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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 copper(II)-betaine complex as nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chicken, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of copper in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum copper levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the copper(II)-betaine complex in animal nutrition at the maximum copper levels authorised for the animal species poses no concern to the safety of consumers. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land-based aquaculture is considered safe under proposed conditions of use. The data available do not allow the conclusion to be made on the safety of the additive for marine sediment when it is used in sea cages. 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. The Panel could not conclude on the efficacy of the product.

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

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a zinc(II)–betaine complex as nutritional additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion could be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded. The FEEDAP Panel concluded that the use of the zinc(II)–betaine complex in animal nutrition is of no concern for consumer safety provided that the maximum authorised total zinc levels in feed are respected. The additive is considered to be a skin and respiratory sensitiser due to the presence of nickel; it is irritant to the eyes, but not to the skin. The use of the additive in animal nutrition for terrestrial animals and land-based aquaculture at the proposed use levels is considered safe for terrestrial and aquatic ecosystems. The available data do not allow the conclusion to be made on the safety of the additive for the marine sediment when it is used in sea cages. Based on the deposition of zinc in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable zinc, comparable to the standard inorganic zinc source, and therefore, the additive is efficacious in meeting the birds zinc requirements. This conclusion can be extrapolated to all animal species and categories.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO® ADVANCE (liquid and solid) which contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The enzymes present in the additive are produced by two strains of Talaromyces versatilis, one of them genetically modified. The additive is intended to be used as a feed additive for weaned piglets and pigs for fattening. Viable cells of the production strains and DNA of the genetically modified strain were not detected in the fermentation product used to formulate the additive. Based on the results of a tolerance trial in weaned piglets, the FEEDAP Panel concluded that ROVABIO® ADVANCE is safe for weaned piglets under the recommended conditions of use. This conclusion was extended to pigs for fattening. Based on the outcome of the toxicological studies performed, the Panel concluded that the additive is of no concern regarding consumer safety. ROVABIO® ADVANCE is not irritant to the skin or eyes but it is a skin and respiratory sensitiser. No risks to the environment are expected from the use of the additive in animal nutrition. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of ROVABIO® ADVANCE.

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Bifidobacterium longum CNCM I-5642 (PP102I) when used as a feed additive for cats and dogs. The product under assessment consists of viable cells of a strain of B. longum, a species considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The strain was unambiguously identified as B. longum and was shown not to harbour antimicrobial resistance determinants for antibiotics of human and veterinary importance, thus meeting the QPS requirements. Following the QPS approach to safety assessment and since no concerns are expected from maltodextrin, the other component of the additive, PP102I was considered safe for the target species and the environment. Owing to the lack of data, no conclusions could be drawn on the skin/eye irritancy potential of PP102I. However, it should be considered a skin and respiratory sensitiser. The Panelwas not in the position to conclude on the efficacy of PP102I for the target species.

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 HOSTAZYM® X as a feed additive for sows in order to have benefits in piglets. This additive consists of endo-1,4-β-xylanase produced by a non-genetically modified strain of Trichoderma citroviride. The additive is to be used in sows at 1,500 EPU/kg feed. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. The applicant provided new efficacy data to complete the assessment of the efficacy of the additive. Based on the previously assessed data and the newly submitted one, the Panel could not conclude on the efficacy of the additive.

Following a request from the European Commission, the FEEDAP Panel was asked to deliver a scientific opinion on the safety and efficacy of l-methionine ≥ 98.5% or ≥ 90% produced by the combined activities of Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246) as nutritional additive for all animal species. The two production strains are genetically modified. l-Methionine is intended to be used in feed or water for drinking for all animal species. Neither viable cells nor recombinant DNA of the production strains were detected in the final products. The additive does not pose any safety concern associated with the genetic modification of the production strains. The use of both products of l-methionine produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 in supplementing feed to compensate for l-methionine deficiency in feedingstuffs is safe for the target species. The FEEDAP Panel has concerns about the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of both products of l-methionine produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 in animal nutrition is considered safe for the consumers and for the environment. The additive, in either product, is not an irritant to skin/eyes and not a dermal sensitiser and shows no toxicity by inhalation. Considering the respiratory exposure to endotoxins, l-methionine ≥ 90% is a risk for the user. Both products of the additive produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 are considered as an efficacious source of the essential amino acid l-methionine for non-ruminant animal species. For the supplemental l-methionine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

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 l-glutamic acid and monosodium l-glutamate monohydrate produced by fermentation using the genetically modified strain Corynebacterium glutamicum NITE BP-01681. The additives are intended to be used in feed and water for drinking for all animal species and categories as nutritional additives (amino acids) or as sensory additives (flavouring compounds). Viable cells of the production strain and its DNA were not detected in the final additives. The additives do not give rise to any safety concern regarding the production strain. l-Glutamic acid and monosodium l-glutamate monohydrate produced using C. glutamicum NITE BP-01681 are considered safe for the target species, for the consumer and for the environment. However, the Panel raised concerns on the use in water for drinking for hygienic reasons. The additives are considered not irritant to skin or eyes and not dermal sensitisers but a risk by inhalation. The Panel concluded that the additives are efficacious as nutritional additives and as flavouring compounds.

Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non-irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser.

Following a request from the European Commission, the FEEDAP Panel was asked to deliver a scientific opinion on the safety and efficacy of astaxanthin (ATX)-rich Phaffia rhodozyma. The additive, belonging to the category ‘sensory additives’ and the functional group ‘substances which, when fed to animals, add colours to food of animal origin’ is intended to be used in feed for salmon and trout from an age of six months onwards up to a maximum content of 100 mg ATX/kg complete feed. The product is produced by the telemorph of Phaffia rhodozyma, Xanthophyllomyces dendrorhous, and it is declared to contain 995 g dried inactivated biomass and 5 g ascorbic acid per kg additive. The main active principle of the additive is ATX; however, the FEEDAP Panel noted that some other carotenoids are also present in lower quantities. The minimum ATX concentration is specified to be 5,000 mg per kg additive. The yeast Xanthophyllomyces dendrorhous is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment; therefore, the use of the production strain in the production of the additive would not raise any safety concern for the target species, the consumers of products from animals fed the additive and the environment. In the absence of a tolerance study with the additive, the FEEDAP Panel cannot conclude on the safety for the target species. In the absence of residue and toxicity data of ATX, no final conclusions on the safety for the consumer can be drawn. The FEEDAP Panel concluded that the additive is irritant to skin and eyes, and a skin and respiratory sensitiser, although exposure by inhalation is likely low. The FEEDAP Panel considers that ATX from the biomass does not pose a significant additional risk to the environment compared with other natural sources of ATX. In absence of adequate evidence, no conclusion can be made on the efficacy of the additive.

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 Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 as a technological additive for use in forage for all animal species. The additive aims at improving the production of silage and is authorised 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 to 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 L. buchneri DSM 12856 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. 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, 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 BA-KING® Bacillus velezensis when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non-food producing species. The product under assessment is based on viable spores of a strain identified as B. velezensis, which is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NITE BP-01844 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, BA-KING® is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. BA-KING® is not irritant to skin but is potentially irritant to eyes. In addition, should be considered a skin and respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of BA-KING® for the target species.

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 an additive consisting of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species P. freudenreichii and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to assessment. As the identity of the strains has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strains as a silage additive is considered safe for livestock species, for consumers and for the environment. The additive is not irritant for eyes or skin but should be considered a respiratory sensitiser. In the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be a skin sensitiser. The additive at the proposed application rate of 1 × 108 CFU/kg fresh plant material showed the potential to improve the aerobic stability silage with dry matter content ranging from 30% to 70%.

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

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.

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.

Ethoxyquin is synthetised from p-phenetidine, a possible mutagen, which remains in the additive as an impurity at concentrations of < 2.5 mg/kg additive. Ethoxyquin is considered safe for all animal species at the proposed inclusion level of 50 mg/kg complete feed. However, owing the presence of p-phenetidine, no safe level of the additive in feed for long-living and reproductive animals could be identified. The FEEDAP Panel derived a health-based guidance value of 0.006 mg ethoxyquin dimer (EQDM)/kg bw per day and applied it to the sum of ethoxyquin and its transformation products. A maximum total concentration of 50 mg ethoxyquin/kg complete feed for all animal species, except dairy ruminants, would not pose a risk for the consumer. However, in the absence of data on p-phenetidine residues in tissues and products of animal origin, no conclusion on the safety for the consumer could be drawn. The conclusions on consumer safety assume that the maximum total concentration of 50 mg EQ/kg feed is expressed as the sum of EQ, EQDM, EQI and DHEQ. Exposure of the unprotected user to p-phenetidine via inhalation should be minimised. No safety concerns for groundwater are expected. It is not possible to conclude on the safety of EQ for the terrestrial compartment. A risk for the aquatic compartment cannot be excluded when ethoxyquin is used in terrestrial animals. Unacceptable risk is not expected for freshwater sediment-dwelling organisms. A risk of secondary poisoning via the terrestrial food chain is not expected, whereas a risk via the aquatic food chain cannot be excluded. No concerns for aquatic organisms are expected for ethoxyquin used in fish farmed in land-based system, a risk cannot be excluded for marine sediment dwelling organisms when ethoxyquin is used in sea-cages. Ethoxyquin is considered efficacious in the range 25–50 mg/kg complete feed.

Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety of the coccidiostat Aviax 5% (semduramicin sodium) when used in feed for chickens for fattening. In a previous assessment, the FEEDAP Panel could not conclude on the taxonomical identification of the production strain at species level and on the absence of genetic determinants for antimicrobial resistance. In addition, the Panel could not conclude on the safety for the target animals and could not set maximum residue limits to protect consumers. Regarding the safety for the environment, although the use of the additive was considered safe for the terrestrial compartment, a risk for the aquatic compartment and for groundwater pollution could not be excluded. Based on the new data provided, the FEEDAP Panel concludes that there are no safety concerns for the target animals, consumer, user and environment regarding the production strain of semduramicin sodium. Based on the results in the tolerance trial, the FEEDAP Panel concludes that the additive is safe for chickens for fattening up to the maximum recommended level (25 mg/kg complete feed), but no margin of safety can be established. The use of semduramicin sodium at a maximum level of 25 mg/kg complete feed for chickens for fattening is safe for consumers with no withdrawal time. Based on the new data provided and the current requirements for environmental risk assessment, 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 and sediment compartments, while a risk for the terrestrial compartment cannot be excluded. The bioaccumulation and the risk for secondary poisoning are considered to be low.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-β-xylanase (Beltherm MP/ML), produced by a genetically-modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panelon Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panelconcluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panelconcluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panelconcluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panelconcluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panelcould not conclude on the efficacy of the product for the target species for which the application was made.

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 Panelon 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 Panelconcluded that the additive is efficacious to contribute to the flavour of feed.

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is to be used in to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. This additive consists of endo-1,4-β-xylanase produced by a genetically modified strain of Bacillus subtilis (LMG S-15136). In a previous opinion, the FEEDAP Panelcould not conclude on the safety of the additive for the users regarding the potential of the additive as dermal sensitiser and on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. In the absence of new information, the FEEDAP Panelretained its previous conclusion that the additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a dermal sensitiser. The applicant provided new efficacy data and complementary information regarding a previous study. Based on the previously assessed data and the newly submitted ones, the Panelconcludes that although the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period at the level of 10 IU/kg feed, the data are considered not sufficient to conclude on a beneficial effect on the performance of the litters.

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of muramidase produced by Trichoderma reesei DSM 32338 (Balancius™) as a feed additive for weaned piglets. The additive has been previously assessed by the FEEDAP Panelin the context of other applications, and in the current assessment the applicant requests for an extension of use. Based on the data available in a sub-chronic oral toxicity study, the Panelconcluded that the additive is safe for weaned piglets at the maximum recommended level of 65,000 LSU(F)/kg feed. The additive is safe for the consumers and the environment but should be considered a potential respiratory sensitiser. The Panelcould not conclude on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive has the potential to be efficacious as a zootechnical additive for weaned piglets at the dose of 50,000 LSU(F)/kg feed.

The additive Biosprint® contains viable cells of Saccharomyces cerevisiae MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to cats and dogs at a minimum inclusion level of 7 × 1010 CFU/kg of complete feed. S. cerevisiae is considered by EFSA to have qualified presumption of safety status and consequently is considered safe for the target species. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. Based on the results on efficacy studies provided, the FEEDAP Panel concludes that Biosprint® is efficacious when used in feeds for dogs. However, the FEEDAP Panel considered that the biological relevance of the magnitude of the effect detected is questionable. Based on the trial available, the FEEDAP Panel was unable to conclude on the efficacy of the additive when administered to cats.

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the feed additive consisting of four bacteriophages infecting Salmonella Gallinarum B/00111 (PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097, trade name: Bafasal®) when used as a zootechnical additive in water for drinking and liquid complementary feed for all avian species. The effects sought are the reduction of the Salmonella spp. carriage in chickens for fattening, the improvement of their performance, or both. The host strain harbours an acquired antimicrobial resistance gene. No viable cells or DNA from the host organism were found in the additive. The four phages proved to be strictly lytic and to have a machinery allowing to package a unit-length of the viral genome. The manufacturing process excludes the presence of remnants from the propagation process in the final additive. Consequently, no concerns are expected from the nature and manufacture of the product. Considering this and the results of the tolerance study with chickens for fattening, the Panelconcluded that Bafasal® is safe for all avian species. Considering the nature and manufacturing process of the additive, Bafasal® is not expected to pose a risk for consumers. The results of the subchronic oral toxicity study and genotoxicity studies provided support this conclusion. Exposure of users via inhalation is expected to be low, but Bafasal® should be considered a respiratory sensitiser. No conclusions were drawn on the irritancy of Bafasal® to skin and eyes or on its dermal sensitisation potential due to lack of data. Considering the nature and manufacturing process of the additive, Bafasal® is safe for the environment. The Panelwas not in the position to conclude on the efficacy of Bafasal® for any avian species due to insufficient data.

Following a request from the European Commission, the EFSA Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of 31 compounds belonging to different chemical groups, when used as sensory additives in feed for all animal species. Twenty-two out of the 31 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. For the remaining nine compounds, read across from structurally similar compounds was proposed. No adverse effects were observed in the tolerance studies at 10-fold the intended level. The FEEDAP Panelconcluded that the 22 compounds are safe for these species at the proposed use level and conclusions were extrapolated to all animal species for all the compounds except for α-damascone [07.134]. In the absence of data that would allow the FEEDAP Panelto rule out the genotoxicity concern, the FEEDAP Panelcannot extend the conclusions for α-damascone [07.134] to all animal species and cannot conclude on the safety for the consumer, the user and the environment. No safety concern would arise for the consumer from the use of the remaining 30 compounds up to the highest levels considered safe for target animals. The revised maximum safe levels for the 30 compounds are not expected to further impact on the previous conclusions on user safety. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds except β-damascone [07.083] and (E)-β-damascone [07.224], for which in the absence of ecotoxicity data, the FEEDAP Panelcannot conclude on the safety for the terrestrial compartments. For the marine environment, the safe use level for 2-methyl-1-phenylpropan-2-ol [02.035], α-irone [07.011], β-damascone [07.083] and (E)-β-damascone [07.224], phenethyl isovalerate [09.466], 4-(p-hydroxyphenyl) butan-2-one [07.055] and 2-isopropyl-4-methylthiazole [15.026] is confirmed to be 0.05 mg/kg.

Following a request from the European Commission, EFSA Panelon Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Bonvital® for laying hens. Bonvital® is an additive containing viable cells of Enterococcus faeciumDSM 7134 marketed in two forms, a granular and a powder form, both with a guaranteed minimum concentration of E. faeciumDSM 7134 of 1.0×1010 colony forming units (CFU)/g additive. Bonvital® in either form is intended for use in feed for laying hens at the minimum concentration of 1.0×109 CFU/kg complete feed and at the maximum concentration of 1.0×1010 CFU/kg feedingstuffs. Bonvital powder® is also proposed for use in water for drinking at the minimum concentration of 5.0×108 CFU/L. The use of Bonvital® in animal nutrition is considered safe for the target animals. The results of a tolerance trial in which hens were fed the additive at 10-fold the maximum recommended dose support this conclusion. Delivery of comparable doses of the additive via water for drinking is considered as safe for laying hens. Bonvital® at the proposed conditions of use is safe for consumers of products derived from animals fed the additive and for the environment. Bonvital® is not a dermal or ocular irritant but a potential dermal and respiratory sensitiser. Bonvital® has the potential to be efficacious in improving the hen's performance when supplemented at 1.0×109 CFU/kg feed or 5.0×108 CFU/L water for drinking.

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of 3-phytase FLF1000/FSF10000 as a feed additive for pigs for fattening and minor porcine species for growing. This additive contains 3-phytase produced by a genetically modified strain of Komagataella phaffii and it is authorised in its liquid FLF1000 and solid form FSF10000 as a feed additive for chickens for fattening, laying hens, chickens reared for laying and for minor poultry species for fattening or reared for laying or for breeding. The FEEDAP Panelhas adopted an opinion regarding the use of this product as a feed additive in pigs for fattening and minor porcine species for growing. In that opinion, the FEEDAP Panelconcluded that the use of the product as a feed additive would raise no concerns for the consumer safety nor for the environment but that the additive should be regarded as a potential respiratory sensitizer. The Panelalso concluded that the additive has a potential to be efficacious in improving the phosphorus utilisation in the target species. However, the Panelcould not conclude on the safety for the target species due to the limitations identified in the data provided. The applicant has now complemented the information and made it available to the Panel. The tolerance trial was done in weaned piglets in which the animals received up to 10 times the recommended dose of 1,000 FTU/kg feed. The results showed no adverse effects of the phytase on the performance of the animals or on the haematological and biochemical parameters measured in blood. Therefore, the Panelconcluded that the additive (3-phytase FLF1000 and FSF10000) is safe for pigs for fattening and minor growing porcine species at the recommended dose of 1,000 FTU/kg feed.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breeding and extrapolated to turkeys and all minor poultry species for fattening or reared for laying/breeding. No concerns for consumer safety are expected from the use of the additive in poultry nutrition. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the additive poses a risk to users by inhalation, and should also be considered as an irritant to skin, eyes and mucous membranes. Due to the presence of nickel, ferric tyrosine chelate should also be considered as a dermal and respiratory sensitiser. The supplementation of feed with the additive is not expected to pose an environmental risk. TYFER™ used at the minimum recommended level (20 mg/kg feed) in chickens diets has the potential to improve zootechnical parameters of birds. The additive at 20 mg/kg feed has the potential to reduce the caecal load Campylobacter spp. by at least 1 log10‐units in chickens for fattening, thus with a potential impact to reduce the risk of human campylobacteriosis; however, the Panel notes that the load of Campylobacter in the chickens caecum is one of the multiple factors that contribute to Campylobacter load in carcases‐meat. The conclusions on the efficacy of the additive can be extended to chickens reared for laying/breeding and extrapolated to turkeys and all minor poultry species for fattening or reared for laying/breeding. The Panel recommends including a specification for maximum lithium content in a potential authorisation of the additive.

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of TechnoSpore® (Bacillus coagulans DSM 32016), when used as a zootechnical additive for piglets (suckling and weaned), other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds. The bacterial species present in the additive is considered suitable for the qualified presumption of safety approach to safety assessment. The identity of the active agent was established and the lack of toxigenic potential confirmed. B. coagulans DSM 32016 did not show resistance to antibiotics of human and veterinary importance, and therefore, was presumed safe for the target species, consumers of products derived from animals Fed the additive and the environment. Since the other components of the additive did not give rise to concerns, TechnoSpore® was also considered safe for the target species, consumer and the environment. The additive is not a skin/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. TechnoSpore® showed the potential to be efficacious as a zootechnical additive in weaned piglets and chickens for fattening at 1×109 CFU/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae at the same physiological stage and to other birds for fattening and ornamental birds at the same use level. B. coagulans DSM 32016 included in Technospore® is compatible with halofuginone and diclazuril. The Panelcould not conclude on the compatibility of the additive with monensin sodium, decoquinate, robenidine hydrochloride, lasalocid sodium, narasin, salinomycin sodium, maduramicin ammonium, nicarbazin and narasin/nicarbazin.

Following a request from the European Commission, the EFSA Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy ofAxtra® XAP 104 TPT as a zootechnical feed additive (digestibility enhancers) for poultry species. The additive contains three enzyme activities (endo-1,4-beta-xylanase, protease and alpha-amylase) produced by three different genetically modified strains. Viable cells and recombinant DNA of the strains producing the protease and amylase were not detected in the final product. Owing to the insufficient data, uncertainty remained on the presence in the additive of viable cells of the strain producing the xylanase. The results obtained in the genotoxicity and subchronic oral toxicity studies performed with the three fermentation products did not indicate safety concerns resulting from the fermentation products used in the formulation/manufacturing. However, uncertainties remain on the suitability of the test item used in the studies conducted with the xylanase; therefore, the Panelwas not in the position to conclude on the toxicological potential of AXTRA® XAP 104 TPT. Consequently, the Panelcould not conclude on the safety of the additive for the target species, consumers and users. Owing to the uncertainty on the presence of viable cells of one of the production strains in the additive, the Panelcould not conclude on the safety for the environment. The FEEDAP Panelconcluded that AXTRA® XAP 104 TPT is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 U xylanase, 200 U amylase and 4,000 U protease per kg feed. Owing to the lack of sufficient data, the Panelcould not conclude on the efficacy of the additive for laying hens.

© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd 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 and efficacy of STABILFLOR® (zinc ethylenediaminetetraacetic acid (Zn-EDTA) and copper diammonium EDTA (Cu-EDTA) dried on chicory pulp and supplemented with zinc oxide and copper oxide), as a zootechnical additive for pigs. STABILFLOR® is intended to be used in feed for pigs for fattening at a minimum and maximum levels of 500 and 1,000 mg/kg complete feed, respectively. The Panel could not conclude on the safety of STABILFLOR® for pigs for fattening owing to the lack of adequate data. At the proposed used levels in feed the additive may exert antimicrobial activity in the gut microbiota. The use of the additive resulted neither in residues of Zn-EDTA, Cu-EDTA or EDTA nor on an increase in total zinc and copper deposition in edible tissues; Zn-EDTA and Cu-EDTA had not a genotoxic potential; the Panel concluded that STABILFLOR® at 1,000 mg/kg complete feed for pigs does not pose any concern to the safety of consumers. The handling of STABILFLOR® will lead to a copper exposure of the users that poses a risk by inhalation; the additive is not a skin irritant or a skin sensitiser but is a severe eye irritant. Regarding environmental safety, no concern was expected for the terrestrial compartment. A risk for groundwater was highlighted for Zn-EDTA. Due to the absence of data, the risk for the aquatic compartment could not be assessed. Only one efficacy study showed positive effects of STABILFLOR® in pigs for fattening at 1,000 mg/kg complete feed; a conclusion on the efficacy of STABILFLOR® could not be drawn. The minimum use level of 500 mg STABILFLOR®/kg complete feed was not tested.

© 2020 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 and efficacy Nimicoat® (carvacrol), as a zootechnical additive for weaned piglets. The additive is composed by carvacrol (≥ 40 %) as an active substance encapsulated with high-melting lipids. Nimicoat® is intended to be used in feed for weaned piglets at a minimum recommended dose of 250 mg/kg complete feed and at a maximum recommended dose of 1,000 mg/kg complete feed corresponding to a minimum and maximum of 100 and 400 mg carvacrol/kg complete feed, respectively. Based on a tolerance study, the FEEDAP Panel concluded that the use of Nimicoat® in feed for weaned piglet at the maximum recommended dose of 1,000 mg/kg feed is safe for the target animal; however, a precise figure for the margin of safety cannot be defined. Nimicoat® used in feed for weaned piglets at the maximum recommended concentration does not pose a safety concern for consumers. The additive is corrosive to eyes, skin and the respiratory mucosae. Concerning safety for the environment a Phase II was required; taking into consideration the data provided, the FEEDAP Panel concluded that the additive does not pose any risk to the terrestrial and aquatic compartments and that bioaccumulation potential for carvacrol is low and risk for secondary poisoning for worm/fish eating birds and mammals is not likely to occur. Only one study positively supporting efficacy of the additive was available therefore, the FEEDAP Panel is not in a position to conclude on the efficacy of Nimicoat®.

© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd 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 lignosulphonate, when used as a technological additive, functional group: binders. In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for target species and for the environment. The applicant provided additional information that was assessed in the current opinion. As regards the safety for the target species, the maximum recommended content of lignosulphonate of 10,000 mg/kg complete feed is considered safe in weaned piglet. A safe concentration of lignosulphonate in feed for salmonids and dairy cows could not be identified. The FEEDAP Panel reiterates also its previous conclusions that ‘10,000 mg lignosulphonate/kg complete feed is safe for chickens for fattening, laying hens and cattle for fattening but a margin of safety cannot be identified. Therefore, this conclusion cannot be extended to all animal species/categories’. Considering the absence of adverse effects confirmed by all the ecotoxicity studies up to very high concentrations, no concerns for the environment are expected from the use of this additive in animal nutrition according the conditions of use. Lignosulphonate is efficacious as pellet binder.

Following a request from the European Commission, the EFSA Panelon Additives and products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of OptiPhos® PLUS (6-phytase) as a zootechnical feed additive for suckling and weaned piglets, pigs for fattening, sows, other minor pig species for fattening and other minor reproductive pig species. The additive is a preparation of 6-phytase produced by a genetically modified strain of Komagataella phaffii and has been previously assessed by the FEEDAP Panelin the context of two applications for its use in different species/categories. The Panelconcluded in those opinions that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be skin irritant but was found to be a dermal sensitiser. The FEEDAP Panelcould not conclude on the eye irritation potential of the additive. Owing to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. Based on the tolerance studies provided, the Panelconcluded that the additive is safe for the target species under the conditions of use with a wide margin of safety and therefore the conclusion were extended to suckling piglets and extrapolated to other minor pig species for fattening and to other minor reproductive pig species. The FEEDAP Panelconcluded that the additive has the potential to be efficacious in weaned piglets, pigs for fattening and in sows at the level of 250 FTU/kg feed and this conclusion were extended to suckling piglets and extrapolated to other minor pig species for fattening and to other minor reproductive pig species.

© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd 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 additional data submitted on Lancer® when used as a feed additive for weaned piglets. The FEEDAP Panel considered that uncertainty still remains on possible developmental neurotoxicity of Lancer® since it was unable to identify a no observed adverse effect level (NOAEL) for this specific endpoint applying a read-across strategy from the studies provided by the applicant. However, the FEEDAP Panel considered that the exposure to La and Ce from products of animals treated with Lancer® at 250 mg/kg feed would not add a significant contribution to the background exposure of these elements. The FEEDAP Panel concluded that the use of Lancer® in feed for weaned piglets (up to 120 days) according to the proposed conditions of use, does not represent a safety concern for the consumer and for the environment.

The additive (trade name Biomin®DC-P) is a blend of five individual compounds (carvacrol, thymol, d-carvone, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for various poultry species at a minimum concentration of 65mg/kg complete feed and a recommended maximum level of 105mg/kg complete feed. The results of a tolerance study show that Biomin® DC-P is safe for chickens for fattening at the maximum recommended application rate of 105 mg/kg complete feed; this conclusion is extended to include chickens reared for laying and extrapolated to minor poultry species The active components of a previously evaluated additive (Biomin®DC-C) were shown to be not genotoxic; owing to the similarity on composition, this conclusion can be also applied to Biomin®DC-P. Notwithstanding the uncertainties identified in the residue study, after applying a worst-case scenario to calculate potential exposure of consumers to menthol and carvone, and since that the components of the additive are considered safe for their use as food and feed flavourings, the FEEDAP Panelconcludes that the use of the additive in animal nutrition is considered safe for consumers. The FEEDAP Panelconsidered that exposure of users by inhalation is unlikely, but cannot conclude on the effects of Biomin®DC-P on skin and eyes. The use of Biomin®DC-P is not expected to pose a risk for the environment. Biomin®DC-P has a potential to increase the growth performance of chickens for fattening when incorporated into feed at a minimum application rate of 65mg/kg complete feed; the conclusion can be extended to chickens reared for laying and extrapolated to minor poultry species reared up to the point of lay.