form of the additive. Based on the data available, all the lecithins of different botanical origin and their forms under application meet the specifications set for the use of lecithins as a food additive. The Panel therefore recommended applying the specifications set for food additive to the lecithins under application. In its previous opinion, the Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as an emulsifier. The Panel is not aware of any information related to the use of rapeseed as an additional source of hydrolysed liquid lecithins and de‐oiled lecithin powder that would modify the previous conclusions.

ECONASE® XT is an enzyme preparation with endo‐1,4‐β‐xylanase which is authorised as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. The authorisation of the additive for pigs for fattening is at 24,000 BXU/kg feed. The applicant asked for a modification on the conditions of use in pigs for fattening, which consists in the reduction of the minimum recommended level from 24,000 BXU/kg feed to 16,000 BXU/kg feed. In previous opinions, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the safety of the product when used as a feed additive and concluded that the use of the product raises no concerns for consumer safety and no risks for the environment are expected. The Panel also concluded that the additive is non‐irritant to the skin, and the liquid form is non‐irritant to the eyes and is not a dermal sensitiser; however, it is considered a respiratory sensitiser. Regarding the use of the additive in pigs for fattening, the Panel concluded that under the conditions of use, the additive is safe for pigs for fattening and that it can be efficacious at 24,000 BXU/kg. In the current application, the applicant provided three efficacy trials to support the efficacy at 16,000 BXU/kg feed. Two of these studies had been previously evaluated by the FEEDAP Panel and supported the efficacy at 16,000 BXU/kg feed. The third study revealed a significant effect of the additive on the feed to gain ratio in pigs for fattening at 20,000 BXU/kg feed (analysed content). The FEEDAP Panel concluded that the additive has a potential to be efficacious in pigs for fattening as a zootechnical additive at the dose of 20,000 BXU/kg feed.

The additive is a natural mixture of talc and chlorite (NTMC) that contains at least 75% of talc and chlorite as main components. The additive is intended for use as a technological additive (functional groups: (i) anticaking agents) in premixtures and feedingstuffs for all animal species at use levels of 1,000–50,000 mg/kg. No safe dietary level of NMTC could be identified for piglets, chickens for fattening and dairy cows. The use of NMTC in animal nutrition is considered not to pose a risk for the consumer of animal tissues and products from animals fed the additive. Talc could cause serious lung disease if repeatedly inhaled in large quantities over a long period. Talc is not irritant to skin and eyes. In the absence of data, no conclusion can be drawn on the skin sensitisation potential of the product. The components of the additive (talc, chlorite, dolomite and magnesite) are ubiquitous in the environment, being natural components of soil. Therefore, it is not expected that its use as a feed additive would adversely affect the environment. The additive NMTC is efficacious as an anticaking agent.

Amylofeed® is a preparation of endo‐1,3(4)‐β‐glucanase, endo‐1,4‐β‐xylanase and α‐amylase aimed to be used as a feed additive for piglets and young minor porcine species. In a previous assessment, the safety of the additive for the target species, user and environment were established. However, the safety for the consumer and the efficacy of the product could not be established. In that previous assessment, the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided did not allow the Panel to conclude on the safety for the consumer. The applicant has now provided new data/information to assess the safety for the consumer and also new studies in order to support the efficacy of the additive in the target species. The enzymes present in the product are obtained from two different strains and from two different fermentation processes. In the current assessment, the applicant provided complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products. New genotoxicity studies were submitted by the applicant and the results showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study performed and previously submitted were valid for the current assessment; the results showed no evidence for adverse effects. Consequently, the Panel concluded that the additive is safe for the consumers when used as a feed additive. For the evaluation of the efficacy of the additive, the Panel considered four long‐term trials done in weaned piglets. Based on these data, the Panel concluded that the additive has a potential to be efficacious in weaned piglets at the nominal dose of 500 mg/kg feed and extrapolated this conclusion to growing minor porcine species.

l‐Arginine is considered to be a non‐essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l‐arginine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (KCCM 10741P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations at or below thresholds specified by EFSA; thus, C. glutamicum KCCM 10741P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded 99.8%, and no impurities of concern were detected. The use of l‐arginine produced by C. glutamicum KCCM 10741P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. l‐Arginine produced by C. glutamicum KCCM 10741P is considered corrosive to skin and eyes and therefore poses a risk by inhalation. The additive is an effective source of arginine for all species. For the supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against microbial degradation in the rumen.

The feed additive Aviax 5%, containing the active substance semduramicin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 20−25 mg/kg complete feed. Semduramicin sodium is present in Aviax 5% in its mycelial form and is produced by fermentation of Actinomadura spp. (ATCC 53664). Semduramicin sodium is active against certain Gram‐positive bacteria, while Gram‐negative bacteria are resistant; its use as a feed additive is unlikely to increase shedding of Salmonella, Escherichia coli and Campylobacter and to induce resistance and cross‐resistance to antimicrobials used of human and animal relevance. In the absence of a tolerance study in chickens for fattening performed according to the current EU standards, the FEEDAP Panel cannot conclude on the safety of Aviax 5%, containing semduramicin mycelium. Semduramicin sodium in the feed is not compatible with the concurrent use of tiamulin. Mycelial semduramicin sodium is not genotoxic. There is no evidence that the mycelial semduramicin is more toxic than the crystalline by oral administration. The acceptable daily intake (ADI) of 0.00125 mg/kg set for the crystalline semduramicin is applicable to mycelial semduramicin. The use of semduramicin sodium is safe for the consumer provided a withdrawal time of 24 h is respected. No conclusions can be made on the irritancy of Aviax 5% to skin and eye and on the potential for dermal and respiratory sensitisation. Model calculations on inhalation exposure of persons handling the additive indicate a serious risk. Aviax 5% used in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for the terrestrial compartment. A risk for the aquatic compartment and for groundwater pollution cannot be excluded. Aviax 5% at a minimum dose of 20 mg/kg feed has the potential to effectively control coccidiosis in chickens for fattening.

Natuphos® E is a feed additive that contains a 6‐phytase available in powder, granulated and liquid forms which is intended to be used as a feed additive for avian and porcine species. The production strain of the phytase present in the product is a genetically modified strain of Aspergillus niger. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the genetic modification of the production strain does not give rise to safety concerns. The production strain and its DNA were not detected in the concentrate used to formulate the products. Based on the tolerance studies provided, the Panel concluded that the additive is safe for the target species under the conditions of use with a wide margin of safety. The Panel also concluded that the use of the product as a feed additive does not give rise to concerns for consumers. Evidence was provided showing that the additive is not toxic by inhalation or irritant for skin or eyes, however, it should be regarded as a dermal sensitiser and a potential respiratory sensitiser. The use of the additive as a feed additive poses no risks to the environment. Based on the efficacy studies provided, the Panel concluded that the additive has the potential to be efficacious in chickens for fattening, turkeys for fattening, piglets, pigs for fattening and sows. These conclusions were extended to chickens reared for laying, turkeys reared for breeding and extrapolated to minor poultry species and other avian species for fattening and to the point of lay and to minor porcine species. The Panel considered that there was insufficient information to conclude on the efficacy in laying hens.

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 Probion Forte® when used in feed for chickens for fattening. Probion Forte® is a preparation containing viable spores of a strain of Bacillus subtilis and Bacillus coagulans intended for use in feed for chickens for fattening at the minimum dose of 1 × 108 and a maximum of 2 × 108 colony‐forming units (CFU)/kg feedingstuffs. In the view of the FEEDAP Panel, the identity of the bacterial strains is established as B. subtilis and B. coagulans and their susceptibility to relevant antibiotics is demonstrated. However, both bacterial strains belong to species capable of producing toxins. The absence of a toxigenic potential has not been demonstrated and, therefore, these strains do not qualify for a qualified presumption of safety (QPS) approach to safety assessment and separate studies on target animals and consumer safety are required. The data provided did not allow concluding on the safety for chickens for fattening or the consumers. Probion Forte® is not a skin or eye irritant but should be considered a potential respiratory sensitiser. No conclusion can be drawn on the skin sensitisation potential of the additive. In the absence of evidence that the two active agents are not toxigenic, Probion Forte® is considered as a hazard for those handling the additive. Probion Forte® is considered safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of Probion Forte® for chickens for fattening from the data provided.