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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of endo‐1,4‐beta‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a zootechnical feed additive (functional group: digestibility enhancers) for all poultry. In a previous opinion, the FEEDAP Panel concluded that Xygest™ HT is safe for all poultry, consumers, and the environment. The additive is not considered to be irritant to eyes and skin but a dermal and a respiratory sensitiser, although exposure by inhalation is unlikely. The Panel also concluded that the additive has the potential to be efficacious in laying hens at 45,000 U/kg complete feed and this conclusion was extrapolated to all laying poultry. However, the Panel could not conclude on the efficacy of the product in growing poultry at the proposed conditions of use. In the current application, the applicant provided an additional efficacy trial in chickens for fattening. The results showed a higher apparent metabolisable energy (nitrogen corrected) in chickens fed the additive at the minimum proposed level of 30,000 U/kg complete feed when compared to the control group. Considering the previously submitted studies in laying hens and chickens for fattening, and the newly submitted study in chickens for fattening, the Panel concluded that Xygest™ HT has the potential to be efficacious to enhance digestibility in all poultry at the corresponding proposed minimum levels in feed.

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lentilactobacillus buchneri DSM 32650 as a technological feed additive (functional group: silage additive) for all animal species. The additive is 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. buchneri is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety (QPS) 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 the target species, consumers and 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 FEEDAP Panel concluded that Lentilactobacillus buchneri DSM 32650 at a minimum concentration of 1 × 108 CFU/kg fresh material may extend the aerobic stability of silage from easy and moderately difficult to ensile fresh material with a dry matter content ranging from 28% to 45%.

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 a product containing β‐mannanase produced by a non‐genetically modified strain of Aspergillus niger (CBS 120604). The commercial name is Nutrixtend Optim and it is intended to be used as a zootechnical feed additive for all poultry for fattening. Based on a tolerance trial in chickens for fattening and the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry for fattening. The Panel concluded that the use of the product as a feed additive does not give rise to concerns for consumers and the environment. The additive is considered an irritant to skin and eyes and a dermal sensitiser. Due to the proteinaceous nature of the active substance, it is also considered a respiratory sensitiser. The Panel concludes that the additive has the potential to be efficacious as a zootechnical additive at the level of inclusion in feed of chickens for fattening of 30 U β‐mannanase/kg complete feed. This conclusion was extrapolated to all poultry for fattening.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation consisting of essential oils of thyme and star anise, and quillaja bark powder (BIOSTRONG® 510 all natural) as a zootechnical feed additive (functional groups: digestibility enhancer; other zootechnical additives) for all poultry species. BIOSTRONG® 510 all natural is a preparation of partially microencapsulated essential oils, quillaja bark powder, dried herbs and dried spices. The additive contains estragole (up to ■■■■■. For short‐living animals, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concerns when the additive is used at the recommended level of 150 mg/kg complete feed for chickens for fattening and other poultry species for fattening. For long‐living animals, the use of the additive was considered of concern owing to the presence of estragole. No safety concern would be expected for the consumer and the environment from the use of the additive at the recommended use level in feed. The Panel concluded that the additive is corrosive to the eyes but not irritant to skin. It may be a respiratory irritant or dermal or respiratory sensitiser. When handling the additive, exposure of unprotected users to estragole ■■■■■ may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The additive BIOSTRONG® 510 all natural was considered efficacious for chickens for fattening at the use level 150 mg/kg complete feed. This conclusion was extrapolated to all poultry species for fattening or reared for laying/breeding. ■■■■■

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of BA‐KING® Bacillus velezensis as a zootechnical feed additive to be used as a gut flora stabiliser for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and all avian species for fattening or rearing to slaughter or point of lay including non‐food producing species. The product under assessment is based on viable spores of a strain identified as B. velezensis, which is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. In a previous opinion, the FEEDAP Panel concluded that BA‐KING® was safe for the target species, consumers of products derived from animals fed the additive and the environment. Additionally, the additive was not irritant to skin but potentially irritant to eyes and respiratory sensitiser. The Panel could not conclude on the efficacy of the additive for the target species at the proposed conditions of use. In the current application, two additional efficacy trials in chickens for fattening were provided. The results showed an improvement in the performance parameters of chickens when supplemented with BA‐KING® at 2.0 × 108 CFU/kg complete feed relative to a control group. Considering the previously submitted studies and the newly submitted studies in chickens for fattening, the Panel concluded that BA‐KING®, supplemented at 2.0 × 108 CFU/kg complete feed, has the potential to be efficacious in all avian species for fattening or reared for laying/breeding and non‐food‐producing avian species at the same physiological stage.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 4‐methyl‐5‐vinylthiazole [15.018] belonging to chemical group 29 (thiazoles, thiophene and thiazoline), when used as sensory additive (flavourings) in feed for all animal species. The FEEDAP Panel concluded that 4‐methyl‐5‐vinylthiazole [15.018] was safe at the maximum proposed use level of 0.5 mg/kg complete feed for veal calves (milk replacer), dogs, salmonids and ornamental fish. For the other species, the calculated safe concentrations in complete feed are: 0.4 mg/kg for cattle for fattening, sheep/goat, horses and cats; 0.3 mg/kg for sows and dairy cows; 0.2 mg/kg for piglets, pigs for fattening, rabbits and laying hens; and 0.1 mg/kg for chickens for fattening and turkeys for fattening. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 0.1 mg/kg complete feed. No safety concern would arise for the consumer from the use the additive up to the maximum proposed use level in feed. The additive should be considered as irritant to skin and eyes and the respiratory tract, and as dermal and respiratory sensitisers. The use of 4‐methyl‐5‐vinylthiazole [15.018] as a flavour in animal feed was not expected to pose a risk to the environment. Since the compound under assessment is used in food as flavouring and its function in feed is 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 assessment of the application for renewal of Pediococcus pentosaceus NCIMB 30168 as a technological additive for use in forage for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation, and skin and eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium ferrocyanide as a technological feed additive, functional group anticaking agents, for all animal species. The additive potassium ferrocyanide is intended to be used in potassium chloride with a maximum content of 150 mg ferrocyanide anion/kg salt. The use of potassium ferrocyanide is safe, when added to potassium chloride at a maximum content of 150 mg ferrocyanide anions (anhydrous)/kg for: pigs for fattening and lactating sows, sheep, goats, salmon and dogs. In the absence of a margin of safety, the use of potassium chloride according to the proposed conditions of use is not considered to be safe for chickens for fattening, laying hens, turkeys, piglets, veal calf, cattle for fattening, dairy cows, horse, rabbit and cats. In the absence of information on the use of potassium chloride in the diets for any other animal species, no conclusion on a potentially safe level of potassium chloride, supplemented with 150 mg ferrocyanide/kg, can be made. The use of potassium ferrocyanide in animal nutrition is of no concern for consumer safety. The results of in vivo studies showed that potassium ferrocyanide is not irritant to skin and eye and is not a skin sensitiser. However, due to the presence of nickel, the additive should be considered as a respiratory and dermal sensitiser. The available data do not allow the FEEDAP Panel to conclude on the safety of the additive for the soil and the marine environment, while the use of the additive in land‐based aquaculture according to the proposed conditions of use is considered of no concern. Potassium ferrocyanide is considered to be efficacious as an anticaking agent when included in potassium chloride at the proposed use levels.

Abstract Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat monensin sodium (Elancoban® G200) when used as a feed additive for chickens for fattening and turkeys. Based on the new data provided, the Panel updates its previous conclusions as follows: monensin sodium is produced by fermentation by a non‐genetically modified strain of Streptomyces sp. NRRL B‐67924. Genome analysis suggests the production strain may belong to a new species within the genus Streptomyces. The production strain and its DNA were not detected in the final additive. The product is free of antimicrobial activity other than monensin. The FEEDAP Panel cannot conclude on the safety of monensin sodium from Elancoban® G200 in feed for chickens for fattening and chickens reared for laying at the proposed maximum use level due to a dose‐related reduction of the final body weight. The toxicological profile of monensin sodium was evaluated in studies made with the product obtained from the parental strain ATCC 15413. Based on a comparison of the genomes of the two strains, the FEEDAP Panel concludes that toxicological equivalence has been established, thus the conclusions already drawn on Elancoban® G200 are valid for the product obtained with the new production strain concluding that the additive is safe for the consumer and the environment; the production strain does not represent an additional risk when safety for the user is considered. Monensin sodium from Elancoban® G200 is safe for turkeys up to 16 weeks of age at the concentration of 100 mg monensin sodium/kg feed and has the potential to control coccidiosis at the minimum concentration of 60 mg/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the environment of diclazuril (Coxiril®) as a coccidiostat feed additive for chickens reared for laying and pheasants. In its previous assessments, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not reach a final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril®. On the basis of the new data provided, the FEEDAP Panel updates the previous conclusions as follows: no risk is expected for the terrestrial compartment and for sediment when diclazuril is used in chickens reared for laying and to pheasants at the proposed condition of use (in both acidic and non‐acidic soils). No concern for groundwater is expected for both acidic and non‐acidic soils. Due to the lack of data, no conclusions can be drawn for the aquatic compartment. Diclazuril does not have the potential for bioaccumulation; therefore, a risk of secondary poisoning is unlikely.

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 obtained from the oleoresin of Pinus pinaster Aiton (pine white oil, also known as turpentine oil), when used as a sensory additive in feed and water for drinking for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the essential oil under assessment is safe up to the maximum proposed use levels of 35 mg/kg for laying hens, piglets, pigs for fattening, sows, rabbits, salmonids, 50 mg/kg for veal calves (milk replacer), cattle for fattening, dairy cows, horses, dogs and ornamental fish, 20 mg/kg for cats. For the other species, the calculated safe concentrations in complete feed were 25 mg/kg complete feed for chickens for fattening, 33 mg/kg for turkeys for fattening and 14 mg/kg for ornamental birds. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 20 mg/kg complete feed. No concerns for consumers were identified following the use of pine white oil up to the maximum proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of pine white oil at the proposed use level in feed was not expected to pose a risk for the environment. Pine white oil was recognised to flavour food. Since 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 Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. The product, manufactured in three formulations (microsphere, micropellet and powder), is intended for use in complete feed at a minimum inclusion level of 3 × 109 CFU/kg complete feed for horses, 4 × 108 CFU/kg complete feed for dairy cows and minor dairy species, 4 × 109 CFU/kg complete feed for calves, cattle for fattening, minor growing and fattening ruminants, piglets and pigs for fattening and minor porcine species and 6 × 109 CFU/kg complete feed for sows and minor porcine species for reproduction. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was conclusively established and, therefore, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive, in any formulation, is not irritant to the eyes and skin but should be considered a respiratory sensitiser. The Panel cannot conclude on the skin sensitisation potential of the additive. The Panel 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 the additive for calves, and neither for cattle for fattening, minor growing and fattening ruminants.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6‐phytase produced by the genetically modified strain Komagataella phaffii CGMCC 12056 (APSA PHYTAFEED® 20,000 GR/L) as a zootechnical feed additive (functional group: digestibility enhancers) for pigs for fattening at a minimum recommended level of 1,000 U /kg feed. In a previous assessment, three trials were submitted; one of them showed significant improvements on zootechnical parameters supporting the efficacy of the additive. The other two trials evaluating apparent faecal phosphorus digestibility and bone mineralisation, showed no improvements on phosphorus retention in bone and, therefore, the FEEDAP Panel could not conclude on the efficacy of the additive. The applicant submitted two new efficacy studies in pigs for fattening evaluating the animal's zootechnical performance, apparent faecal phosphorus digestibility and bone mineralisation. One of the trials was not considered due to high rates of mortality, culling of animals and medical treatments applied. In the other trial, significant improvements on final body weight and apparent total track phosphorus digestibility were found in the animals that received the phytase at 1,000 U/kg complete feed. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of the additive in pigs for fattening.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed for weaned piglets to improve their performance. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 viable‐forming units (VFU)/g additive. However, in that opinion, the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address the missing information for the characterisation of the additive. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. Sorbiflore® ADVANCE is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactiplantibacillus plantarum DSM 11520 when used as a technological additive (acidity regulator) in feed for horses, dogs, cats and pet rabbits. The additive is intended to be incorporated into oat‐derived products (ca. 55% moisture content), carrot root‐derived products (≥ 90% moisture) and coconut flesh‐derived products (≥ 90% moisture) at a minimum inclusion level of 8.0 × 1010 CFU/kg of the feed material under scope. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance. The FEEDAP Panel concluded that the use of this strain in animal nutrition is safe for the target species, consumers of horse meat and the environment. Regarding the user safety, the additive Lactiplantibacillus plantarum DSM 11520 is not irritant to skin or eyes in the product tested containing maltodextrin and oat bran as carriers, but owing to its proteinaceous nature, it should be considered a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation potential of the additive. The FEEDAP Panel concluded that incorporation of Lactiplantibacillus plantarum DSM 11520 at a minimum concentration of 8.0 × 1010 CFU/kg into oat‐derived products (ca. 55% moisture content), carrot root‐derived products (≥ 90% moisture) and coconut flesh‐derived products (≥ 90% moisture) has the potential to reduce the pH of these feedingstuffs.

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the feed additive containing endo‐1,4‐β‐glucanase produced by Trichoderma citrinoviride IMI 360748 (Hostazym® C). The product is authorised as a zootechnical additive (functional group: digestibility enhancers) for use in chickens for fattening, minor poultry species for fattening and weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation for the use in those species/categories, and the extension of use to chickens reared for laying, turkeys reared for breeding, minor poultry species reared for laying or breeding, ornamental birds and suckling piglets. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that the additive is safe for the target species, the consumers, and the environment under the authorised conditions of use. This conclusion also applies to the target species for which a request for an extension of use is made. The additive is considered not a skin corrosive or eye irritant, but it should be considered a skin sensitiser. The Panel cannot conclude on the potential of the additive to be a skin irritant. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel considers that the additive has the potential to be efficacious at 500 CU/kg complete feed in all poultry for fattening, reared for laying or breeding, and ornamental birds, and at 350 CU/kg complete feed in piglets (weaned and suckling, for the period in which solid feed is given).

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of anise oil and anise tincture obtained from the fruit of Pimpinella anisum L., when used as sensory additives. The use of the anise oil at the proposed use level in complete feed of 1.9 mg/kg for laying hens and 5 mg/kg for horses was considered of low concern. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concern when anise oil is used at the proposed use levels of 1.5 mg/kg for chickens for fattening and at 1.7 mg/kg for turkeys for fattening. The use of anise tincture at the proposed conditions of use was considered of low concern in dogs, cats, horses and laying hens, and of no concern in chickens for fattening. The use of the additives up to the highest level in feed which was considered of low or no concern for target animals was also expected to be of no concern for consumers. The additives under assessment should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. Due to the high concentration of estragole (≥ 1%), anise oil is classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. When handling anise tincture, exposure of unprotected users to estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of these additives in animal feed was not expected to pose a risk to the environment. Since the fruit of P. anisum and its preparations are recognised to flavour food and their function in feed would be the same, 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 feed additive consisting of a dry grape extract (Nor‐Grape® α) as a zootechnical feed additive, functional group physiological condition stabilisers ‐ increase antioxidant defences, for all avian species. The additive is already authorised for use as a feed flavouring for all animal species, except dogs. The FEEDAP Panel concluded that the additive is safe for all avian species. The use of the additive in animal nutrition is of no concern for consumer safety. Based on the data submitted, the FEEDAP Panel could not conclude on the potential of the additive to be a skin or eye irritant or a dermal or respiratory sensitiser. However, the Panel considered that exposure through inhalation is likely. The use of the feed additive is considered safe for the environment. The Panel was unable to conclude on the potential of the additive to be efficacious under the proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of juniper oil and juniper tincture obtained from the berries of Juniperus communis L., when used as sensory additives for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that juniper oil is safe up to the maximum proposed use levels in complete feed of 5 mg/kg for laying hens, 15 mg/kg for veal calves (milk replacer) and cattle for fattening and 20 mg/kg for ornamental fish. For the other species, the calculated safe concentrations in complete feed were 4 mg/kg for chickens for fattening, 5 mg/kg for turkeys for fattening, 7 mg/kg for piglets, 8 mg/kg for pigs for fattening, 10 mg/kg for sows, dairy cows, 16 mg/kg for sheep, goats and horses, 6 mg/kg for rabbits, 17 mg/kg for salmonids, 18 mg/kg for dogs and 3 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 3 mg/kg complete feed. The FEEDAP Panel concluded that juniper tincture is safe up to the maximum proposed use level in feed of 45 mg/kg complete feed or water for drinking for all animal species. No concerns for consumers and the environment were identified following the use of the additives to the highest safe level in feed. The additives under assessment should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. Since the berries of J. communis and their preparations are recognised to flavour food and their function in feed would be 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 lactic acid produced by fermentation using a strain of Weizmannia coagulans (DSM 32789). The additive is intended to be used as a technological additive, functional group preservatives, in complete feed and water for drinking for all animal species except for fish. In a previous opinion, the FEEDAP Panel concluded that the production strain qualified for the qualified presumption of safety (QPS) approach for safety assessment. Uncertainty remained concerning the possible presence of viable cells and/or spores of the production strain in the final product, however, the presence of viable cells of a QPS strain would not raise safety concerns for the target species, humans, and the environment. The applicant has provided additional information in the form of a scientific report to support the absence of viable cells and/or spores in the final product. Based on the data provided, the FEEDAP Panel concluded that the final product contains no viable cells and/or spores of the production microorganism.

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of lignosulphonate, when used as a technological additive (functional group: binders) in feed for all animal species. In two previous assessments, the FEEDAP Panel concluded that the maximum level proposed of 10,000 mg lignosulphonate/kg complete feed is safe for weaned piglets, pigs for fattening, chickens for fattening, laying hens and cattle for fattening, but a margin of safety could not be identified. Consequently, these conclusions could not be extrapolated to other animal species/categories. In the current application, the applicant proposed to reduce the maximum content of lignosulphonate in feed for all animal species to 8,000 mg/kg complete feed. The results of two newly submitted tolerance studies allowed the Panel to conclude that 8,000 mg lignosulphonate/kg complete feed is also safe for dairy cows and salmonids, with a margin of safety of at least 1.25. Considering the results of the studies previously assessed and those of the two new tolerance studies, the FEEDAP Panel concluded that lignosulphonate is safe for all animal species when used at a maximum content of 8,000 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 a tincture from the fruit of Pimpinella anisum L. (anise tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.6%. The product contained on average 0.0414% polyphenols (of which 0.0144% were flavonoids), 0.0009% anisaldehyde, 0.0003% anethole. Estragole (≤ 1.2 mg/kg) was detected in the additive. The estimated maximum content of furocoumarins was 8.2 mg/kg. The use of the anise tincture in feed was not expected to increase the exposure to furocoumarins of those target species that are already fed citrus by‐products to a relevant extent (

Abstract Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat halofuginone hydrobromide (STENOROL®) when used as a feed additive for chickens for fattening and turkeys for fattening/reared for breeding. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the safety for turkeys for fattening established in its previous opinion can be extended to turkeys for breeding up to 12 weeks of age. Based on the new data provided on the safety for consumer, environment and efficacy, the Panel updates its previous conclusions as follows: halofuginone hydrobromide is not genotoxic. Applying an uncertainty factor of 100 to the lowest no observed adverse effect level (NOAEL) of 0.03 mg/kg body weight (bw) per day, an acceptable daily intake (ADI) of 0.3 μg halofuginone/kg bw is established. The chronic exposure of consumers to residues of halofuginone would amount to 6–19% of the ADI after 3 days of withdrawal. Therefore, the Panel considers that the additive is safe for the consumer of tissues obtained from chickens for fattening and turkeys for fattening fed the additive at a maximum level of 3 mg/kg complete feed at a 3‐day withdrawal time. For control purposes, the Panel recommends the setting of the following maximum residue limits (MRLs): liver, 50 μg/kg; kidney, 40 μg/kg; muscle, 3 μg/kg; skin/fat, 10 μg/kg wet tissue. Based on an updated environmental risk assessment, no concern for groundwater is expected. Halofuginone is unlikely to bioaccumulate and the risk of secondary poisoning is not likely to occur. No safety concerns are expected for terrestrial and aquatic environments. The additive has the potential to control coccidiosis in chickens for fattening and turkeys for fattening/reared for breeding up to 12 weeks of age at a minimum level of 2 mg/kg complete feed.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of disodium 5′‐inosinate (also known as inosine monophosphate, IMP) produced by Corynebacterium stationis KCCM 80235 as a sensory additive, functional group flavouring compounds, for all animal species. In 2022, the FEEDAP Panel 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, users and the environment due to uncertainties on the genetic basis of the streptomycin resistance of the production strain C. stationis KCCM 80235 and on the possible presence of its recombinant DNA in the final product. The applicant provided supplementary data which elucidated the genetic basis of the streptomycin resistance of the production strain and excluded the presence of its DNA in the final product. Therefore, the FEEDAP Panel concluded that IMP produced by C. stationis KCCM 80235 is safe for the target species, consumers, users and the environment. The FEEDAP Panel reiterated its previous concerns on the safety for the target species when using IMP in water for drinking due to hygienic reasons.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium and sodium ferrocyanide as technological feed additives for all animal species. The additives sodium‐ and potassium ferrocyanide are intended to be used in sodium chloride with a maximum content of 80 mg ferrocyanide anion (anhydrous)/kg salt. The FEEDAP Panel concluded that the use of sodium ferrocyanide and potassium ferrocyanide is safe, when added to sodium chloride at a maximum content of 80 mg ferrocyanide anion/kg for: turkey for fattening and laying hens and other laying/breeding birds; all porcine species and categories, all ruminant species and categories, rabbit, horse, salmonids and other minor fin fish, dogs and cats. In the absence of a margin of safety, the use of sodium and potassium chloride according to the proposed conditions of use is not considered to be safe for chickens for fattening and other poultry species for fattening or reared for laying/breeding other than turkeys. In the absence of information on the use of sodium chloride in the diets for any other animal species, no conclusion on a potentially safe level of sodium chloride, supplemented with 80 mg ferrocyanide anions (anhydrous)/kg, could be made. The use of sodium and potassium ferrocyanide in animal nutrition under the conditions of use proposed is of no concern for consumer safety. The results of in vivo studies showed that sodium and potassium ferrocyanide are not irritant to skin and eye and are not skin sensitisers. However, owing to the presence of nickel, sodium ferrocyanide, is considered a dermal and respiratory sensitiser. No conclusions could be reached on the safety of the user exposed via inhalation for potassium ferrocyanide. The use of sodium and potassium ferrocyanide as feed additives is considered safe for the environment. The additives are considered to be efficacious as anticaking agents in sodium chloride at the proposed use level.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species. In 2021, the FEEDAP Panel issued an opinion on the safety and efficacy of the product. In that assessment, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the genetically modified production organism in the additive. The applicant provided supplementary data to exclude the presence of recombinant DNA derived from the production organism in the final product. Based on the data provided, the FEEDAP Panel concluded that no DNA of the production strain C. glutamicum KCCM 80185 was detected in the additive.

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

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the feed additive consisting of robenidine hydrochloride (Cycostat® 66G) for rabbits for breeding and rabbits for fattening for the renewal of its authorisation. Since the potential aneugenic activity of robenidine hydrochloride cannot be excluded, the FEEDAP Panel is not in the position to conclude on the safety of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety of robenidine hydrochloride for the environment. Robenidine hydrochloride has potential for bioaccumulation; however, a risk for secondary poisoning for worm/fish‐eating birds and mammals is not likely to occur. No concern for groundwater is expected. Robenidine hydrochloride is not a skin or eye irritant and not a skin sensitiser. Due to the lack of data on the genotoxicity (aneugenicity) of the substance, the exposure to the additive of the unprotected users should be minimised. Owing to the lack of sufficient data, the FEEDAP Panel cannot conclude that robenidine hydrochloride from Cycostat® 66G is still efficacious against recent Eimeria spp. strains in rabbits.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of semi‐refined carrageenan as a feed additive for cats and dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that semi‐refined carrageenan was safe for dogs at 6,000 mg/kg final wet feed (with about 20% dry matter). This would correspond to 26,400 mg semi‐refined carrageenan/kg complete feed (with 88% dry matter). In the absence of specific data, the maximum concentration of the additive considered safe for cats was 750 mg semi‐refined carrageenan/kg final wet feed, corresponding to 3,300 mg semi‐refined carrageenan/kg complete feed (with 88% dry matter). In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of carrageenan for the user. The additive under assessment is intended to be used in dogs and cats only. No environmental risk assessment was considered necessary for such use. The FEEDAP Panel was not in the position to conclude on the efficacy of semi‐refined carrageenan as a gelling agent, thickener and stabiliser in feed for cats and dogs at the proposed conditions of use.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of two bacilli strains (tradename: BioPlus® 2B) when used in suckling piglets, calves for fattening and other growing ruminants. BioPlus® 2B is composed of viable cells of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749. In the course of the current assessment, the latest strain was reclassified as Bacillus paralicheniformis. BioPlus® 2B is intended for use in feedingstuffs and water for drinking for the target species at the minimum inclusion level of 1.3 × 109 CFU/kg feed and 6.4 × 108 CFU/l water, respectively. B. paralicheniformis and B. subtilis are considered eligible for the qualified presumption of safety (QPS) approach. The identity of the active agents was established, and the qualifications regarding the lack of acquired antimicrobial resistance genes, toxigenic potential and bacitracin production ability were complied with. Following the QPS approach, B. paralicheniformis DSM 5749 and B. subtilis DSM 5750 are presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, BioPlus® 2B was also considered safe for the target species, consumers and the environment. BioPlus® 2B is not irritant to the eyes or skin but should be considered a respiratory sensitiser. The Panel could not conclude on the skin sensitisation potential of the additive. BioPlus® 2B when supplemented at 1.3 × 109 CFU/kg complete feed and 6.4 × 108 CFU/l water for drinking has the potential to be efficacious in suckling piglets, calves for fattening and other growing ruminants (e.g. sheep, goat, buffalo) at the same developmental stage.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a pancreatic extract (Pan‐zoot) as a zootechnical additive for dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of Pan‐Zoot as a feed additive for dogs under the proposed conditions of use. The FEEDAP Panel could not conclude on the skin/eye irritancy potential of the additive or on the dermal sensitisation potential. Owing to its proteinaceous nature, the additive is considered a respiratory sensitiser. The additive may induce allergic reactions to the exposed users. The Panel concluded that there is no need for an environmental risk assessment. The FEEDAP Panel could not conclude on the efficacy of the product as a feed additive at the recommended conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of four bacteriophages infecting Salmonella enterica ser. Gallinarum B/00111, intended to be used as a zootechnical additive (functional group: other zootechnical additives) for all avian species. The additive (tradename Bafasal®) is not currently authorised in the European Union. Bafasal® is intended to be used 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 a previous opinion, the FEEDAP Panel could not conclude on the additive's potential to be irritant or a dermal sensitiser, or on its efficacy for any avian species due to insufficient data. The applicant provided supplementary information to address these data gaps. The new data showed that Bafasal® is not a skin or eye irritant. No conclusions could be drawn on its skin sensitisation potential. The Panel was not in the position to conclude on the efficacy of Bafasal® to improve the zootechnical performance of the target species based on the available data. The additive showed the potential to decrease the counts of two strains of Salmonella Enteritidis in boots swabs and caecal digesta of chickens for fattening. No conclusions could be drawn on the capacity of Bafasal® to reduce the contamination of other Salmonella enterica strains, serovars or other species of Salmonella. The potential of Bafasal® to reduce the Salmonella spp. contamination poultry carcasses and/or the environment is limited. The FEEDAP Panel recommended a post‐market monitoring plan to address the potential selection and spread of resistant variants of Salmonella to Bafasal®.

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 an essential oil from the leaves of Laurus nobilis L. (laurel leaf oil), when used as a sensory additive for all animal species. The additive contains up to 4% methyleugenol. The use of the additive at 2 mg/kg complete feed in dogs and cats was considered of low concern. For other long‐living and reproductive animals, the use of the additive at 10 mg/kg was considered of concern. For short‐living animals, the Panel had no safety concern when the additive is used at 10 mg/kg complete feed for turkeys for fattening, piglets and other growing Suidae, pigs for fattening, veal calves (milk replacer), cattle for fattening and other growing ruminants, horses and rabbits for meat production, salmonids and other fin fish; and at 8.5 mg/kg for chickens for fattening, other growing poultry and other minor species for fattening. The use of laurel leaf oil up to the highest level in feed which was considered of no concern for target animals was also expected to be of no concern for consumers. The additive should be considered as irritant to skin and eyes and the respiratory tract. Due to the high concentration of methyleugenol (≥ 1%), the additive was classified by the applicant as suspected of causing genetic defects and of causing cancer and should be handled accordingly. The use of the additive under the proposed conditions of use was not expected to pose a risk for the environment. Since the leaves of L. nobilis and their preparations were recognised to flavour food and their function in feed would be the same, 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 safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp.CNCM I‐3699 intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed for chickens for fattening to improve their performance. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 viable forming units (VFU)/g additive. However, in that opinion, the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address the missing information for the characterisation of the additive. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. Sorbiflore® ADVANCE is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Pediococcus pentosaceus DSM 23376, as a technological additive to improve ensiling of forage for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive is not irritant to skin or eyes but owing to its proteinaceous nature, it should be considered a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of the preparation consisting of viable cells of Bacillus subtilis CNCM I‐4606, B. subtilis CNCM I‐5043, B. subtilis CNCM I‐4607 and Lactococcus lactis CNCM I‐4609 when used as a technological additive (hygiene condition enhancer) for all animal species. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for the target species, consumers and the environment. The Panel also considered the additive to be non‐irritant to skin and eyes, nor a dermal sensitiser, but a respiratory sensitiser. Moreover, the data provided were not sufficient to conclude on the efficacy of the additive to significantly reduce the growth of Salmonella Typhimurium or Escherichia coli in feed. In the current assessment, the applicant provided supplementary information to address these flaws and limited the claimed effect to ‘prevent (re)contamination by Salmonella Typhimurium’. Based on the new studies, the Panel concluded that the additive at a minimum proposed inclusion level of 1 × 109 colony forming units (CFU) B. subtilis and 1 × 109 CFU L. lactis per litre showed potential to reduce Salmonella Typhimurium growth in feeds with high moisture content (60–90% moisture).

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 intended to be used as a technological additive (functional group: silage additives) in forage for all species. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 Viable Forming Units (VFU)/g additive. However, in that opinion the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address these gaps. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. The additive is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive. The Panel reiterated its previous conclusions that no conclusions can be drawn on the efficacy of the additive to improve the ensiling process of forage.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 2‐acetylfuran [13.054] and 2‐pentylfuran [13.059] belonging to chemical group 14 (furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms), when used as sensory additives (flavourings) in feed for all animal species. 2‐Acetylfuran [13.054] was tested in tolerance studies in chickens for fattening, weaned piglets and cattle for fattening. No adverse effects were observed in the tolerance studies at 10‐fold the intended use level. The FEEDAP Panel concluded that 2‐acetylfuran [13.054] is safe for these species at the proposed use level of 0.5 mg/kg and conclusions were extrapolated to all animal species. For 2‐pentylfuran [13.059], the Panel concluded that it is safe at the proposed maximum use level in feed of 0.5 mg/kg. No safety concern would arise for the consumer from the use of 2‐acetylfuran [13.054] and 2‐pentylfuran [13.059] up to the proposed maximum use level in feed as flavourings. The additives should be considered as irritant to skin and eyes and the respiratory tract, and as dermal and respiratory sensitisers. The use of 2‐acetylfuran [13.054] and 2‐pentylfuran [13.059] as flavours in animal feed was not expected to pose a risk for the environment. Since the compounds under assessment are used in food as flavourings and their function in feed is 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 endo‐1,4‐β‐d‐mannanase (Hemicell® HT/HT‐L) produced by a genetically‐modified strain of Paenibacillus lentus (DSM 33618) as a zootechnical feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, piglets (weaned) and minor porcine species. The production strain was obtained from a Paenibacillus lentus recipient strain that has been evaluated previously by EFSA and considered to be safe. The genetic modification does not raise safety concerns and there were no antibiotic resistance genes from the genetic modification in the production strain. Viable cells and the DNA of the production strain were not found in the intermediate product used to formulate the additive. Hemicell® HT/HT‐L produced by Paenibacillus lentus DSM 33618 is considered safe for the above‐mentioned target species at the intended conditions of use. The use of Hemicell® HT/HT‐L as a feed additive raises no concerns for the consumer or for the environment. Hemicell® HT/HT‐L is not irritant to the skin and eyes but is regarded as a dermal sensitiser and a potential respiratory sensitiser. The additive has a potential to be efficacious at 32,000 U/kg in chickens for fattening, chickens reared for laying, minor poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species, and at 48,000 U/kg in turkeys for fattening, turkeys reared for breeding and weaned piglets.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lentilactobacillus diolivorans (formerly Lactobacillus diolivorans) DSM 33625 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. The bacterial species L. diolivorans 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 a skin or an eye irritant. In the absence of data, no conclusion can be drawn on the skin sensitisation of the additive. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The FEEDAP Panel concluded that Lentilactobacillus diolivorans DSM 33625 at a minimum concentration of 1 × 108 CFU/kg forage may extend the aerobic stability of silage prepared from easy and moderately difficult to ensile forage material 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 endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525, Axtra® XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the ■■■■■ used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase. Moreover, the Panel could not conclude on the efficacy in laying hens. The applicant submitted some new information to address some of the limitations previously identified. Moreover, the applicant declared a change in the production strain of the protease, substituting B. subtilis ATCC SD‐2107 for B. subtilis CBS 148232. The Panel concluded that the additive is safe for the target species at the recommended use level (1,000 xylanase U, 100 amylase U and 2,000 protease U per kg feed). The additive is safe for the consumers of food products obtained from animals fed with the additive and raises no concerns for the environment. The Panel could not conclude on the skin/eye irritancy potential of the additive nor on its dermal sensitisation potential. Owing to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level). Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of urea as nutritional feed additive. The additive is authorised for use in ruminants with functional rumen (3d1). The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been substantially modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the target species, consumer and for the environment when used as a source of non‐protein nitrogen under current conditions of use, in ruminants with functional rumen. In the absence of new data, the FEEDAP Panel is not in the position to conclude on the user safety. The Panel retains that 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 zinc(II)–betaine complex as nutritional additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion could be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded. The FEEDAP Panel concluded that the use of the zinc(II)–betaine complex in animal nutrition is of no concern for consumer safety provided that the maximum authorised total zinc levels in feed are respected. The additive is considered to be a skin and respiratory sensitiser due to the presence of nickel; it is irritant to the eyes, but not to the skin. The use of the additive in animal nutrition for terrestrial animals and land‐based aquaculture at the proposed use levels is considered safe for terrestrial and aquatic ecosystems. The available data do not allow the conclusion to be made on the safety of the additive for the marine sediment when it is used in sea cages. Based on the deposition of zinc in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable zinc, comparable to the standard inorganic zinc source, and therefore, the additive is efficacious in meeting the birds zinc requirements. This conclusion can be extrapolated to all animal species and categories.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of a tincture derived from Gentiana lutea L. (gentian tincture). It is intended to be used as a sensory additive for all animal species. The product is a water/ethanol solution, with a dry matter content of approximately 4.3% and it contains on average 0.0836% polyphenols (of which 0.0463% are flavonoids and 0.0027% xanthones) and 0.0022% gentiopicroside. The additive is intended for use in complete feed or drinking water up to a maximum level of 50 mg tincture/kg for all animal species, except horses, for which the proposed use is 200 mg/kg in complete feed. In a previous assessment, due to the genotoxic potential identified in vitro for xanthones (gentisin and isogentisin) and gentiopicroside the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for long‐living animals and on risks of genotoxicity and carcinogenicity for dermal exposure of unprotected users. The additive did not raise safety concern for short‐living animals, consumers and the environment. The applicant has provided information in the form of literature to address the previously identified genotoxic activity of xanthones and gentiopicroside and the risk for the user. Considering that the literature identified provided no new evidence, the FEEDAP Panel reiterated that it is not in a position to conclude on the safety of the additive for long‐living and reproductive animals. No conclusions could be drawn on the potential of the additive to be a dermal/eye irritant or a skin sensitiser. When handling the tincture, exposure of unprotected users to xanthones (gentisin and isogentisin) and gentiopicroside cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised.

Abstract The additive Miya‐Gold® consists of viable cells of Clostridium butyricum FERM BP‐2789.The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and piglets of minor porcine species. The authorisation for chickens and minor poultry species for fattening and reared for laying is at a minimum level of 2.5 × 108 CFU/kg complete feed. The applicant has requested to lower this level to 1.25 × 108 CFU/kg feed. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) did not consider any of the five long‐term trials and one pooled analysis of two of them as supporting evidence for the efficacy of the additive at the lower dose due to the incompliance of the husbandry conditions in which the chickens were reared with those indicated in Directive 2007/43/EC. Owing to the lack of adequate data, the Panel is not in the position to conclude on the efficacy of Miya‐Gold® at 1.25 × 108 CFU/kg feed 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 Streptococcus salivarius DSM 13084/ATCC BAA 1024 as a technological additive (functional group: acidity regulators) in feed for dogs and cats. The additive is intended for use at a proposed minimum concentration of 1 × 1011 CFU/l or kg liquid feed for dogs and cats. Due to the lack of adequate data, the FEEDAP Panel could not conclude on the safety of the additive for the target species. The additive was considered a respiratory sensitiser, but not irritant to skin. No conclusions could be drawn on the potential of the additive to be an eye irritant or a skin sensitiser. No environmental risk assessment is necessary for the use of the additive in feeds for pets. The Panel concluded that the additive has the potential to be efficacious in feeds for dogs and cats at the proposed conditions of use.

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of Eleutherococcus senticosus (Rupr. & Maxim.) Maxim. (taiga root tincture) when used as a sensory additive in feed for dogs, cats and horses. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for dogs, cats and horses at the maximum proposed use level of 460.7, 489.5 and 140.7 mg/kg complete feed, respectively. The additive was considered safe for consumers when used at the proposed conditions of use in horses for meat production. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the taiga root tincture as a flavour in feed for horses was not expected to pose a risk for the environment. Since the root of E. senticosus has flavouring properties and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the tincture under assessment.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐d‐mannanase produced by Thermothelomyces thermophilus DSM 33149 (Natupulse® TS/TS L) as a zootechnical feed additive for chickens and turkeys for fattening, minor poultry species for fattening and ornamental birds. The additive under assessment, Natupulse® TS/TS L, does not pose any safety concern regarding the production strain. The FEEDAP Panel concluded that the additive is tolerated by chickens for fattening, and this conclusion can be extrapolated to all poultry for fattening. Due to the lack of reliable data regarding the potential of the additive to induce chromosomal damage, the FEEDAP Panel cannot conclude on the safety of the additive for the target species and on the safety for consumer. The use of the additive in animal nutrition is considered safe for the environment. The additive is considered not to be irritant to the skin and eyes but is considered a respiratory sensitiser, although exposure by inhalation is unlikely. The Panel could not conclude on the potential of the additive to be a skin sensitiser. Due to the lack of reliable data, the FEEDAP Panel considered that a potential of the additive to induce chromosomal damage in exposed unprotected users cannot be excluded. Consequently, exposure of users should be minimised. The Panel concluded that the additive Natupulse® TS/TS L has the potential to be efficacious in chickens for fattening at the proposed conditions of use and this conclusion can be extrapolated to turkeys for fattening, minor poultry species for fattening and ornamental birds.