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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a new preparation of zinc-l-selenomethionine, with selenium content of 4%, as a nutritional feed additive for all animal species. Zinc-l-selenomethionine is already authorised for use in all animal species (3b818). Current authorisation defines the additive as 'Solid preparation of zinc-l-selenomethionine with a selenium content of 1-2 g/kg'. The applicant developed a new preparation of zinc-l-selenomethionine containing a minimum of 40 g Se/kg and seeks to modify the current authorisation. The FEEDAP Panel concluded that the newly proposed preparation is considered safe for all animal species. The FEEDAP Panel recommends adding, to the currently existing authorisation, a new preparation (40-46 g Se/kg) and not the range proposed by the applicant (1-46 g Se/kg), since no characterisation data on the intermediate preparation range (from 2 to 40 g Se/kg) have been provided. The use of the new preparation (minimum 40 g Se/kg) of zinc-l-selenomethionine in animal nutrition is of no concern for consumer safety. The newly proposed preparation presents a risk by inhalation; it is not irritant to eyes or skin. No conclusion can be reached regarding dermal sensitisation. The previous conclusion by the Panel on the safety for the environment remains unchanged. The Panel concluded that the modification request has no impact on efficacy., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Pediococcus acidilactici CNCM I-4622 as a zootechnical additive (functional group: physiological condition stabilisers) for all insects. The active agent used in the additive is already authorised for use in all animal species as a technological additive, and as a zootechnical additive in all Suidae species for fattening and for breeding, other than sows, all avian species, all fish species and all crustaceans. The active agent has been identified as a strain of P. acidilactici and consequently meets the qualifications required by the qualified presumption of safety (QPS) approach. The use of the additive is considered safe for all insect species, consumers and the environment. The additive is considered non-irritant to skin and eyes but a respiratory sensitiser. No conclusions can be drawn regarding its skin sensitisation potential. In the absence of adequate data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive as a physiological condition stabiliser for honeybees nor for all insect species., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Levilactobacillus brevis (formerly Lactobacillus brevis ) DSM 23231 as a technological feed additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that evidence has been provided that the additive currently on the market complies with the existing terms of authorisation. The Panel also concluded that L. brevis DSM 23231 remains safe for all animal species, consumers and the environment under the authorised conditions of use. The additive should be considered a respiratory sensitiser. Based on the studies submitted regarding user safety, the preparation of the additive tested was shown not to be a skin or eye irritant. The Panel was not in the position to conclude 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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 copper(II)-betaine as a nutritional additive for all animal species and on the safety for the marine sediment when the additive is used in sea cages. The FEEDAP Panel concluded that the risk to the marine sediment is acceptable when the additive is used in sea cages. The additional statistical analysis of the results of the efficacy study already assessed in the previous opinion did not allow the Panel to conclude on the efficacy of the additive., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zeolites (≥ 50%) obtained from Neapolitan Yellow Tufa as a technological additive (functional group: anticaking) for all animal species. The additive is specified to contain not less than 50% of zeolites, namely phillipsite, chabazite and analcime. Neapolitan Yellow Tufa originates from the volcanic activity of Campi Flegrei, Italy. According to the conventional risk assessment, due to a lack of adequate data, the safety of the additive for the target species cannot be established. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and, therefore, of concern for the consumer. The additive poses a risk by inhalation. It is not irritant to the skin. The Panel cannot conclude on the eye irritancy and on the dermal and respiratory sensitisation potential of the additive. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles for the target species, the consumer and the user could not be assessed. The additive is safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species at 20,000 mg/kg complete feed., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Availa®Cr (active compound: chromium chelate of dl-methionine) as a feed additive for dairy cows. In a previous opinion, the FEEDAP Panel concluded that Availa®Cr at a maximum recommended use level of 0.5 mg Cr(III) (8 mg Cr from Availa®Cr/cow per day) was safe for dairy cows and the consumers. Additionally, the FEEDAP Panel considered that the additives posed a risk to the user by inhalation, it was not irritant to skin and eyes, and it should be considered a skin sensitiser. The Panel could not conclude on the efficacy of the additive at the proposed conditions of use. Since the new information provided in the current application is lacking sufficient evidence, the FEEDAP Panel is still not in the position to conclude on the efficacy of chromium dl-methionine from Availa®Cr., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of benzoic acid (Kalama®) as a zootechnical feed additive for weaned piglets at a level of 5000 mg/kg complete feed and for pigs for fattening at a minimum content of 5000 mg/kg and a maximum content of 10,000 mg/kg complete feed. The FEEDAP Panel concluded that benzoic acid is safe for weaned piglets at 5000 mg/kg complete feed and for pigs for fattening at 10,000 mg/kg complete feed. The Panel considered the use of benzoic acid under the proposed conditions of use to be of no concern for consumer safety and the environment. Benzoic acid poses a risk by inhalation, it is irritant to skin and corrosive to eyes, but no conclusions can be drawn on dermal sensitisation. The additive, benzoic acid, is efficacious as a zootechnical feed additive for weaned piglets and for pigs for fattening at the proposed conditions of use., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 folic acid as a nutritional feed additive. The additive is authorised for use in feed and water for drinking for all animal species. 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 modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the safety for the terrestrial species, consumers and for the environment. The use of folic acid in aquatic animal species to cover their nutritional needs is considered safe. However, the Panel is not in a position to set a maximum safe level for all fish and crustacean species. Considering the narrow margin between the requirement and the tolerated levels seen in some aquatic animal species, the FEEDAP Panel considers that supplementation should not exceed the requirements of the different aquatic animal species. The additive is neither a skin irritant nor a dermal sensitiser. The exposure through inhalation is likely. Due to the lack of data, the FEEDAP Panel is not in the position to conclude on the potential of folic acid to be harmful to the respiratory system and irritant to eyes. The Panel retains that the previously made conclusion on the efficacy remains valid., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 for the environment of the coccidiostat semduramicin sodium (Aviax 5%) when used in feed for chickens for fattening. The additive Aviax 5% is intended to be used as a coccidiostat in feed for chickens for fattening at a level of 20-25 mg semduramicin sodium/ kg complete feed. The safety and efficacy of the additive was evaluated by the FEEDAP Panel in 2018 and 2022. In those opinions it was concluded that the additive is safe for the target species and consumer, while no conclusions could be made on the irritancy of Aviax 5% to skin and eye and on the potential for dermal and respiratory sensitisation. Regarding the safety for the environment, the Panel concluded that a risk for the terrestrial compartment could not be excluded. Based on new data submitted, no risk is expected from the use of the additive in animal nutrition at the proposed conditions of use for the terrestrial compartment. The previous conclusions of the FEEDAP Panel on the safety of the additive for the environment can be updated as follows: the use of semduramicin sodium from Aviax 5% in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for groundwater nor for aquatic, terrestrial and sediment compartments., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

This guidance document is intended to assist the applicant in the preparation and the presentation of 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 safety for the users., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive for weaned piglets, calves for fattening and calves for rearing. The product under assessment is based on a strain originally identified as Enterococcus faecium . During the current assessment, the active agent has been reclassified as Enterococcus lactis . The additive currently authorised is marketed in two formulations: Lactiferm Basic 50 (a solid formulation to be used in feed), and Lactiferm WS200 (a solid 'water-soluble' formulation to be used in water for drinking). The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concludes that the use of Lactiferm® under the authorised conditions of use remains safe for the target species (calves up to 6 months and weaned piglets up to 35 kg), consumers and the environment. The Lactiferm WS200 formulation of the additive is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It is not possible to conclude on the irritating potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both forms of the additive to cause skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 a feed additive consisting of Duddingtonia flagrans NCIMB 30336 (BioWorma®) for all grazing animals. The safety and efficacy of the additive have been already assessed previously, however the FEEDAP Panel could not conclude on the safety of the additive for the target species and the consumers due to the limitations in the dataset provided. For the current assessment, the applicant submitted a new tolerance trial in dairy cows and new toxicological studies. After the assessment of the new data submitted, the FEEDAP Panel concluded that the use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for dairy cows. This conclusion can be extrapolated to all dairy bovines, ovines and caprines, but not to fattening and rearing animals of those species. Due to the lack of data, the FEEDAP Panel cannot conclude on the safety of the additive for other grazing species/categories. The FEEDAP Panel concluded that the additive is safe for the consumers., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 (BIO-THREE®) as a zootechnical feed additive to be used as a gut flora stabiliser for chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, and all avian species for rearing/fattening or reared for laying/breeding. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of BIO-THREE® for the target species at the proposed conditions of use. The applicant has provided a new study in chickens for fattening as supplementary information to support the efficacy of BIO-THREE® for the target species. Considering the previously submitted studies and the new submitted trial, the Panel concluded that the additive is efficacious for chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, and all avian species for rearing/fattening or reared for laying/breeding under the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Weizmannia faecalis (formerly identified as Bacillus coagulans ) DSM 32016 (TechnoSpore50®) as a zootechnical feed additive for poultry reared for breeding/laying/fattening, ornamental birds and suckling and weaned Suidae piglets. The additive is authorised for use in feed for poultry for fattening, ornamental birds and suckling and weaned Suidae piglets. This application sought the extension of use in feed for poultry reared for breeding/laying and the new authorisation in water for drinking for suckling and weaned Suidae piglets, poultry for fattening, reared for breeding/laying and ornamental birds. Moreover, the applicant requested the authorisation of simultaneous use in feed for poultry reared for breeding and laying with coccidiostats. The identity and the lack of toxigenic activity of the active agent was confirmed, and it did not show resistance to relevant antibiotics; therefore, the strain was presumed safe for the target species, consumers and the environment. Since other components did not introduce concerns, TechnoSpore50® was also considered safe for the target species, consumers and the environment. The additive is not a skin/eye irritant but is a respiratory sensitiser. No conclusions could be drawn on the skin sensitisation potential of the additive. TechnoSpore50® was considered to be efficacious in feed for poultry reared for laying/breeding at 1 × 10 9  CFU/kg and in water for drinking for poultry reared for fattening, poultry reared for laying/breeding, ornamental birds and for suckling and weaned Suidae piglets at 5 × 10 8  CFU/L. TechnoSpore50® is compatible with halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium and monensin sodium + nicarbazin, but not with narasin or narasin + nicarbazin. No conclusions could be drawn on the compatibility of TechnoSpore50® with decoquinate, lasalocid A sodium, semduramicin sodium, nicarbazin or amprolium hydrochloride., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of Cylactin® as zootechnical additive. The active agent of the additive is Enterococcus lactis NCIMB 10415, and three additive formulations currently authorised: Cylactin® LBC G35, Cylactin® LBC ME10 and Cylactin® LBC ME20 plus. The additive is currently authorised in the EU for use in poultry (chickens and minor poultry species for fattening, chickens and minor species reared for laying), calves and kids for rearing and for fattening, sows, suckling and weaned piglets and pigs for fattening. The applicant is now seeking the renewal of its authorisation and the extension of use for chickens and minor poultry species reared for breeding, turkeys for fattening and reared for breeding, ornamental birds, lambs for rearing and for fattening, minor or other ruminants' species for rearing and fattening, minor suckling and weaned Suidae species, pigs and minor Suidae species for fattening, rearing or reproduction. In addition, the applicant is seeking authorisation for use in water for drinking for all above-mentioned target species and categories. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The FEEDAP Panel concludes that the additive is safe for the target animals, consumers and the environment under the authorised/new proposed conditions of use. The Cylactin® LBC ME10 and LBC ME20 plus are not skin and eye irritants, but no conclusion could be drawn on the potential of Cylactin® LBC G35 to be skin and eye irritant. Moreover, no conclusions could be drawn on the additive skin sensitisation potential. The additive is considered a potential respiratory sensitiser. The efficacy for the new target species/categories as well its use in water was extrapolated from the previous efficacy studies., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 fruit of Coriandrum sativum L. (coriander oil), when used as a sensory additive in feed for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of coriander oil is safe up to the maximum proposed use levels of 30 mg/kg complete feed for piglets, pigs for fattening, sows, veal calves (milk replacer), cattle for fattening, sheep, goats and horses, salmonids, dogs and ornamental fish. For the other species, the calculated safe concentrations in complete feed are: 14 mg/kg for chickens for fattening, 28 mg/kg for laying hens, 26 mg/kg for turkeys for fattening, 28 mg/kg for rabbits and 14 mg/kg for cats. These conclusions were extrapolated to physiologically related species. For any other species, the additive was considered safe at 14 mg/kg complete feed. The proposed conditions of use for veal calves (10 mg/kg) and ruminants, horses and dogs (5 mg/kg) were considered safe provided that the use in water for drinking alone or in combination with the use in feed should not exceed the daily amount that is considered safe when consumed via feed alone. No concerns for consumers and the environment were identified following the use of coriander oil up to the maximum proposed use level in feed. Coriander oil should be considered as irritant to skin and eyes and the respiratory tract and as a dermal and respiratory sensitiser. Since C. sativum and its preparations are 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6-phytase produced by Komagataella phaffii CGMCC 7.19 (Nutrase P) as a zootechnical feed additive for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds. In a previous opinion, the FEEDAP Panel concluded on the efficacy of Nutrase P for the target species at the level of 1,500 phytase units (FTU)/kg but could not conclude at the minimum recommended use level of 500 FTU/kg complete feed. The applicant has provided supplementary information, consisting in the statistical re-analysis of the long-term study assessed in the original opinion, in order to support the efficacy of the additive at the minimum recommended level of 500 FTU/kg complete feed. Considering the previously submitted studies and the re-analysis of the long-term study, the Panel concluded that the additive has a potential to be efficacious for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds under the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of essential oils from fruit and stems of Foeniculum vulgare Mill. (bitter fennel oil and sweet fennel oil), when used as sensory additives (flavourings). For long-living and reproductive animals, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered of low concern the use of bitter fennel oil (with a content of estragole up to 6.1%) at the proposed use level in complete feed: 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.5 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 7.1 mg/kg for ornamental fish. For short-living animals (animals for fattening), the Panel had no safety concern when bitter fennel oil is used at the proposed use level in complete feed of 18.2 mg/kg for chickens for fattening, 24.3 mg/kg for turkeys for fattening and 25 mg/kg for piglets, pigs for fattening, veal calves, cattle for fattening, sheep/goats, horses, rabbits and salmon. These conclusions were extrapolated to other physiologically related species. The use of sweet fennel oil (with a content of estragole up to 5.0%) was considered of low concern at the proposed use level in complete feed of 2.3 mg/kg for dogs and 1.9 mg/kg cats. The use of bitter fennel oil in animal feed is expected to be of no concern for consumers and the environment. 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%), fennel oils are classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of F. vulgare Mill. ssp. vulgare and its preparations are recognised to flavour food, no further demonstration of efficacy was necessary., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lentilactobacillus buchneri DSM 19455 as a technological feed additive for use in easy and moderately difficult to ensile fresh material for all animal species. The Panel concluded that L. buchneri DSM 19455 remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, L. buchneri DSM 19455 was considered to be a respiratory sensitiser. The additive with inulin as a carrier tested is not irritant to skin and eyes. The Panel was not in the position to conclude 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 application for renewal of orthophosphoric acid as a technological additive (functional group: preservatives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species provided that the optimal Ca:P ratio is maintained. Additionally, the FEEDAP Panel concluded that orthophosphoric acid remains safe for the consumer and the environment under the authorised conditions of use. Regarding the user safety, orthophosphoric acid is corrosive to the skin and eyes and should be considered as hazardous to the respiratory tract. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 41 compounds to provide a Herbal flavour and belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fourteen out of the 41 compounds were tested in tolerance studies in chickens for fattening, piglets, cattle for fattening and Atlantic salmon. No adverse effects were observed in the tolerance studies at 10-fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 14 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 27 compounds, read-across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 27 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer and the environment from the use of the 41 compounds up to the maximum proposed use level in feed., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Bonvital® is the trade name for a feed additive currently authorised for use in piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). This opinion concerns the renewal of the authorisation of Bonvital® as a zootechnical additive for chickens reared for laying and minor poultry species other than those used for laying. The active agent of Bonvital® was originally identified as Enterococcus faecium . During the current assessment, the strain was reassigned to Enterococcus lactis . The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® was found to be non-irritant to skin and eyes, but a potential respiratory sensitiser. No conclusions could be drawn on the skin sensitisation potential of the additive. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese(II)-betaine complex as a nutritional feed additive for all animal species and categories. Based on the tolerance study performed in chickens, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the maximum proposed level of manganese in feed; this conclusion was extrapolated to all animal species and categories at the corresponding maximum manganese levels in complete feed (100 mg Mn/kg feed for fish and 150 mg Mn/kg feed for all other animal species). The FEEDAP Panel concluded that the use of additive in animal nutrition does not represent a concern for consumer safety or for the environment. The additive is irritant to the eyes, but not irritant to skin. Owing to the presence of nickel the additive is considered to be a dermal and respiratory sensitiser. The Panel concluded that the additive is efficacious as a nutritional additive for all animal species under the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of niacin (nicotinic acid) as a nutritional additive for use in 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 but is irritant to eyes. It is not a dermal sensitiser. Exposure through inhalation is likely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for particles below 50 μm from 1% to 5%. The FEEDAP Panel considers that the proposed modifications do not introduce concern for the safety for the target species and that the additive remains safe for the target species and the consumers when used up to the maximum authorised levels. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land-based aquaculture is considered safe under the proposed conditions of use. The data available do not allow the FEEDAP Panel to reach a conclusion on the safety of the additive for marine sediment when it is used in sea cages. The additive is not corrosive to skin, but is an eye and skin irritant. Due to the nickel presence, it is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum LMG P-21295, a technological additive to improve ensiling of fresh material 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. The Panel is not in the position to conclude on the skin and eye irritation potential of the additive. No conclusions can be drawn on the potential of the additive to cause skin sensitisation, but it is considered to be a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a fraction of the essential oil from the fruit and leaves of Illicium verum Hook.f. (star anise terpenes), when used as a feed additive for all animal species. The additive contains up to 25% estragole by specification and is obtained by a manufacturing process which results in the enrichment of this genotoxic carcinogen. This is not in line with the principles outlined in the general approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic when used as feed additives. Therefore, the FEEDAP Panel considered it was inappropriate to perform an assessment of the safety and efficacy of star anise terpenes for its use as a feed additive., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of niacinamide as a nutritional additive for use in 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 but irritant to eyes. It is not a dermal sensitiser. Exposure through inhalation is likely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The additive RONOZYME® WX (CT/L) contains endo-1,4-beta-xylanase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae ; the additive is currently authorised for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 26372 with A. oryzae DSM 33700, and to extend the use of the additive to all poultry species and all Suidae . RONOZYME® WX (CT/L), manufactured with the production strain A. oryzae DSM 33700, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its DNA were detected in an intermediate product representative of both final formulations of the additive. RONOZYME® WX (CT/L) was considered safe for all poultry species and all Suidae at the recommended inclusion levels. The use of RONOZYME® WX CT and L manufactured with the production strain A. oryzae DSM 33700 raised no concerns for consumers. RONOZYME® WX L is not an eye irritant; however, no conclusions could be drawn on the potential of RONOZYME® WX CT to be an eye irritant. Both formulations are not irritant to the skin, but due to the lack of data, the FEEDAP Panel was not able to conclude on the potential of both formulations of the additive to be skin sensitisers. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33700 raises no safety concerns for the environment. The additive has the potential to be efficacious in all poultry species and all Suidae at 100 and 200 FXU/kg complete feed, respectively., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 feed additive consisting of viable cells of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 (Biomin® C5) as a zootechnical additive (functional group: gut flora stabiliser) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying/breeding. Biomin® C5 is marketed in two formulations: a coated and a non-coated formulation with a total minimum microbial count of 1 × 10 11 and 4 × 10 10  colony forming unit (CFU)/g product, respectively. The Panel considered that the use of Biomin® C5 in feed at the proposed conditions of use raises no risk for the target species, consumers and the environment. Both coated and non-coated formulations of Biomin® C5 are considered respiratory and skin sensitisers, but not skin irritants. The FEEDAP Panel was not in the position to conclude on the eye irritation potential of any formulation. Due to lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of the additive in the target species at the proposed conditions of use. Biomin® C5 is compatible with nicarbazin, diclazuril, decoquinate and halofuginone. No conclusions can be drawn on the compatibility of Biomin® C5 with monensin sodium, robenidine hydrochloride, maduramicin ammonium and lasalocid A sodium., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Saccharomyces cerevisiae MUCL 39885 (Biosprint®) as a zootechnical additive for cats. The additive is already authorised for use in sows, dairy cows, horses, weaned piglets, dogs, cattle and minor ruminants for fattening and minor ruminants for dairy production. In a previous opinion, the FEEDAP Panel concluded that Biosprint® is safe when used in feeds for cats and dogs. However, based on the data available, the FEEDAP Panel was unable to conclude on the efficacy of the additive when administered to cats. In the current application, the applicant provided an additional efficacy trial in cats. Based on the previously and newly submitted data, the FEEDAP Panel concluded that Biosprint® has the potential to be efficacious as a zootechnical additive for cats under the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of K-9 Heritage Probiotic Blend® when used as a zootechnical additive (functional group: gut flora stabilisers) for dogs. The product under assessment is based on viable cells of Lacticaseibacillus casei IDAC 210415-01, Limosilactobacillus fermentum IDAC 210415-02, Levilactobacillus brevis IDAC 051120-02 and Enterococcus faecium IDAC 181218-03. The FEEDAP Panel was not in the position to conclude on the identification of the strains and, therefore, the safety of the product cannot be based on the presumption of safety of the active agents. The Panel notes that the use of E. faecium IDAC 181218-03 represents a safety concern because it harbours an acquired antimicrobial resistance gene. Moreover, the hazard related to the presence of additional antimicrobial resistance genes in the active agents cannot be excluded. No tolerance trials on the target animals have been provided. Therefore, the Panel is not in the position to conclude on the safety of the additive for dogs. Regarding the user safety, the Panel cannot conclude on the irritant potential of the additive for skin or eyes due to the absence of data. Given the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a skin sensitiser. The use of K-9 Heritage Probiotic Blend® in animal nutrition represents a safety concern for the environment due to the potential carryover of at least an antimicrobial resistance gene. The FEEDAP Panel is not in the position to conclude on the efficacy of K-9 Heritage Probiotic Blend® for the target species., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of the additive Provita LE for calves for rearing, consisting of Enterococcus lactis DSM 7134 (formerly identified as Enterococcus faecium ) and Lacticaseibacillus rhamnosus DSM 7133 (formerly identified as Lactobacillus rhamnosus ) as a zootechnical feed additive. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The FEEDAP Panel concluded that the use of the feed additive in animal nutrition remains safe for calves for rearing, consumers and the environment under the authorised conditions of use. The additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. It was not possible to draw conclusions on the skin sensitisation potential of the additive under assessment. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of sodium hydroxide as a technological additive (acidity regulator) for dogs, cats and ornamental fish. The applicants have provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species and the environment under the authorised conditions of use. Regarding user safety, the additive is corrosive and therefore the provision of the authorisation that 'breathing protection, eye protection, gloves and protective clothing shall be used during handling' should be confirmed. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of iron(II)-betaine complex as a nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chickens the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of iron in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum iron levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the iron(II)-betaine complex in animal nutrition at the maximum iron levels authorised for the animal species poses no concern to the safety of consumers. The additive is not a skin irritant, but it is an irritant to the eyes. Due to the traces of nickel, the additive is considered to be a respiratory and skin sensitiser. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals, land-based and sea cages aquaculture is considered safe under the proposed conditions of use. Based on the deposition of iron in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable iron, comparable to the standard inorganic iron source, and therefore, the additive is efficacious in meeting the birds iron requirements. This conclusion can be extrapolated to all animal species and categories., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit) as a zootechnical feed additive for all poultry species for fattening and reared for laying or for breeding. The additive is already authorised for use in feed and water for drinking for the above-mentioned species. With this application, the company requested the modification of the current authorisations as regards the simultaneous use of the additive with the coccidiostats monensin, salinomycin, narasin, nicarbazin+narasin and lasalocid. The proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of GalliPro® Fit. The additive is safe for the target species, consumers and the environment. The additive is not a dermal/eye irritant but should be considered a respiratory sensitiser. The FEEDAP Panel was not in the position to conclude on the skin sensitisation potential. The Panel concluded that GalliPro® Fit is compatible with the coccidiostats monensin, salinomycin, narasin, nicarbazin+narasin and lasalocid., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Agal-Pro BL/BL-L®. The additive is a preparation of alpha-galactosidase produced by a genetically modified strain of Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase produced by a non-genetically modified strain of Aspergillus niger (CBS 120604). It is intended to be used as a zootechnical additive (functional group: digestibility enhancers) in chickens for fattening in its solid and liquid forms (Agal-Pro BL® and Agal-Pro BL-L®), and in minor poultry species for fattening and chickens reared for laying only in its solid form (Agal-Pro BL®). 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 the target animals, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive is considered an irritant to the skin and eyes and a dermal sensitiser. Due to the proteinaceous nature of the active substances, it should be considered a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a protease (ProAct 360) produced by a genetically modified strain of Bacillus licheniformis (DSM 33099) as a zootechnical feed additive for poultry species for fattening or reared for laying/breeding. The production strain and its recombinant DNA were not detected in an intermediate concentrated product representative of the final formulation. The final product did not trigger a safety concern with regard to the genetic modification. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ProAct 360 is considered safe for all growing poultry species at the recommended inclusion level of 30,000 NFP/kg complete feed. The use ProAct 360 as a feed additive did not give rise to concerns for the consumers or the environment. The additive is not an eye or a dermal irritant but should be considered a respiratory sensitiser. In the absence of data, no conclusions could be reached on the skin sensitisation potential of the additive. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 30,000 NFP/kg complete feed for all poultry species for fattening or reared for laying/breeding., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 25-hydroxycholecalciferol as a feed additive for pigs and poultry. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive does not give raise to any safety concern regarding the production strain. Considering that the manufacturing process, the composition of the additive and its conditions of use have not been modified, the Panel considers that there is no evidence to reconsider the conclusions reached in the previous assessments. Therefore, the Panel concludes that 25-OH-D 3 remains safe for the target species, the consumer and the environment under the existing conditions of the authorisation. The additive is not irritant to the skin or eyes but no conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 feed additive containing endo-1,4-β-xylanase produced by Trichoderma citrinoviride DSM 34663 (Hostazym® X). The product is authorised as a zootechnical additive (digestibility enhancers) for use in all poultry species for fattening, for laying and reared for laying, weaned piglets, pigs for fattening and carp. The current opinion concerns the request for the renewal of the authorisation for the use in those species/categories and the extension of use to all poultry species for breeding and reared for breeding, ornamental birds, suckling piglets and minor porcine species for fattening. The applicant provided evidence that the additive 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 extension of use is made. The additive is considered not a skin corrosive or skin sensitiser, but it is an eye irritant. 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 in all poultry species, ornamental birds, all growing Suidae and carp at the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Lactiplantibacillus plantarum (previously Lactobacillus plantarum ) NCIMB 30083 as a technological additive, silage additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 25-hydroxycholecalciferol monohydrate produced with Saccharomyces cerevisiae CBS 146008 as a nutritional feed additive for all ruminants. The additive is already authorised for use with chickens for fattening, turkeys for fattening, other poultry and pigs. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not give raise to any safety concern regarding the production strain. The additive is safe for cattle for fattening and dairy cows at the maximum recommended use level of 0.1 mg 25-OH-D 3 /kg complete feed. This conclusion can be extended to other cattle categories and extrapolated to all ruminant species. The use of 25-OH-D 3 in all ruminants under the proposed conditions of use is considered safe for the consumer. The additive is not irritant to the skin or eyes. No conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. The use of the additive under assessment at the recommended conditions of use is considered safe for the environment. 25-OH-D 3 is an efficient source of vitamin D 3 for all ruminants when used according to the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 endo-β-1,4-xylanase (VTR-xylanase) as a zootechnical feed additive for all avian species, piglets (suckling and weaned) and minor growing porcine species. VTR-xylanase is available in a powder and a liquid form and is produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.371). 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 additive does not pose any safety concern regarding the production strain. VTR xylanase (powder/liquid) produced by Komagataella phaffii CGMCC 7.371 is safe for all avian species, piglets and minor growing porcine species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid and powder formulations of VTR-xylanase are non-irritant to eyes but should be considered skin sensitisers. No conclusions can be drawn on the potential of the final formulations of the additive to be irritant to skin. Due to the proteinaceous nature of the active substance, the additive is a respiratory sensitiser. The additive has the potential to be efficacious in all laying birds and piglets (suckling and weaned) from all Suidae at 2,000 U/kg and in all other avian species/categories at 1,000 U/kg feed., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of star anise oil from the fruit (without or with the presence of plant leaves) of Illicium verum Hook.f., when used as a sensory additive in feed and water for drinking for all animal species. For long-living and reproductive animals, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered of low concern the use of the additive in complete feed at 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.6 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 6.5 mg/kg for ornamental fish. For short-living animals, the Panel had no safety concern when the additive is used at 83.3 mg/kg for veal calves, 73.3 mg/kg for sheep/goats, cattle for fattening and horses for meat production, 83.8 mg/kg for salmonids, 24.8 mg/kg for turkeys for fattening, 18.5 mg/kg chickens for fattening, 33.3 mg/kg for piglets, 40 mg/kg for pigs for fattening and 29.3 mg/kg for rabbits for meat production. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered of low concern at 0.6 mg/kg. The use of star anise oil in animal feed is expected to be of no concern for consumers and for the environment. The additive under assessment should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. Due to the high concentration of estragole (≥ 1%), the additive is classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of I. verum and its preparations are recognised to flavour food and their function in feed would be the same, no further demonstration of efficacy was necessary., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 leaves and twigs of Eucalyptus globulus Labill. (eucalyptus oil) when used as a sensory additive in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the use of eucalyptus oil is safe at the following concentrations in complete feed: 12 mg/kg for chickens for fattening, 18 mg/kg for laying hens, 16 mg/kg for turkeys for fattening, 22 mg/kg for piglets, 26 mg/kg for pigs for fattening, 32 mg/kg for sows, 55 mg/kg for veal calves (milk replacer), 48 mg/kg for cattle for fattening, sheep, goats and horses, 31 mg/kg for dairy cows, 19 mg/kg for rabbits, 55 mg/kg for salmonids, 58 mg/kg for dogs, 10 mg/kg for cats and 75 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 10 mg/kg complete feed. No concerns for consumers were identified following the use of eucalyptus oil up to the highest safe level in feed. The additive under assessment should be considered as irritant to skin and eyes and the respiratory tract and as a skin sensitiser. The use of eucalyptus oil at the proposed use level in feed was not expected to pose a risk for the environment. Since E. globulus 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of essential oils from the flower buds or the leaves of Syzygium aromaticum (L.) Merr. & L.M. Perry: clove bud oil, clove leaf oil and a β-caryophyllene-rich fraction of clove leaf oil (CCL oil), when used as sensory additives in feed and water for drinking for all animal species. Clove oils contain methyleugenol (up to 0.13%). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove oils was of low concern for long-living and reproductive animals and of no concern for target species for fattening at the following concentrations in complete feed: 25-50 mg/kg for clove bud oil, 28-100 mg/kg for clove leaf oil and 20 mg/kg for CCL oil. The FEEDAP Panel considered that the use in water for drinking alone or in conjunction with use in feed should not exceed the daily amount that is considered of low or no concern when consumed via feed alone. No concerns for consumers were identified following the use of clove oils up to the highest safe level in feed. The additives under assessment should be considered as irritant to skin and eyes and the respiratory tract and as skin sensitisers. When handling the essential oils, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of clove oils at the proposed use level in feed was not expected to pose a risk for the environment. Since clove bud oil and clove leaf oil are recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively. The additives are intended for use with all types of fresh materials and for all animal species at a proposed minimum concentration of 1 × 10 7 colony forming units (CFU) of E. faecium ATCC 53519/kg forage or 5 × 10 6  CFU of E. faecium ATCC 55593/kg forage. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy since the dry matter content of the ensiled materials at the end of the experiments was not corrected for volatiles, which led to an unreliable estimation of the dry matter loss, and the lack of positive effects on any of the other parameters. The supplementary information submitted by the applicant included updated data on the pH values and the dry matter loss corrected for volatiles. However, the estimation of the dry matter loss corrected for volatiles was wrongly calculated and thus, was not considered for the assessment of the efficacy of the additive. Considering the lack of effect on any other fermentation parameter, the Panel could not conclude on the efficacy of the additive to improve the production of silage under the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 herbaceous parts of Pelargonium graveolens L'Hér. (geranium rose oil), when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of geranium rose oil is safe up to the maximum proposed use levels of 5 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers were identified following the use of geranium rose oil up to the maximum proposed use level 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 geranium rose oil at the proposed use level in feed was not expected to pose a risk to the environment. Since P. graveolens 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Calcium carbonate (E 170) was re-evaluated in 2011 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of calcium carbonate (E 170) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and as carry over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators (IBOs) to provide the requested information to complete the risk assessment. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for calcium carbonate and that, in principle, there are no safety concern with respect to the exposure to calcium carbonate per se at the currently reported uses and use levels in all age groups of the population, including infants below 16 weeks of age. With respect to the calcium intake resulting from the use of E 170 in food for the general population and infants < 16 weeks of age, the Panel concluded that it contributes only to a small part to the overall calcium dietary exposure. However, the unavoidable presence of aluminium in E 170 is of concern and should be addressed. In addition, the Panel concluded that the technical data provided by the IBO support further amendments of the specifications for E 170 laid down in Commission Regulation (EU) No 231/2012., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of acetic acid, calcium acetate and sodium diacetate as technological feed additives (preservatives) for salmonids/fish. The additives are already authorised for use for all animal species other than fish. In previous opinions, the FEEDAP Panel concluded that a maximum concentration of 2,500 mg acetic acid/kg complete feed (or 1,000 mg/L water for drinking) was safe for poultry, pigs and pet animals. Ruminants were considered to exhibit a higher tolerance. Due to lack of data for salmonids, the Panel could not conclude on the safety of acetic acid and its salts for fish. The applicant has provided supplementary information consisting in a tolerance study in Atlantic salmon ( Salmo salar ) and a literature search to support the safety of acetic acid in fish. Considering all the available information, the FEEDAP Panel concluded that acetic acid (and its salts by analogy) is considered safe for fish up to the maximum recommended supplementation level of 2,500 mg acetic acid/kg complete feed., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)