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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sepiolite as a technological feed additive for all animal species. In 2022, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of the same additive. The Panel concluded that sepiolite used as a feed additive is safe for the consumers and the environment, and efficacious as a thickener‐suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use. The additive was not considered an eye or skin irritant. However, it was considered a respiratory irritant, a respiratory and dermal sensitiser; owing to the dusting potential and its silica content, the additive was considered a risk by inhalation. Regarding the target species, in the previous Opinion, the Panel concluded on the safety of the additive for dairy ruminants. However, no conclusion could be drawn for all other species/categories. Based on the tolerance studies in chickens for fattening, weaned piglets and trout evaluated in the current assessment, and the one in dairy cows previously assessed, the Panel concluded that the inclusion of sepiolite at the maximum recommended level of 20,000 mg/kg complete feed is safe for all animal species. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of disodium 5′‐inosinate (also known as inosine monophosphate, IMP) produced by Corynebacterium stationis KCCM 80235 as a sensory additive, functional group flavouring compounds, for all animal species. In 2022, the FEEDAP Panel issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers, users and the environment due to uncertainties on the genetic basis of the streptomycin resistance of the production strain C. stationis KCCM 80235 and on the possible presence of its recombinant DNA in the final product. The applicant provided supplementary data which elucidated the genetic basis of the streptomycin resistance of the production strain and excluded the presence of its DNA in the final product. Therefore, the FEEDAP Panel concluded that IMP produced by C. stationis KCCM 80235 is safe for the target species, consumers, users and the environment. The FEEDAP Panel reiterated its previous concerns on the safety for the target species when using IMP in water for drinking due to hygienic reasons. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of lignosulphonate, when used as a technological additive (functional group: binders) in feed for all animal species. In two previous assessments, the FEEDAP Panel concluded that the maximum level proposed of 10,000 mg lignosulphonate/kg complete feed is safe for weaned piglets, pigs for fattening, chickens for fattening, laying hens and cattle for fattening, but a margin of safety could not be identified. Consequently, these conclusions could not be extrapolated to other animal species/categories. In the current application, the applicant proposed to reduce the maximum content of lignosulphonate in feed for all animal species to 8,000 mg/kg complete feed. The results of two newly submitted tolerance studies allowed the Panel to conclude that 8,000 mg lignosulphonate/kg complete feed is also safe for dairy cows and salmonids, with a margin of safety of at least 1.25. Considering the results of the studies previously assessed and those of the two new tolerance studies, the FEEDAP Panel concluded that lignosulphonate is safe for all animal species when used at a maximum content of 8,000 mg/kg complete feed. [ABSTRACT FROM AUTHOR]

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

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of glyceryl polyethyleneglycol ricinoleate (PEG castor oil) as technological feed additive for all animal species. PEG castor oil is safe at a maximum concentration in complete feed of 90 mg/kg for chickens for fattening and other minor growing poultry; 134 mg/kg for laying hens and other laying/breeding birds kept for egg production/reproduction; 121 mg/kg for turkeys for fattening; 162 mg/kg for piglets and other minor growing Suidae; 194 mg/kg for pigs for fattening; 236 mg/kg for sows other minor reproductive Suidae; 231 mg/kg for dairy cows and other dairy ruminants (other than sheep/goats); 142 mg/kg in rabbits and 377 mg/kg in veal calves; 356 mg/kg for cattle for fattening and other growing ruminants, sheep, goat, horses and cats; 427 mg/kg for dogs; 407 mg/kg for salmonids and other fin fish; and 1,584 mg/kg for ornamental fish. For other growing species and non‐food producing animals, the additive is considered safe at 90 mg/kg complete feed. The use of PEG castor oil as feed additive for all animal species would be of no concern for the consumer. The FEEDAP Panel considered inhalation exposure of the user to the additive unlikely. PEG castor oil is not considered a skin sensitiser. The panel was not in the position to conclude on the potential of the additive to be a skin or eye irritant. The additive is a readily biodegradable substance and is not expected to pose a risk for the environment. The lack of sufficient data does not allow the FEEDAP Panel to conclude on the efficacy of PEG castor oil as an emulsifier in feedingstuffs. [ABSTRACT FROM AUTHOR]

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 re‐evaluation of the authorisation of Sepiolitic clay as a feed additive for all animal species. The FEEDAP Panel considered that Sepiolitic clay is unlikely to be absorbed. Harmful amounts of residues of any chemical component in edible tissues/products, as a consequence of the use of Sepiolitic clay as a feed additive, are not expected. Sepiolitic clay is not genotoxic and does not induce any toxicity effects following oral administration and, therefore, it was considered safe for the consumers. Based on the data available, the FEEDAP Panel concluded that Sepiolitic clay is safe for dairy cows and weaned piglets at 20,000 mg/kg feed. These conclusions were extrapolated to other dairy ruminants, pigs for fattening and other growing Suidae. The additive is considered safe for chickens for fattening at 10,000 mg/kg feed and for salmonids at 17,600 mg/kg feed. Considering that it is not possible to establish a comparable margin of safety in the four major species, the Panel cannot conclude on the safety of Sepiolitic clay for other animal species/categories. Owing to the dusting potential of the additive and its crystalline silica content, handling the additive is considered a risk by inhalation for the users. It is not irritant or corrosive to skin or eyes. Due to the nickel content, it is considered a skin and respiratory sensitiser. The additive is considered safe for the environment. The FEEDAP Panel concluded that Sepiolitic clay is efficacious as binder and anticaking agent in feed for all animal species under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of butylated hydroxytoluene (BHT) as a feed additive for all animal species. The additive BHT is considered safe for chickens for fattening and weaned piglets at the maximum proposed concentration of 150 mg/kg complete feed. This conclusion is extended to chickens reared for laying and extrapolated to pigs for fattening. In the absence of data, no conclusion on the safety for the other target species could be drawn. The exposure of the consumer to BHT from tissues and products of animals fed the additive ranged from 1% to 3% of the acceptable daily intake (ADI). The FEEDAP Panel concluded that the use of BHT as a feed additive at the proposed conditions of use is of no concern for the safety of the consumers. Exposure of the user to BHT via inhalation is likely; however, the Panel is not in the position to conclude on the potential inhalation toxicity of the additive. BHT is a skin and eye irritant, no conclusions can be drawn on the potential of the additive to be a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the safety of BHT for the environment. The additive BHT is considered an efficacious antioxidant in feedingstuffs for all animal species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of butylated hydroxytoluene (BHT) as a feed additive for all animal species. The additive BHT is considered safe for chickens for fattening and weaned piglets at the maximum proposed concentration of 150 mg/kg complete feed. This conclusion is extended to chickens reared for laying and extrapolated to pigs for fattening. In the absence of data, no conclusion on the safety for the other target species could be drawn. The exposure of the consumer to BHT from tissues and products of animals fed the additive ranged from 1% to 3% of the acceptable daily intake (ADI). The FEEDAP Panel concluded that the use of BHT as a feed additive at the proposed conditions of use is of no concern for the safety of the consumers. Exposure of the user to BHT via inhalation is likely; however, the Panel is not in the position to conclude on the potential inhalation toxicity of the additive. BHT is a skin and eye irritant, no conclusions can be drawn on the potential of the additive to be a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the safety of BHT for the environment. The additive BHT is considered an efficacious antioxidant in feedingstuffs for all animal species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of guanidinoacetic acid (GAA) when used as nutritional additive in feed and water for drinking for all animal species. The FEEDAP Panel concludes that GAA at 1,200 mg/kg complete feed is safe for chickens for fattening, piglets and pigs for fattening. This concentration in complete feed would correspond to maximum concentrations in water of 600 mg GAA/L for chickens for fattening, piglets and pigs for fattening. The Panel is not in a position to conclude on a safe level of GAA in laying/reproductive birds. In the absence of data on ruminants and salmonids, the FEEDAP Panel cannot conclude on the safety of GAA for all animal species. There is no concern on consumer safety resulting from the use of GAA in feed for poultry and pigs at the proposed conditions of use. The limited data do not allow to conclude on the safety for the consumer when the additive is used in feed for ruminants or fish. GAA is not toxic by inhalation, it is not an irritant to skin and eyes, and it is not a dermal sensitiser. The FEEDAP Panel concludes that the use of GAA as feed additive is not expected to pose a risk to the environment. The use of the additive under assessment in animal nutrition at the proposed conditions of use has the potential to be efficacious in all growing avian, Suidae and ruminant (except for preruminants) species; in growing fin fish other than salmonids and in frog. It is not possible to conclude on the efficacy of the additive in other species, and in reproductive animals. [ABSTRACT FROM AUTHOR]

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 re‐evaluation of the authorisation of sepiolite as a feed additive for all animal species. The FEEDAP Panel considered that sepiolite is unlikely to be absorbed. Harmful amounts of residues of any chemical component in edible tissues/products, as a consequence of the use of sepiolite as a feed additive, are not expected. Sepiolite is not genotoxic and does not induce any toxicity effects following oral administration and, therefore, it was considered safe for the consumers. The additive was considered safe for dairy cows at the recommended use level with a safety factor of 2.5. The conclusion was extrapolated to other dairy ruminants but owing to the lack of sufficient data, no conclusions can be drawn on the safety of the additive for the other target species/categories. Based on the results of a chronic inhalation toxicity study, the additive is considered a respiratory irritant. Owing to the dusting potential of the additive and its silica content, handling the additive was considered a risk by inhalation for the users. It is not irritant or corrosive to skin or eyes. Due to the nickel content, it is considered a skin and respiratory sensitiser. The additive was considered safe for the environment. The FEEDAP Panel concluded that sepiolite was efficacious as a thickener‐suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 potassium diformate for all animal species. The additive was initially evaluated in 2004 and re‐evaluated by the Panel in 2012, with the conclusion that the additive (i) was safe for the target species, the consumer and the environment when used under the proposed conditions; (ii) was an eye irritant and (iii) had the potential to increase the storage time of raw fish and fish by‐products for feed use in a dose‐dependent manner at low temperature. The FEEDAP Panel considered that the use of potassium diformate under the approved conditions of use remains safe for consumers and the environment, and that it is an eye irritant. Due to the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be a skin irritant or a respiratory or dermal sensitiser. Regarding the safety for the target species, the FEEDAP Panel considered that the mixture of different sources of potassium diformate remains safe for use in sows' feed under the approved conditions of use (12,000 mg/kg complete feed). However, based on a tolerance trial, the Panel concluded that the maximum safe level of potassium diformate in weaned piglets should be reduced to 6,000 mg/kg complete feed and the same conclusion was extended to pigs for fattening. Owing to the lack of information provided, the Panel could not conclude on the safety of the additive for species other than pigs under the approved conditions. The present application does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of sodium alginate for all animal species. The additive is intended to be used as a technological additive (functional groups: thickeners and gelling agents). Sodium alginate is intended to be used in feedingstuffs for all animal species at a proposed minimum concentration of 2,000 mg/kg feed and a maximum concentration of to 30,000 mg/kg feed. The data provided for the composition of the additive does not allow a proper assessment of the product consistency, purity and physico‐chemical properties. Sodium alginate is not irritant to skin but should be considered irritant to eyes, a skin and respiratory sensitiser and hazardous by inhalation. Sodium alginate is a high‐molecular‐weight polymer naturally occurring in brown algae. The use of sodium alginate in animal nutrition is considered safe for the consumers and the environment. No conclusion could be drawn on the safety of sodium alginate for the target species or on its efficacy as a thickener or gelling agent in feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5'‐inosinate (IMP) produced by fermentation using Corynebacterium stationis KCCM 80235 as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is genetically modified, and it is resistant to streptomycin. No viable cells were detected in the final product. However, uncertainties remained on the genetic basis of the streptomycin resistance and on the possible presence of recombinant DNA from the production strain in the final product. Therefore, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for the target species, consumers, users and the environment. Moreover, the FEEDAP Panel reiterated its previous concerns on the safety of the use of IMP in water for drinking due to hygienic reasons. The Panel concluded that the additive is efficacious to contribute to the flavour of feed and water for drinking. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5'-guanylate produced by fermentation with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The additive does not raise safety concerns under the proposed conditions of use for the target species, consumers the users and the environment. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) expressed reservations on the use of the additive in water for drinking due to concerns on its impact on hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed. [ABSTRACT FROM AUTHOR]

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 phyllite, a natural mixture of minerals of metamorphic origin, as a feed additive for all animal species. The additive, specified to contain at least 40% of mica, muscovite, illite, chlorite and talc as the main components, and maximum 60% of quartz, potassium-feldspar, sodium-feldspar and calcite, is intended for use as a technological additive (functional groups: (i) anticaking agents) in premixtures and feedingstuffs for all animal species at a maximum inclusion level of 25,000 mg/kg. The additive is safe for chickens for fattening and chickens reared for laying/breeding at the maximum inclusion level of 25,000 mg/kg feed, with no margin of safety determined. Owing the absence of data in pigs and ruminants and in the absence of data on the potential genotoxicity of the additive, the Panel is not in the position to conclude on the safety of the additive for any other animal species/categories. The additive is considered safe for the consumers and the environment at the proposed conditions of use. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant and skin sensitiser. Exposure via inhalation is considered a risk. The FEEDAP Panel is not in the position to conclude on the efficacy of the additive as an anticaking agent. [ABSTRACT FROM AUTHOR]

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 hydroxypropyl cellulose as a feed additive for all animal species. Hydroxypropyl cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser and thickener) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of hydroxypropyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to hydroxypropyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that hydroxypropyl cellulose is considered safe for all animal species. The use of hydroxypropyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of hydroxypropyl cellulose for the user. The use of hydroxypropyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species. [ABSTRACT FROM AUTHOR]

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 methyl cellulose as a feed additive for all animal species. Methyl cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser, thickener, gelling agent and binder) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of methyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to methyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that methyl cellulose is considered safe for all animal species. The use of methyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of methyl cellulose for the user. The use of methyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species. [ABSTRACT FROM AUTHOR]

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 sodium carboxymethyl cellulose as a feed additive for all animal species. Sodium carboxymethyl cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser, thickener, gelling agent and binder) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of sodium carboxymethyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to sodium carboxymethyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that sodium carboxymethyl cellulose is considered safe for all animal species. The use of sodium carboxymethyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of sodium carboxymethyl cellulose for the user. The use of sodium carboxymethyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Pediococcus pentosaceus DSM 16244 as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but considered a skin and respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

The additive lignosulphonate of magnesium is intended to be used as a technological additive (functional group: binders) for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the absence and/or incompleteness of information needed in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the format requirements of the application and the structure of the dossier. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive lignosulphonate of magnesium as a technological additive for all animal species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of propyl gallate as feed additive for all animal species. Propyl gallate is neither genotoxic nor carcinogenic. Propyl gallate a is safe for veal calves, cattle for fattening, dairy cows, sheep, goats, sows, horses and salmonids at the proposed maximum use level of 40 mg/kg and for ornamental fish at the proposed maximum use level of 100 mg/kg. The following concentrations (mg/kg complete feed) are considered safe for the other target species: 15 for chickens for fattening; 20 for turkeys for fattening, laying hens and rabbits; 27 for piglets and pigs for fattening and 71 for dogs. The Panel cannot conclude on a safe level for cats. The exposure of the consumer to propyl gallate and its metabolites cannot be estimated owing to the absence of reliable data on residues of propyl gallate and its metabolites in edible tissues and products. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for the consumer of propyl gallate, when used as a feed additive for all food‐producing animal species. Propyl gallate is irritant to skin and eyes and a dermal sensitiser. Exposure via inhalation is possible and it is considered a hazard. The use of the additive in animal nutrition does not pose a risk for the environment. The FEEDAP Panel concludes that propyl gallate has the potential to act as an antioxidant in feedingstuffs. The Panel did not see a reason for the use of propyl gallate as an antioxidant in water for drinking. [ABSTRACT FROM AUTHOR]

The additive Shellac is intended to be used as a technological additive (functional group: stabiliser) for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the description of the additive/efficacy, and safety of the additive. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the request from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive Shellac as a technological additive for all animal species. [ABSTRACT FROM AUTHOR]

The additive UD60 (phosphoric acid 60% on silica carrier) is intended to be used as a technological additive (functional group: preservative) for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the characterisation, the safety for the target species and the efficacy of the additive. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive UD60 (phosphoric acid 60% on silica carrier) as a technological additive for all animal species. [ABSTRACT FROM AUTHOR]

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 a preparation of algae interspaced bentonite when used as aflatoxin B1 binder for all animal species. The additive is composed of bentonite and algae belonging to Ulva spp. The additive is considered safe for weaned piglets, dairy cows and chickens for fattening at the maximum recommended dose of 125 mg/kg complete feed (a wide margin of safety is established in weaned piglets and dairy cows); this conclusion is extrapolated to all animal species. The additive is not genotoxic. As bentonite is essentially not absorbed from the gut lumen and algae from Ulva spp. are not expected to be of concern for human consumption, the FEEDAP Panel considers that the use of the additive in animal nutrition is safe for consumers. The additive is not an irritant to the skin or the eyes and it is considered to have low inhalation toxicity. However, the additive has a high dusting potential and contains a high proportion of fine particles. A high level of inhalation exposure to an inert dust may be hazardous. In the absence of data, the Panel could not conclude on dermal sensitisation. As the components of the additive are of natural origin (soil and marine environment), it is not expected that the use of the additive in animal nutrition would adversely affect the environment. The FEEDAP Panel could not conclude on the efficacy of the additive for all animal species. [ABSTRACT FROM AUTHOR]

l-Tryptophan is a feed additive produced by fermentation using a genetically modified strain of Escherichia coli. The EFSA Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP Panel) issued an opinion on the safety and efficacy of the product, which concluded that 'The use of l-tryptophan produced by E. coli CGMCC 7.59 in feed is safe for non-ruminant target species when supplemented to diets in appropriate amounts. As the metabolites of l-tryptophan produced by ruminal bacteria may be toxic to the host animal, oral administration of unprotected l-tryptophan to ruminants should be avoided. The Panel on Additives and Products or substances used in Animal Feed ( FEEDAP) has concerns about the safety of l-tryptophan for target species when administered via water for drinking... ...In the absence of any data on sensitisation, the product should be considered a potential dermal sensitiser. The level of endotoxins present in the product and its dusting potential indicate a health risk for the user upon inhalation'. The European Commission asked EFSA to deliver an opinion on the safety of l-tryptophan, produced by an improved manufacturing process, as a nutritional additive for all animal species based on additional data submitted by the applicant on characterisation of the additive. The FEEDAP Panel reiterates its concern on the use of unprotected tryptophan to ruminants and on the safety of the amino acid l-tryptophan for target species when administered simultaneously via water for drinking. As the estimated maximum exposure to endotoxins by inhalation of the improved product is below the provisional occupational exposure limit, no risk from exposure to endotoxins for people handling the additive is expected. Concerns remain about possible dermal sensitisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of benzoic acid as a feed additive for pigs for fattening when used as a technological additive (acidity regulator) and for all animal species when used as a sensory additive (flavouring). The FEEDAP Panel reiterates its former conclusion that the use of benzoic acid at the maximum level of 125 mg/kg complete feed is safe for all animal species, but cannot conclude on the safety of benzoic for pigs for fattening at the proposed maximum use level (10,000 mg benzoic acid/kg complete feed). The FEEDAP Panel concludes that the use of benzoic acid as a feed additive at the proposed conditions of use is safe for the consumer. Benzoic acid is an irritant to skin and eyes, is not a skin sensitiser and may pose a risk to the users by inhalation. The use of benzoic acid in animal nutrition will not pose a risk for the environment. Since benzoic acid is authorised in food as flavouring and its function in feed is essentially the same as that in food, no further demonstration of efficacy of benzoic acid as flavouring is necessary. In the absence of data, the FEEDAP Panel is not in the position to conclude on the efficacy of benzoic acid when used as acidity regulator in feed. [ABSTRACT FROM AUTHOR]

This opinion concerns the re-authorisation of lactic acid and calcium lactate for use as preservatives in feed and a new authorisation for lactic acid as a preservative in water for drinking. The maximum level of 50 000 mg lactic acid/kg complete feed and 30 000 mg calcium lactate/kg complete feed are considered safe for functional ruminants and pigs. The maximum safe concentration in water for drinking for pigs can be derived from the maximum safe level in feed (15 000 mg lactic acid/L water). No conclusions on the safety of lactic acid in pre-ruminants and poultry can be drawn. These conclusions cannot be extrapolated to other animal species/categories. The use of lactic acid and calcium lactate as feed additives is safe for the consumer. Lactic acid is considered an irritant to eyes and skin and there is a risk of serious damage to the eyes. Inhalation of the mist causes irritation of the respiratory system. Calcium lactate should be considered an irritant to skin, eyes and the respiratory tract. It is likely that handling the additive will result in the production of respirable dust, which could present a risk to unprotected workers. The use of lactic acid and calcium lactate in animal nutrition would not pose a risk to the environment, provided that the concentrations regarded as safe for the target species are not exceeded. Lactic acid and calcium lactate are used in food as preservatives. It is reasonable to expect that the effect seen in food will be observed in feed when these additives are used at comparable concentrations and under similar conditions. However, the Panel has reservations about the effectiveness of lactic acid and calcium lactate as preservatives in complete feedingstuffs with a typical moisture content of ≤ 12 %. [ABSTRACT FROM AUTHOR]

The additive complexation products of sodium tartrates with iron(III) chloride (Fe-TA), which is a an equilibrium mixture of sodium tartrates with iron(III) chloride, is intended to be used as an anticaking agent in salt (sodium chloride) for all animal species and categories. The proposed inclusion levels vary between 3 and 12 mg iron/kg salt, equivalent to 26 to 106 mg Fe-TA/kg salt (on a dry matter basis). Fe-TA is intended to be dripped onto salt in the form of a 1:8 water solution. The use of Fe-TA at the maximum recommended supplementation rate for common salt (106 mg Fe-TA dry matter/kg) is considered safe for all animal species and categories. There is no indication that the use of Fe-TA in animal nutrition would result in a measurable exposure of the consumer to Fe-TA or its constituents tartrate, iron and oxalate. Therefore, no concerns for the safety for the consumer would arise from the use of Fe-TA, provided that the conditions of use recommended by the applicant are respected. Users are unlikely to be exposed to the additive by inhalation. Fe-TA is not an irritant to skin and eyes, is not a skin sensitiser and is of low acute dermal toxicity. No risk to the environment is expected from the use of Fe-TA in animal nutrition. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive has the potential to be efficacious as an anticaking agent when used in salt at the minimum proposed concentration of 3 mg iron/kg salt (equivalent to 26 mg Fe-TA/kg salt, on a dry matter basis). [ABSTRACT FROM AUTHOR]

L-Tryptophan, technically pure, is a feed additive produced by a genetically modified Escherichia coli strain (CGMCC 7.59). The additive does not give rise to safety concerns regarding the genetic modifications of the production strain. The use of L-Tryptophan produced by E. coli CGMCC 7.59 in feed is safe for non-ruminant target species when supplemented to diets in appropriate amounts. As the metabolites of L-Tryptophan produced by ruminal bacteria may be toxic to the host animal, oral administration of unprotected L-Tryptophan to ruminants should be avoided. The Panel on Additives and Products or substances used in Animal Feed (FEEDAP) has concerns about the safety of L-Tryptophan for target species when administered via water for drinking. The composition of edible tissues and products of animal origin will not be changed by the use of the product L-Tryptophan in animal nutrition when supplemented in appropriate amounts. No risks are expected for the consumer from the use of L-Tryptophan, produced by E. coli CGMCC 7.59 as a feed additive, considering the purity of the additive (≥ 99.1 % L-Tryptophan) and the low levels of 1,1′-ethylidene-bis-L-Tryptophan (EBT) and 1-methyl-1,2,3,4-tetrahydro-beta-carboline-3-carboxylic acid (MTCA) (< 10 mg/kg additive each). The product L-Tryptophan, technically pure, is considered to be non-irritant to skin and eyes. In the absence of any data on sensitisation, the product should be considered a potential dermal sensitiser. The level of endotoxins present in the product and its dusting potential indicate a health risk for the user upon inhalation. The product under assessment does not pose any risk to the environment when supplemented to feed. The product L-Tryptophan is regarded as an effective source of the amino acid L-Tryptophan for all non-ruminant species. For the supplemental L-Tryptophan to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

An application has been made for the re-authorisation of citric acid (anhydrous and monohydrate) when used as a preservative in feed and also for the new use in water for drinking for all animal species. Citric acid (anhydrous and monohydrate) is already authorised for use in food and feed as a preservative following the quantum satis principle. There is evidence from published studies that citric acid is safe for the target species when used up to 30 000 mg citric acid/kg complete feedingstuffs and the corresponding concentration in water for drinking (10 000 mg citric acid/L). The additive is, consequently, also safe for the target species at the proposed conditions of use of 15 000 mg citric acid/kg complete feedingstuffs and 5 000 mg citric acid/L in water for drinking. The quality of available data does not allow a margin of safety to be derived. The use of citric acid in animal nutrition is safe for the consumer. It is prudent to regard citric acid as potentially hazardous to workers by exposure of the skin, eyes or mucous membranes or by inhalation. The use of citric acid in animal nutrition would not pose a risk to the environment. Although citric acid is a well-recognised preservative in food, based on data provided the effectiveness of citric acid as a preservative in feedingstuffs and water for drinking was not sufficiently demonstrated. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has reservations about the effectiveness of organic acids as preservatives in feedingstuffs with a typical moisture content of ≤ 12 %. [ABSTRACT FROM AUTHOR]

An application has been made for the authorisation of citric acid (anhydrous and monohydrate) when used as an acidity regulator in feed and in water for drinking for all animal species. Citric acid (anhydrous and monohydrate) is already authorised for use in food following the quantum satis principle. There is evidence from published studies that citric acid is safe for the target species when used up to 30 000 mg citric acid/kg complete feedingstuffs and the corresponding concentration in water for drinking (10 000 mg citric acid/L). The additive is consequently also safe for the target species at the proposed conditions of use of 15 000 mg citric acid/kg complete feedingstuffs and 5 000 mg citric acid/L in water for drinking. The quality of the available data does not allow a margin of safety to be derived. The use of citric acid in animal nutrition is safe for the consumer. It is prudent to regard citric acid as potentially hazardous to workers by exposure of the skin, eyes or mucous membranes or by inhalation. The use of citric acid in animal nutrition would not pose a risk for the environment. The addition of citric acid reduces the pH of aqueous suspensions of compound feedingstuffs and feed materials. However, the relevance of pH and buffer capacity measurements made with aqueous suspensions to the effects of citric acid in dry feed (< 12 % moisture) is open to question. Citric acid might have the potential to act as an acidity regulator in feedingstuffs. [ABSTRACT FROM AUTHOR]

This opinion concerns the re-evaluation of calcium formate for use as a preservative in feed for all animal species and categories. Calcium formate is currently authorised for use as a preservative in feed for all animal species, but is not authorised as a food additive in the EU. Considering the results of the tolerance studies with chickens for fattening and cattle for fattening, and other published studies, no adverse effects on target animals safety are anticipated when calcium formate is used at the maximum proposed dose in feed for pigs, poultry, fish and ruminants (15 000 mg calcium formate/kg complete feed, equivalent to 10 000 mg formic acid/kg complete feed). However, no margin of safety can be established. This conclusion can be extrapolated to other animal species provided the maximum dose applied does not exceed 15 000 mg calcium formate/kg complete feed. The contribution of calcium formate to the calcium supply of animals should be considered when formulating diets. Considering that the turnover of formate is rapid, with no evidence of accumulation in body tissues, neither calcium nor formate concentrations will increase in the edible tissues of animals maintained on feed with calcium formate added and, therefore, the use of calcium formate as a feed additive in all animal species is considered safe for the consumer. Calcium formate is non-irritant to skin but causes severe adverse effects in eyes. It is likely that handling the additive could result in skin reactions and in the production of respirable dust that could present a risk to unprotected workers. The use of calcium formate in animal nutrition is safe for the environment. Data submitted do not provide convincing evidence of the efficacy of the additive when used as a preservative for compound feed or feed materials. [ABSTRACT FROM AUTHOR]

This opinion concerns the re-authorisation of formic acid for use as a preservative in feed and water for drinking and as a silage additive in feed for all animal species and categories. No adverse effects are to be anticipated when formic acid is used at the maximum proposed dose in feed for pigs (12 000 mg formic acid/kg complete feed), poultry or ruminants (10 000 mg formic acid/kg complete feed). A margin of safety could not be identified. These conclusions are extrapolated to other animal species at a maximum dose of 10 000 mg formic acid/kg complete feed. Considering that the turnover of formic acid is rapid, with no evidence of accumulation in body tissues, its use in animal nutrition is not expected to contribute to consumer exposure. Therefore, the use of formic acid as a feed additive in all animal species is considered safe for the consumer. Formic acid at concentrations greater than 10 % is considered to be corrosive to skin and eyes. The acid is volatile, and exposure via inhalation for those handling the additive, as well as exposure to skin and eyes, is considered to present a risk to unprotected workers. The FEEDAP Panel considers that the use of formic acid in animal nutrition is safe for the environment. Formic acid at the recommended concentrations inhibits bacterial growth in feedingstuffs and water for drinking, and is recognised as an efficacious silage additive. [ABSTRACT FROM AUTHOR]

The l‐threonine under assessment is produced by fermentation with a genetically modified strain of Escherichia coli and it is intended to be used as a nutritional additive for all animal species. In 2017 the Panel on Additives and products or Substances used in Animal Feed (FEEDAP) of EFSA issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers and the environment due to the lack of data regarding the characterisation of the production strain and the resulting product. The applicant provided additional data on the identity of the production strain, the genetic modification, the susceptibility to antibiotics and the absence of cells and recombinant DNA of the production strain in the final product. The recipient strain is safe and the genetic modification does not raise concerns. Moreover, viable cells or DNA of the production strain were not detected in the final product. With this new information the FEEDAP Panel concluded that l‐threonine produced by E. coli CGMCC 11473 is safe for the all animal species, the consumers and the environment. The FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or on the skin sensitisation potential. It was concluded that there is a risk of exposure to endotoxins by inhalation for persons handling the additive. [ABSTRACT FROM AUTHOR]