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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of four bacteriophages infecting Salmonella enterica ser. Gallinarum B/00111, intended for be as a zootechnical additive (functional group: other zootechnical additives) for all poultry species. Bafasal® is proposed for use in water for drinking and liquid complementary feed to guarantee a minimum daily dose of 2 × 106 PFU/bird, to reduce the Salmonella spp. contamination of poultry carcasses and load in the environment, and to improve the zootechnical performance of the treated animals. In previous opinions, the FEEDAP Panel concluded that Bafasal® is safe for the target species, consumers and the environment and is not a skin or eye irritant but should be considered a respiratory sensitiser. No conclusion could be drawn on its dermal sensitisation potential. The additive showed the potential to decrease the counts of two Salmonella Enteritidis strains in boots swabs and caecal digesta of chickens for fattening. However, the Panel was not in the position to conclude on the capacity of Bafasal® to improve the zootechnical performance of poultry, to reduce the contamination of other Salmonella enterica strains, serovars or other Salmonella spp. in chickens, or to reduce the Salmonella spp. contamination of poultry other than chickens. In the current application, the claim on zootechnical performance has been withdrawn. Bafasal® is not a skin or eye irritant but should be considered a potential skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. Based on the new data provided, the Panel concluded that Bafasal® has the potential to reduce the environmental contamination with S. Enteritidis when used in feed and water for all poultry species. No conclusions could be drawn on the effects of the additive on other Salmonella serotypes.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lactiplantibacillus plantarum NCIMB 41028 as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 109 colony forming units (CFU)/kg fresh plant material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established, and no antimicrobial resistance genes of concern were detected. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The additive is not a skin irritant, but the Panel cannot conclude on the eye irritation potential of the additive. The FEEDAP Panel concluded that the addition of L. plantarum NCIMB 41028 at a minimum level of 1 × 109 CFU/kg fresh plant material has the potential to improve the production of silage from fresh material.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lactiplantibacillus plantarum NCIMB 30148 as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 109 colony forming units (CFU)/kg fresh plant material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established, and no antimicrobial resistance genes of concern were detected. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The additive is not a skin irritant, but the Panel cannot conclude on the eye irritation potential of the additive. The FEEDAP Panel concluded that the addition of L. plantarum NCIMB 30148 at a minimum level of 1 × 109 CFU/kg fresh plant material has the potential to improve the production of silage from fresh material.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives (functional group: silage additives) consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively. The additives are intended for use with all types of fresh materials and for all animal species at a proposed minimum concentration of 1 × 107 colony‐forming units of E. faecium ATCC 53519/kg fresh material or 5 × 106 CFU of E. faecium ATCC 55593/kg fresh material. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy since the dry matter content of the ensiled materials at the end of the experiments was not corrected for volatiles, which led to unreliable estimation of the dry matter loss, and the lack of positive effects on any of the other parameters. The supplementary information submitted by the applicant included updated data on the dry matter loss corrected for volatiles. The results showed that, at the end of the ensiling process, the dry matter loss during the ensiling was significantly lower in the ensiled materials treated with E. faecium ATCC 53519 or ATCC 55593 compared to controls. The FEEDAP Panel concludes that the addition of E. faecium ATCC 53519 or ATCC 55593 in all types of fresh plant materials shows potential to improve the nutrient preservation of silage at the proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ponceau 4R as sensory additives (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). The additive is already authorised for use with cats and dogs and ornamental fish. The additive is intended to be incorporated in freshwater fishing baits up to a maximum of 15 mg/kg in complementary feed in order to colour them. The additive is intended to be incorporated into feed directly in solid form or via an aqueous solution. The additive is not intended for use in aquaculture. The FEEDAP Panel concluded that ponceau 4R is considered safe when used in fish baits for freshwater fish at the maximum proposed dose of 15 mg/kg complementary feed. The use of the feed additive ponceau 4R fish baits for freshwater fish under the conditions of use proposed is of no concern for consumer safety. Ponceau 4R is not skin irritant but should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. In absence of data no conclusion can be reached on the efficacy of ponceau 4R in freshwater fish baits.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of Saccharomyces cerevisiae CNCM I‐1077 as a zootechnical feed additive for several animal species. The additive, existing in a not‐coated and a coated form, is currently authorised for use in feed for calves, cattle for fattening, dairy cows, dairy goats and dairy sheep, lambs, all minor ruminant species for fattening and rearing, horses and camelids for fattening and rearing. This application regards the request for the extension of use in all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses, and the modification of the authorisation for lambs to reduce the minimum use level. The identity of the active agent as S. cerevisiae was confirmed. Based on the qualified presumption of safety approach and since no concerns are expected from other components, the additive is considered safe for the target species, consumers and the environment. The not‐coated form of the additive is not irritant to skin or eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. No conclusion could be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive has the potential to be efficacious when used in feed for all ruminants and camelids reared for milk production/suckling/reproduction at the minimum proposed use level of 5 × 108 CFU (colony forming unit)/kg complete feed, all minor (young) ruminant species and camelids for fattening and lambs at 1 × 109 CFU/kg complete feed, and in all Equidae species other than horses at 3 × 109 CFU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on a formulation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with fresh plant material with a dry matter (DM) range of 32%–65% at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material to be used for all animal species. The bacterial species B. subtilis and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strains was established, no acquired antimicrobial resistance genes of concern were detected in any of the two active agents and no evidence of toxigenic potential was found in B. subtilis DSM 33862. Therefore, the FEEDAP Panel concluded that the use of the strains as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive contains microorganisms and therefore should be considered as a potential skin and respiratory sensitiser. The additive is not irritant to skin or eyes. Inhalation and dermal exposure is considered a risk. These conclusions would apply, in principle, to any preparations containing the active agents. The FEEDAP Panel concluded that the additive containing B. subtilis DSM 33862 and L. buchneri DSM 12856 at a minimum concentration of 1 × 108 CFU/kg fresh material has the potential to extend the aerobic stability of silage prepared from fresh plant materials with a DM range of 32%–65%.

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

Abstract Ammonium propionate is authorised as a liquid preparation of ≥ 19% ammonium propionate, ≤ 80% propionic acid and ≤ 30% water. The applicant requested for the renewal of the authorisation of ammonium propionate when used as a feed additive for all terrestrial animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of ammonium propionate under the current authorised conditions of use is safe for the target species, the consumers and the environment. Concerning the user safety, the additive is corrosive to skin and eyes. Any exposure is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the flowering tops of Thymbra capitata (L.) Cav. (Spanish type origanum oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for poultry species, 30 mg/kg for pigs and horses, 20 mg/kg for ruminants, 25 mg/kg for rabbits, dogs, cats and ornamental fish, and 125 mg/kg for salmonids. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 15 mg/kg complete feed. The FEEDAP Panel considered that the use level in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of the additive in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since T. capitata and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lentilactobacillus buchneri DSM 32651 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. buchneri is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The additive is not an eye irritant. The FEEDAP Panel concluded that the additive consisting of L. buchneri DSM 32651 at a minimum concentration of 1 × 108 CFU/kg fresh material may extend the aerobic stability of silage prepared from fresh plant material with a DM range of 28%–45%.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tea tree oil obtained from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long‐living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.5 mg/kg for turkeys for fattening, 1.7 mg/kg for laying hens, 2.0 mg/kg for piglets, 2.4 mg/kg for pigs for fattening, 3.1 mg/kg for sows, 5.0 mg/kg for veal calves (milk replacer) and salmonids, 4.4 mg/kg for cattle for fattening, sheep/goats and horses, 2.9 mg/kg for dairy cows, 1.8 mg/kg for rabbits, 0.9 mg/kg for cats, 5.3 mg/kg for dogs, 6.6 for crustaceans and 15 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to be of safety concern at 1.1 mg/kg complete feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. Regarding user safety, tea tree oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. It is classified as a reprotoxic substance (category 1B) following CLP criteria and should be handled accordingly. Since M. alternifolia and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product containing endo‐1,4‐β‐xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of Trichoderma reesei (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products. The Panel also concluded that ECONASE® XT is safe for pigs for fattening, laying hens and minor poultry species at the proposed conditions of use. The use of the additive raises no safety concerns for the consumers of products derived from animals fed with the additive or for the environment. The liquid and solid forms of ECONASE® XT are non‐irritant to the skin, but only the liquid forms were confirmed as non‐irritant to the eyes and not dermal sensitisers. The Panel could not conclude on the irritation potential to the eyes and the dermal sensitisation potential for the solid forms. Due to the proteinaceous nature of the active substance, the additive is considered to be a respiratory sensitiser. The additive has the potential to be efficacious in pigs for fattening at 20,000 BXU/kg complete feed, in all laying poultry species at 12,000 BXU/kg complete feed and in minor poultry species other than laying birds at 8000 BXU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tartrazine as sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). Tartrazine is intended to be incorporated in fishing baits up to a maximum of 30 mg/kg in complementary feed in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture. Tartrazine is already authorised for use with cats and dogs, ornamental fish, grain‐eating ornamental birds and small rodents. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of tartrazine in the preparation of baits for freshwater fish under the proposed conditions of use is of no concern for the target animals. The use of tartrazine as a feed additive under the proposed conditions of use is considered safe for the consumer and the environment. Regarding the user safety, the additive should be considered a dermal and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the irritation potential of the additive. In absence of data, no conclusion can be reached on the efficacy of tartrazine in freshwater fish baits.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae NCYC R618 as a zootechnical feed additive (functional group: gut flora stabiliser) for chickens for fattening and other poultry species for fattening and reared for laying. The additive has never been authorised. The strain under assessment S. cerevisiae (NCYC R618) qualifies for the qualified presumption of safety (QPS) and, consequently, the FEEDAP Panel concluded that the product is safe for the target species, the consumers and the environment. The FEEDAP Panel could not conclude on the skin and eye irritation or skin sensitisation potential of the additive. The additive should be considered a respiratory sensitiser. Due to the lack of sufficient data, the Panel cannot conclude on the efficacy of the additive under the proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of a preparation containing a smoke flavouring extract for cats and dogs. The applicant provided data demonstrating that the additive currently on the market does not fully comply with the conditions of authorisation, but with newly proposed specifications based on different analytical methods. Considering that the additive under assessment contains benzofuran and styrene, for which a potential concern for genotoxicity has been identified, and that the whole mixture raises a potential concern for genotoxicity, additional data would be needed to complete the assessment. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for cats and dogs. The additive is authorised for use in feed for cats and dogs, and therefore, there is no need to perform an assessment of the safety for the consumer and the environment. Regarding user safety, the additive 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 potential genotoxic substances may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lutein‐rich extract of Tagetes erecta L. as sensory additive (functional group: Colourants (ii) substances which, when fed to animals, add colours to food of animal origin) for turkeys for fattening. The additive is already authorised for use in feed for chickens for fattening and minor poultry for fattening and laying hens and minor poultry for laying. The FEEDAP Panel concluded that the use of lutein‐rich extract of T. erecta is safe for turkeys for fattening when used up to the maximum proposed use level of 80 mg total carotenoids/kg complete feed. The Panel concluded that the use of lutein‐rich extract of T. erecta in feed for turkeys for fattening under the proposed conditions of use would not be of concern for the consumer, considering also its use in other poultry for fattening and for laying hens. Regarding user safety, the lutein‐rich extract of T. erecta extract is irritant to skin and eyes and any exposure is considered a risk. The conclusions on user safety reached for the lutein‐rich extract of T. erecta would, in principle, apply to preparations made with it. The use of the additive in feed for turkeys for fattening under the proposed conditions of use is safe for the environment. The FEEDAP Panel concluded that the additive has the potential to colour the skin of turkeys for fattening at the proposed conditions of use.

Abstract Propionic acid is currently authorised as a technological additive (functional group: silage additives) for all animal species. The applicants requested for the renewal of the authorisation of propionic acid when used as a feed additive for all terrestrial animal species. The applicants have provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of propionic acid under the current authorised conditions of use is safe for the target species, the consumers and the environment. Regarding user safety, the additive is corrosive to the skin and any exposure to users is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of diclazuril (Clinacox® 0.5%) as a coccidiostat for chickens for fattening and chickens reared for laying. The additive currently on the market complies with the existing conditions of authorisation. The additive remains safe for the target species and the consumer under the authorised conditions of use. The additive is irritant to skin, eyes and respiratory tract but is not a skin sensitiser. Exposure by inhalation cannot be excluded. The FEEDAP Panel cannot conclude on the safety for the environment of diclazuril from Clinacox® 0.5% due to lack of data. Diclazuril from Clinacox® 0.5% at a concentration of 1 mg diclazuril/kg complete feed has the potential to control coccidiosis in chickens for fattening. This conclusion is extended to chickens reared for laying. Development of resistance to diclazuril of field Eimeria spp. strains isolated from chickens should be monitored.

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

Abstract Sodium propionate is authorised containing at least 98.5% of sodium propionate. The applicants requested for the renewal of the authorisation of sodium propionate when used as a feed additive for all terrestrial animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of sodium propionate under the current authorised conditions of use is safe for the target species, the consumers and the environment. Considering the user safety, the additive is corrosive to skin, eyes and respiratory tract, but is not a skin sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha‐amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non‐irritant to the skin and the solid form was shown to be non‐irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species.

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

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

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

Abstract This guidance document is intended to assist the applicant in preparing and presenting an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the efficacy of feed additives.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae CNCM I‐1079 as a zootechnical feed additive for dogs and all other Canidae. The additive is intended for use in feed for dogs and all other Canidae at a proposed minimum inclusion level of 1 × 109 CFU per kg of complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and no concerns are expected from other components of the product, the additive is considered safe for the target species. Since the additive is intended to be used only in feed for dogs and other non‐food‐producing animals, an assessment of the safety for the consumer and the environment is not needed. The non‐coated form of the additive was shown to be non‐irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both forms, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Panel was not in the position to conclude on the efficacy of Saccharomyces cerevisiae CNCM I‐1079 at the proposed conditions of use.

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of a preparation of dried cells of Saccharomyces cerevisiae CNCM I‐4407 (Actisaf® Sc 47) as a zootechnical additive for rabbits for fattening and non‐food producing rabbits. The applicant provided evidence that the additive currently in the market complies with the existing terms of the authorisation. The Panel concluded that the additive remains safe for the target species, consumers and the environment. Regarding the safety for the user, the additive is not a skin or eye irritant. However, it should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tinctures obtained from the dried leaves of Ginkgo biloba L. (ginkgo tinctures) when used as sensory additives. The tinctures are water/ethanol solutions with a dry matter content of 5.7% (tincture A) and 3.0% (tincture B). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additives under assessment are safe for the target species at the following concentrations in complete feed: (i) ginkgo tincture A at 240 mg/kg for horses and 750 mg/kg for dogs; (ii) ginkgo tincture B at 600 mg/kg for horses and 50 mg/kg for all other animal species. No safety concern would arise for the consumer from the use of ginkgo tinctures up to the maximum proposed use level in feed for the target species. The tinctures should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of ginkgo tinctures at the proposed use levels in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that ginkgo tinctures would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additives.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of citronella oil obtained from the leaves of Cymbopogon nardus (L.) Rendle, when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that citronella oil from C. nardus is of low concern for long‐living and reproductive animals at the use levels in complete feed of 3.5 mg/kg for laying hens and rabbits, 6 mg/kg for sows and dairy cows, 9.5 mg/kg for sheep/goats and horses, 2.0 mg/kg for cats and 10 mg/kg for dogs. For short‐living animals (species for fattening), the additive was considered of no concern at concentrations of 18 mg/kg in chickens for fattening, 24 mg/kg in turkeys for fattening, 20 mg/kg for piglets, pigs for fattening, veal calves (milk replacer), cattle for fattening, sheep/goats for meat production, horses for meat production and rabbits for meat production, and 30 mg/kg for salmonids. The conclusions were extrapolated to physiologically related minor species. For any other species, the additive is considered of low concern at 2.0 mg/kg complete feed. The use of citronella oil in animal feed is expected to be of no concern for the consumers and for the environment. The essential oil under assessment should be considered as irritant to skin and eyes and as a dermal sensitiser. When handling the essential oil, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of C. nardus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of ROVABIO® ADVANCE (liquid and solid) which contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 as a zootechnical feed additive for weaned piglets at the recommended use level of 1800 U xylanase and 1250 U glucanase per kg feed. In a previous assessment, three long‐term trials in weaned piglets were submitted. Two of them were considered to support the efficacy of the additive while a third trial was not further considered due to the large number of veterinary treatments applied. A new trial was provided to support the efficacy of the additive, but it did not show a significant improvement of the performance parameters at the minimum recommended use level. Due to the lack of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive for the target species.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat salinomycin sodium (Sacox®) for rabbits for fattening. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of salinomycin sodium (SAL‐Na) from Sacox® does not raise safety concerns for the target species, consumers, users and the environment with regard to the production strain. In the absence of adequate tolerance studies, the FEEDAP Panel could not conclude on the safety of SAL‐Na from Sacox® for rabbits for fattening. The FEEDAP Panel concluded that the additive is safe for the consumer when it is used at the proposed maximum level of 25 mg SAL‐Na/kg complete feed for rabbits and a withdrawal period of 1 day is respected. The following maximum residue limits (MRL) are proposed for the marker residue compound salinomycin (SAL): 0.2 and 0.03 mg SAL/kg for liver and kidney, respectively. The additive is not irritant to skin and eyes but should be considered a potential dermal and respiratory sensitiser. A risk for inhalation toxicity could not be excluded. The use of the SAL‐Na from Sacox® in feed for rabbits for fattening up to the highest proposed level will not pose a risk for the terrestrial and aquatic compartment and ground water. The risk of secondary poisoning can be excluded for worm‐eating birds and mammals, while it cannot be excluded for fish‐eating birds and mammals. The FEEDAP Panel concludes that SAL‐Na from Sacox® at the minimum concentration of 20 mg SAL‐Na/kg complete feed has the potential to control coccidiosis in rabbits for fattening. Development of resistance to SAL‐Na of field Eimeria spp. strains isolated from rabbits for fattening should be monitored.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of muramidase produced with Trichoderma reesei DSM 32338 (Balancius™) as a feed additive for laying hens. The additive is already authorised as a zootechnical additive (functional group: other zootechnical additives) for chickens, turkeys and minor poultry species for fattening or reared for breeding, and for weaned piglets. The enzyme is produced by fermentation with a genetically modified strain of Trichoderma reesei; viable cells of the production strain and its recombinant DNA were not detected in the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not give rise to safety concerns regarding the genetic modification of the production strain. Based on the data available from a sub‐chronic oral toxicity study, the Panel concluded that the additive is safe for laying hens at the maximum recommended level of 60,000 LSU(F) (muramidase activity units)/kg feed. The Panel also concluded that the additive is safe for the consumers and the environment. The liquid formulation of the additive is considered not irritant to the skin or eyes. The solid formulation of the additive is considered not irritant to the skin. The Panel cannot conclude on the potential of the additive (both formulations) to be a dermal sensitiser or on the potential of the solid formulation to be irritant to the eyes. Due to the proteinaceous nature, both forms of the additive should be considered respiratory sensitisers. The additive has the potential to be efficacious as a zootechnical additive for laying hens at 30,000 LSU(F)/kg feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 6‐phytase (Quantum® Blue) as a zootechnical feed additive for fin fish. The additive is authorised for use in poultry and pigs. The additive is available in solid and liquid forms, and the 6‐phytase contained in the product is produced by fermentation with a genetically modified strain of Trichoderma reesei. The 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; viable cells of the production strain and its DNA were not detected in the final products. The FEEDAP Panel concluded that, based on the data available, the additive tested is safe for fin fish at the highest recommended level of 2500 phytase activity unit (FTU)/kg complete feed. The Panel concluded that Quantum® Blue is not an irritant to skin and eyes nor a skin sensitiser. Owing to the proteinaceous nature of the active substance, 6‐phytase (Quantum® Blue) is considered a respiratory sensitiser. The use of Quantum® Blue as a feed additive is considered safe for the environment. The additive is considered to be efficacious as a zootechnical additive for salmonids and ornamental fish at 500 FTU/kg complete feed and other fin fish at 2500 FTU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) as a zootechnical feed additive for suckling and weaned piglets and other growing Suidae. The additive is standardised to contain a concentration of the sum of the four alkaloids sanguinarine, chelerythrine, protopine and allocryptopine of 1.25%, with 0.5% sanguinarine. Owing to the presence of the DNA intercalators sanguinarine and chelerythrine, a concern for genotoxicity was identified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concerns for the target species when the additive is used at the recommended level of 0.750 mg sanguinarine/kg complete feed for suckling and weaned piglets and other growing Suidae. Since in all consumer categories the exposure to sanguinarine and chelerythrine via the use of Sangrovit® Extra exceeds the threshold of toxicological concern of 0.0025 μg/kg bw per day for DNA reactive mutagens and/or carcinogens, the FEEDAP Panel could not conclude on the safety for the consumers. The additive was shown to be irritant to the eyes but not irritant to skin or a skin sensitiser. The FEEDAP Panel could not exclude the potential of the additive to be a respiratory sensitiser. When handling the additive, exposure of unprotected users to sanguinarine and chelerythrine may occur. Therefore, to reduce the risk, the exposure of users should be reduced. The use of Sangrovit® Extra as a feed additive under the proposed conditions of use was considered safe for the environment. The additive Sangrovit® Extra had the potential to be efficacious in improving performance of weaned piglets at 0.600 mg sanguinarine/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of ferrous lysinate sulfate (Plexomin® L‐Fe) for all animal species. The additive has not been previously authorised as a feed additive in the European Union (EU). The safety of the additive for the target species, consumer, user and the environment has already been assessed in previous opinions. However, the efficacy remained inconclusive due to the absence of evidence of the bioavailability of the iron contained in the additive in the trials submitted either with chickens for fattening or with weaned piglets. For the present assessment, the applicant submitted a recalculation of the previous data on weaned piglets, which did not show evidence of bioavailability. Therefore, in the absence of adequate data, the FEEDAP Panel could not conclude on the efficacy of ferrous lysinate sulfate for all animal species.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DSM 34246 as a zootechnical feed additive for dogs and cats. The additive, with the trade name Canobios‐BL, is intended for use in feed for cats and dogs at a proposed minimum inclusion level of 5 × 109 CFU/kg complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and the additive is composed by dried cells of the active agent and an emulsifier, that are not expected to introduce any risk, the additive is considered safe for the target species. Canobios‐BL is not a skin or eye irritant but should be considered a skin and respiratory sensitiser. Canobios‐BL is considered to be efficacious in feedingstuffs for dogs and cats at the use level 5 × 109 CFU/kg complete feed.

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Saccharomyces cerevisiae CNCM I‐4407 (Actisaf® Sc47) as a zootechnical feed additive (functional group: gut flora stabiliser) in cattle for fattening. The additive is already authorised for use in feed for dairy cows, calves for rearing, lambs for fattening, dairy goats, dairy sheep and dairy buffaloes. In a previous opinion, the EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that Actisaf® Sc47 was safe for cattle for fattening, the consumers and the environment. Additionally, the Panel considered that Actisaf® Sc47 is not a skin irritant, and no conclusions could be drawn on the additive's eye irritancy and dermal sensitisation potential. Due to the lack of adequate data, the Panel could not conclude on the efficacy of the additive in cattle for fattening at the proposed conditions of use. In the current application, the applicant submitted three trials to support the efficacy in cattle for fattening. However, two of them were not considered for the assessment. The other trial showed an improved zootechnical performance of the animals at the proposed use level of 4 × 109 CFU/kg complete feed. Considering the additive is authorised in dairy cows and calves for rearing and the requirements of the current Guidance on the assessment of the efficacy of feed additives, no further demonstration of efficacy is necessary to extrapolate the conclusions previously reached to all ruminants. The significant positive effect shown in one trial in cattle for fattening supports the above extrapolation. Therefore, the FEEDAP Panel concludes that Actisaf® Sc47 is efficacious as a zootechnical additive for cattle for fattening at the proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Patent Blue V as a sensory feed additive for non‐food‐producing animals. The additive is already authorised for use with non‐food‐producing animals. The applicant has not provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel cannot conclude whether the additive remains safe for the target species due to the non‐compliance with the specifications and the lack of adequate data on the potential aneugenicity of the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a dermal and eye irritant nor a dermal and respiratory sensitiser. Since the potential genotoxicity of the additive was not ruled out, the exposure to the additive of the unprotected users should be minimised. The Panel retains that the previously made conclusion on the efficacy remains valid.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive obtained from the dried leaves of Ginkgo biloba L. (ginkgo extract) when used as a sensory additive in feed for horses, dogs, cats, rabbits and guinea pigs. Ginkgo extract contains ≥ 24% total flavonoids, ≥ 6% total terpene lactones and ≤ 1 mg/kg ginkgolic acids. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ginkgo extract is safe for the target species at the following concentrations in complete feed: 2.8 mg/kg for horses and cats, 1.1 mg/kg for rabbits and guinea pigs, and 3.3 mg/kg for dogs. No safety concern would arise for the consumers from the use of ginkgo extract up to the highest level in feed which is considered safe for food‐producing species (horses and rabbits). The additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the additive at the proposed level in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that the ginkgo extract would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additive.

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs. However, the Panel was not in the position to conclude on the efficacy of BioCell® for calves, and, consequently, for other ruminants for fattening or rearing. The applicant provided three additional efficacy trials in veal calves to support the efficacy of BioCell® for ruminants for fattening or rearing. The three studies showed positive effects of the supplementation with the additive at 1.7 × 109 colony forming unit (CFU)/kg complete feed on the performance of veal calves. Considering the previously submitted studies in dairy cows and the new submitted trials, the FEEDAP Panel concluded that the additive has the potential to be efficacious for all ruminants at the proposed condition of use: 4.0 × 108 CFU/kg complete feed for dairy ruminants and 4.0 × 109 CFU/kg complete feed for ruminants for fattening and rearing.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lanthanum carbonate octahydrate as a zootechnical feed additive for dogs. The additive is already authorised for use in feed for cats. The FEEDAP Panel concluded that the additive lanthanum carbonate octahydrate is safe for adult dogs at the maximum recommended level of 7500 mg/kg complete feed. The additive is not irritant to skin or eyes, is not a skin sensitiser and exposure by inhalation is considered to be unlikely. The Panel also concluded that lanthanum carbonate octahydrate is efficacious in the reduction of phosphorus bioavailability in adult dogs at the minimum inclusion level of 1500 mg/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B12 (cyanocobalamin) produced by fermentation with a non‐genetically modified strain of Ensifer adhaerens (CGMCC 21299), when used as a nutritional additive for all animal species. No viable cells or DNA of the production strain were detected in the additive. Therefore, cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 does not raise safety concerns as regards to the production strain. The Panel on Additives and Products or Substances used in Animal Feed concluded that cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 is considered safe for all animal species, for the consumers and the environment. Due to the presence of nickel, the additive is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. Due to the lack of data, the Panel could not conclude on the potential of the additive to be an eye irritant. Cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 is effective in meeting animal's nutritional requirements when administered via feed.