Assessment of the feed additive consisting of inositol (3a900) for fish and crustaceans for the renewal of its authorisation (Zhucheng Haotian Pharm Co., Ltd.)

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of ascorbic acid, sodium ascorbate, calcium ascorbate, ascorbyl palmitate, sodium calcium ascorbyl phosphate, sodium ascorbyl phosphate (as sources of vitamin C) as feed additives for all animal species. The applicants have provided data demonstrating that the additives currently in the market comply with the conditions of authorisation. Thus, the FEEDAP Panel concludes that the additives remain safe for the target species, consumers and the environment. Regarding the user safety, ascorbic acid and sodium ascorbyl phosphate are not irritant to the skin or eyes and are not dermal sensitisers. Sodium ascorbate is not a skin sensitiser, but the Panel cannot conclude on its potential to be irritant to skin and eyes. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety of calcium ascorbate for the user. Ascorbyl palmitate is not irritant to skin and eyes and is not a dermal sensitiser. Sodium calcium ascorbyl phosphate should not be considered a skin and eye irritant nor a skin sensitiser.There is no need to assess the efficacy of the additives in the context of the renewal of the authorisation.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion (safety and efficacy) on the application for the renewal of the authorisation of l‐carnitine (3a910) and l‐carnitine l‐tartrate (3a911) as nutritional feed additives. The additives are currently authorised for use in all animal species. The applicant has provided evidence that the additives currently in the market comply with the existing conditions of authorisation. Two examples of l‐carnitine preparations currently placed on the market are described in the application. There is no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions. Thus, the FEEDAP Panel concluded that the additives remain safe for the target species, consumers and the environment. Regarding user safety, the additives are not irritants to skin and eyes nor skin sensitisers. In the absence of data on the different preparations, the FEEDAP Panel could not conclude on the safety for the user of any preparations containing l‐carnitine. There is no need to assess the efficacy of the additives in the context of the renewal of the authorisation.

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 zinc chloride hydroxide monohydrate as a nutritional feed additive for all animal species (3b609). The applicant reported changes in the production process and requested a change in the specification of the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) confirms that the use of the additive under the current authorised conditions of use is safe for the target species and the consumers. The use of the additive in animal nutrition at the proposed use levels for the terrestrial species and land-based aquaculture systems is considered safe for the environment. The FEEDAP Panel cannot conclude on the safety of the additive for marine sediment compartment, when it is used in sea cages. The additive is an eye irritant, but not irritant to the skin and not a skin sensitiser. The exposure through inhalation is likely, but in the absence of data, the Panel is not in a position to conclude on the risk of exposure by inhalation. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of beta-carotene (3a160(a)) for the renewal of its authorisation as a nutritional additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of beta-carotene in animal nutrition under the approved conditions remains safe for target species, consumers and the environment. Regarding user safety, the FEEDAP Panel concludes that beta-carotene is not a skin and eye irritant and not a skin sensitiser. One preparation containing 10% beta-carotene was shown not to be a skin sensitiser. However, no conclusions on the safety for the user can be done on any other preparations. The Panel concluded there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of chromium chelate of dl‐methionine (Availa® Cr) for all finfish. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for salmonids at the maximum proposed use level of 600 mg additive/kg complete feed (corresponding to 0.6 mg Cr/kg complete feed). The FEEDAP Panel was not in the position to conclude on the safety of the use of Availa® Cr in feed for other finfish. The use of the additive in finfish feed at the maximum proposed use level was considered safe for the consumer and for the environment. Regarding user safety, the FEEDAP Panel concluded that the additive is not an eye nor skin irritant, but due to the presence of nickel, the additive is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel concluded that the additive has the potential to be efficacious in salmonids at 0.2 mg Cr/kg complete feed, and in other finfish at 0.5 mg Cr/kg complete feed.

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

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

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper bilysinate as nutritional feed additive for all species and categories. The additive is currently authorised for use in all animal species (3b411). The applicant has provided evidence that the additive, in powder or granule forms, complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of copper bilysinate under the current authorised conditions of use is safe for the target species, consumers and the environment. Regarding user safety, both forms of the additive are not irritant to the skin, but the powder product is an eye irritant. Both forms of the additive should be considered skin and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of 6‐phytase produced with a genetically modified strain of Trichoderma reesei (CBS 126897) (Quantum® Blue) as a zootechnical feed additive for poultry, piglets, pigs for fattening and sows, other porcine species and ornamental birds. The additive is currently authorised for use in feed for laying birds, poultry other than laying birds, weaned piglets, pigs for fattening and sows. This scientific opinion concerns the request for the renewal of the authorisation of the additive for these species and the extension of use to suckling piglets and other porcine species and ornamental birds. The additive is available in two solid (Quantum® Blue 5 G and 40 P) and two liquid formulations (Quantum® Blue 5 and 10 L). Some changes in the composition of the product have been implemented since the first authorisation. The applicant provided evidence that the additive complies with the terms of the authorisation. The FEEDAP Panel concluded that all formulations of the additive remain safe for the target species, consumers and the environment, and that the extension of use to the new species would not affect these conclusions. Regarding user safety, all the forms of the additive should be considered as respiratory sensitisers. The solid forms of the additive are dust free; therefore, the exposure of users through inhalation is unlikely. No specific information was submitted for the four formulations of the additive under assessment regarding their potential to be skin and eye irritants and skin sensitisers. In the absence of data, the FEEDAP Panel is not in the position to conclude on the potential of the additive to be skin and eye irritants or skin sensitisers. There is no need for the assessment of efficacy in poultry, weaned piglets, pigs for fattening and sows in the context of the renewal of the authorisation. The FEEDAP Panel considers that the additive has the potential to be efficacious in ornamental birds at 250 FTU/kg complete feed and in suckling piglets and in suckling and weaned piglets of minor porcine species at 500 FTU/kg and in minor porcine species for fattening/reared for reproduction and reproductive animals at 250 FTU/kg complete feed.

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 choline chloride as a nutritional additive for all animal species. The additive is already authorised for use in all animal species (3a890). The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the feed additive in animal nutrition under the proposed conditions of use remains safe for the target species, the consumers and the environment. Regarding user safety, the FEEDAP Panel concluded that the active substance choline chloride should be considered as a potential skin and respiratory sensitiser; therefore, any exposure via skin or respiratory tract is considered a risk. Although aqueous solutions of up to 70% choline chloride are considered non‐irritant to eyes, no conclusion can be reached on the eye irritation potential for more concentrated forms. These conclusions would apply, in principle, to any preparations produced with the active substance. The present application for renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and therefore there is no need for re‐assessing the efficacy.

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 dried extracts prepared from the dried roots of Echinacea angustifoliaDC. or the dried aerial parts of Echinacea purpurea (L.) Moench, when used as sensory feed additives for cats and dogs. E. angustifolia extract is specified to contain at least 4% echinacosides and E. purpurea extract at least 4% total phenols. Since about 75% of the composition of the extracts remained uncharacterised, the FEEDAP Panel was unable to conclude on the safety for the target species. In the absence of data, no conclusions can be drawn on the potential of the extracts to be dermal/eye irritants or skin sensitisers. In the absence of evidence that the extracts act as flavours in animal feed or have an effect on palatability, the FEEDAP Panel was unable to conclude on the efficacy of the additives.

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 Lactiplantibacillus plantarum NCIMB 40027 as a technological additive (functional group: silage additives) for use in fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers, and the environment. Regarding user safety, the FEEDAP Panel reiterates its previous conclusion that the additive is not irritant to skin or eyes. However, it should be considered as a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

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 fresh or dried flowering stems of Salvia sclarea L. (clary sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for veal calves (milk replacers), cattle for fattening, sheep/goats, 10 mg/kg for horses, 20 mg/kg for dogs, salmonids and ornamental fish. For the other target species, the calculated safe concentrations were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 9 mg/kg for piglets, 11 mg/kg for pigs for fattening, 14 mg/kg for sows, 13 mg/kg for dairy cows, 8 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 4 mg/kg complete feed. The FEEDAP Panel considered that the use level in water of clary sage oil is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of clary sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering stems of S. sclarea is 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.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of monensin sodium (Coxidin®) produced with Streptomyces sp. LMG S‐19095 as a coccidiostat for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. In 2024, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for chickens for fattening and chickens reared for laying, nor on the potential of the formulation containing calcium carbonate to be irritant to skin and eyes and to be a skin sensitiser, and could not exclude a risk for the aquatic compartment when used in chickens for fattening. The applicant provided additional information to address the limitations regarding the safety of the additive and submitted a plan for the post marketing monitoring. During the assessment the applicant reduced the maximum recommended dose for the use of the additive in chickens for fattening and chickens reared for laying from 125 to 120 mg monensin sodium/kg complete feed. The Panel concludes that the use of monensin sodium from Coxidin® is safe up to the newly proposed maximum recommended level of 120 mg/kg complete feed for chickens for fattening and chickens reared for laying/breeding. Coxidin® formulated with calcium carbonate is not a skin irritant but should be considered as a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. No conclusions can be reached on its eye irritation potential. The use of monensin sodium from Coxidin® in complete feed for chickens for fattening and chickens reared for laying poses no risk for the environment. The proposal of the post‐market monitoring plan of the applicant is appropriate.