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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 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 Allura Red AC for small non‐food‐producing mammals and ornamental birds when used as an additive that add or restore colour in feedingstuffs. The use of Allura Red AC up to the proposed conditions of use of 500 mg/kg complete feed is considered safe for guinea pig, chinchilla, degu, hamster, gerbil and chipmunk. The following maximum safe levels (mg/kg complete feed) apply to the following species: ferrets 99, rabbits 123, canaries, budgerigars, mynah and toucans 45, lovebirds 51, cockatiels 79, cockatoos 115, amazons 145, parrots 147, yellow breast macaw 150, blue‐throated macaw 173 and hyacinth macaw 214. The maximum safe level of Allura Red AC for other small non‐food‐producing mammal is 99 mg/kg feed and for other ornamental birds is 45 mg/kg feed. Inhalation exposure of Allura Red is regarded as hazardous. In the absence of data, the Panel cannot conclude on the potential of Allura Red to be a skin/eye irritant or a skin sensitiser. The FEEDAP Panel cannot conclude 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 microcrystalline cellulose as a feed additive for all animal species. Microcrystalline 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 microcrystalline 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 microcrystalline cellulose meeting the food additive specifications. The FEEDAP Panel concluded that microcrystalline cellulose is considered safe for all animal species. The use of microcrystalline 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 microcrystalline cellulose for the user. The use of microcrystalline 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 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 BioWorma® (Duddingtonia flagrans NCIMB 30336) when used as a zootechnical feed additive for all grazing animals. Duddingtonia flagrans belongs to a group of nematophagous fungi that physically entrap nematodes through an adhesive hyphal net. The additive contains the fungus in the form of chlamydospores and is intended to control pathogenic nematodes on pasture, with subsequent benefits for grazing animals. No conclusions could be drawn on the safety for the target species due to lack of data. ■■■■■ As it is not possible to exclude the presence of secondary metabolites (other than flagranones) produced during fermentation and their potential carry‐over into animal products, safety for the consumer could not be established. The Panel concluded that the additive is not irritant to skin and eyes but is irritant to the respiratory tract and a respiratory sensitiser. No conclusion could be drawn on its skin sensitisation potential. Since D. flagrans is a naturally inhabiting soil organism of world‐wide distribution, the Panel considered that use of an additive based on this organism does not pose a risk for the environment under the intended conditions of use. The strain under application reduced the number of parasitic nematodes on pasture to the benefit of grazing animals when used at the recommended application rate of 3 × 104 chlamydospores/kg bodyweight and day. [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 fumonisin esterase from Komagataella phaffii DSM 32159 as a technological feed additive for all animal species. The product has been already assessed by the FEEDAP Panel for use in pigs and poultry feed as technological additive and was granted with an authorisation in the EU for this use. In the current application, the additive is intended to be used in fermenting feeds with the purpose to reduce the contamination of feed by fumonisins. New data provided showed that no recombinant DNA could be detected in three batches of the product. The evidence provided – based on the data submitted in the previous and the current application – allowed the FEEDAP Panel to conclude that the additive is safe for the target animals under the proposed conditions of use. The Panel also considered valid the previous conclusions in which the safety of the additive for consumers and the environment was established. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non‐irritant to skin and eyes and is not considered as a dermal sensitiser. The additive has the capacity to degrade fumonisins in fermenting feed (with a fumonisin content within the guidance limits operating in the EU) when used at the minimum recommended dose of 40 U/kg feed. The FEEDAP Panel notes that the efficacy has been demonstrated only in silages, not in other fermenting feeds like e.g. liquid feeds. [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 ethyl cellulose as a feed additive for all animal species. Ethyl cellulose is intended for use as a technological additive (functional group: stabiliser) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of ethyl 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 ethyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that ethyl cellulose is considered safe for all animal species. The use of ethyl 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 ethyl cellulose for the user. The use of ethyl 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 hydroxypropyl methyl cellulose as a feed additive for all animal species. Hydroxypropyl methyl cellulose is intended for use as a technological additive (functional group: stabiliser) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of hydroxypropyl 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 hydroxypropyl methyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that hydroxypropyl methyl cellulose is considered safe for all animal species. The use of hydroxypropyl 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 hydroxypropyl methyl cellulose for the user. The use of hydroxypropyl 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 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]

The tincture derived from Artemisia vulgaris L. (Mugwort tincture) is intended to be used as a sensory additive in feed for all animal species. The product is a water/ethanol solution, with a dry matter content of approximately 1.7% and is specified to contain a minimum of 0.01% hydroxycinnamic acid derivatives (expressed as chlorogenic acid). In a previous assessment, the additive was not characterised in full and about 74% of the dry matter fraction remained uncharacterised (representing 1.24% of the tincture). Therefore, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive at the proposed use levels of up to 400 mg/kg complete feed for all animal species or for the consumer. The applicant has provided new data which show that the unidentified fraction consists of crude fibre, other carbohydrates, and protein; none of which are considered of concern. Consequently, the Panel concludes that the additive is safe when used at the proposed use level of 400 mg/kg feed for all animal species. No concerns for consumer safety were identified following the application of the additive at the proposed use level in animal nutrition. [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 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 Panel in the context of two applications for its use in different species/categories. The Panel concluded 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 Panel could 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 Panel concluded 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 Panel concluded 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. [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 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 Panel has 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 Panel concluded 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 Panel also concluded that the additive has a potential to be efficacious in improving the phosphorus utilisation in the target species. However, the Panel could 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 Panel concluded 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. [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‐lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 when used as a nutritional additive in feed for all animal species. The active substance is l‐lysine. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment and was not detected in the final product. l‐Lysine sulfate produced using C. glutamicum KFCC 11043 does not pose any safety concern associated with the production strain. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is considered safe for the target species. When using l‐lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is safe for the consumer and for the environment. From the results of studies on the safety for the user of l‐lysine sulfate produced by a different production strain, it was possible to conclude on the safety for the user of the product under assessment. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is considered non‐toxic by inhalation, non‐irritant to skin or eyes and it is not a skin sensitiser. l‐lysine sulfate is considered as an efficacious source of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Lactobacillus parafarraginis DSM 32962 when used as a technological additive intended to improve the production of silage at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The bacterial species L. parafarraginis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive is not an eye or dermal irritant but should be considered a potential respiratory sensitiser. No conclusions can be drawn on the skin sensitisation potential of the additive. Three studies with laboratory‐scale silos were made using samples of easy and moderately difficult to ensile forage. In each case, replicate silos containing untreated forage were compared with identical silos containing the same forage to which Lactobacillus parafarraginis DSM 32962 was added to reach an intended concentration of 1 × 108CFU/kg fresh matter. The results showed that the addition of the additive improves significantly the aerobic stability of the silage tested. [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 and efficacy of Axtra®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 Panel was not in the position to conclude on the toxicological potential of AXTRA®XAP 104 TPT. Consequently, the Panel could 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 Panel could not conclude on the safety for the environment. The FEEDAP Panel concluded 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 Panel could not conclude on the efficacy of the additive for laying hens. [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 Actisaf® Sc 47 (Saccharomyces cerevisiae CNCM I‐4407) as a zootechnical additive for calves for rearing. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for calves for rearing, consumers and the environment under the authorised conditions of use. The additive is not a skin or eye irritant. In the absence of data, no conclusions can be drawn on the dermal sensitisation potential of the additive. Inhalation exposure is unlikely. 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 sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. It is currently authorised in the European Union and it is intended to be used as a technological additive (functional group of emulsifiers), in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. In 2019, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sorbitan monolaurate. Owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. The applicant submitted new data (fate and degradation as well as ecotoxicity data) that were evaluated in the present opinion. The absorption, distribution, metabolism and excretion of structurally related compounds (sorbitan monostearate and sorbitan trioleate) indicate that the additive is expected to be partially metabolised. In addition, sorbitan monolaurate and some related compounds are readily biodegradable. The limited available data on the effects of sorbitan monolaurate in marine crustaceans and in marine sediment indicate that the ecotoxicity of the additive is low, in consistency with the very low acute toxicity of sorbitan esters. Overall, the FEEDAP Panel concludes that a risk of sorbitan monolaurate to terrestrial and aquatic environment is unlikely. Therefore, no safety concerns for the environment are expected from the use of the additive under assessment according to the established 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 Lactobacillus buchneri DSM 29026 when used as a technological additive to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 108 colony‐forming units (CFU)/kg forage if used alone, or 5 × 107CFU/kg forage if used in combination with other authorised microorganisms. The bacterial species L. buchneri is considered by the EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The FEEDAP Panel concluded that Lactobacillus buchneri DSM 29026 at a minimum concentration of 5 × 107CFU/kg may improve the production of silage from easy and moderately difficult to ensile forage material. [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 vermiculite as a feed additive for pigs, poultry, bovines, sheep, goats, rabbits and horses. Vermiculite, which is a magnesium aluminium iron silicate, is intended for use as a technological additive (functional groups: binders and anticaking agents) in premixtures and feedingstuffs for pigs, poultry, bovines, sheep, goats, rabbits and horses, with no proposed minimum or maximum concentration. The applicant reported a maximum inclusion level, derived from the use of the additive in premixtures of preservatives, of about 50,000 mg/kg complete feed, and suggested typical inclusion levels in complete feedingstuffs below 10,000 mg/kg. The FEEDAP Panel could not conclude on the safety of vermiculite for the target species and the users. The additive is considered safe for the consumer and the environment at the proposed conditions of use. In the absence of data, the Panel could not conclude on the efficacy of vermiculite as a pellet binder or 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 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 × 109CFU/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 Panel could 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. [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 ProEquo® as a feed additive for horses. This additive is a preparation single strain of Lactobacillus plantarum intended for use as a zootechnical additive in feed for horses. The identity of the bacterial strain was not established. Consequently, the qualified presumption of safety approach to safety assessment cannot be applied, and separate studies on target animals, consumer and environmental safety are required. The tolerance trial provided could not be considered due to non‐compliance with the minimum requirements. No additional studies or data were provided for the other safety aspects. Therefore, in the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of ProEquo® for the target animals, consumers of products derived from animals fed the additive and the environment. ProEquo® should be considered a respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or on its dermal sensitisation potential. The FEEDAP Panel is not in the position to conclude on the efficacy of ProEquo® for horses. [ABSTRACT FROM AUTHOR]

Selenium‐enriched yeast produced by Saccharomyces cerevisiae CNCM I‐3399 (selenised yeast inactivated) (SELSAF) is characterised as organic selenium mainly containing selenomethionine (Se‐Met, ≥ 63%). The applicant requested for the renewal of the authorisation for selenium‐enriched yeast produced by S. cerevisiae CNCM I‐3399 when used as a feed additive for all animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of selenium‐enriched yeast produced by S. cerevisiae CNCM I‐3399 under the current authorised conditions of use is safe for the target species, the consumers and the environment. The additive is non‐irritant to skin and eyes but should be considered a respiratory sensitiser. No conclusion can be reached on its dermal sensitising properties. The additive is hazardous by inhalation. Exposure of users by inhalation is very likely. 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 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 APSA PHYTAFEED® 20,000 GR/L (6‐phytase) as a zootechnical feed additive for laying hens and other poultry species for laying. 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 Panel in the context of three applications for its use in different species/categories. The Panel concluded 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 irritant to skin or eyes or a dermal sensitiser but it should be considered as a respiratory sensitiser. The Panel considered that the new use in laying hens and other poultry species for laying would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial in laying hens and a subchronic oral toxicity study were made available to support the safety of the additive for the target species/categories subject of this new application; from the results obtained, the Panel concluded that the additive is safe for laying hens at the recommended level of use (300 U/kg feed) with a wide margin of safety and therefore the conclusion was extrapolated to other laying birds. The FEEDAP Panel concluded that the additive has the potential to be efficacious in laying hens at the level of 300 U/kg feed and this conclusion was extrapolated to other laying birds. [ABSTRACT FROM AUTHOR]

In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of ammonium, calcium and sodium formate when used as a technological additive (preservative) for all animal species. Sodium formate was considered safe for all animal species at a maximum concentration of 10,000 mg formic acid equivalents/kg complete feed (with the exception of pigs, for which a maximum concentration of 12,000 mg formic acid equivalents/kg complete feed was considered safe). Sodium formate was also considered safe for the consumer and the environment. The Panel also concluded that sodium formate is non‐irritant to the skin, but mildly irritant to the eyes, and is a respiratory irritant with a potential for sensitisation. The Panel also concluded that 'Sodium formate or solid sodium formate had no discernible effects on microbial numbers in the feed materials examined. The preservative effect of the three formate salts in water for drinking was not demonstrated'. In the current opinion, additional data to demonstrate the efficacy of sodium formate as a preservative in feed for all animal species were assessed. The Panel concluded that sodium formate has the potential to be efficacious as a preservative in feedingstuffs for all animal species at the proposed use level. In the absence of data, the Panel cannot conclude on the efficacy of the use of the additive in water for drinking. [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 disodium 5′‐inosinate (IMP) produced by fermentation using Corynebacterium stationis KCCM 80161 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is not genetically modified. Viable cells of the production strain were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. IMP produced using C. stationis KCCM 80161 is considered safe for the target species, for the consumer and for the environment. IMP produced using C. stationis KCCM 80161 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. The FEEDAP Panel expressed reservations on the use of the additive in water for drinking due to concerns on its impact on the hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed. [ABSTRACT FROM AUTHOR]

The additive perlite (sodium potassium aluminium silicate) is intended to be used as a technological additive (functional group: anticaking agents) for ruminants and poultry. 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 and identification, the safety for the target species and user, 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 perlite as a technological additive for ruminants and poultry. [ABSTRACT FROM AUTHOR]

In 2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of calcium formate when used as a technological additive (preservative) for all animal species. Calcium formate was considered safe for all animal species at a maximum concentration of 10,000 mg formic acid equivalents/kg complete. Calcium formate was also considered safe for the consumer and the environment. The Panel also concluded that 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 Panel also concluded that 'Data submitted do not provide convincing evidence of the efficacy of the additive when used as a preservative for compound feed or feed materials'. In the current opinion, additional data to demonstrate the efficacy of calcium formate as a preservative in feed for all animal species were assessed. The Panel concluded that calcium formate has the potential to be efficacious as a preservative in feedingstuffs for all animal species at the proposed use level. [ABSTRACT FROM AUTHOR]

Following a request from European Commission, the Panel on Additives and Products or Substances used in animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of authorisation of montmorillonite‐illite (FIMIX 1g557) for all animal species. The FEEDAP Panel adopted in 2014 an opinion on the safety and in 2015 on the efficacy of this additive. The additive montmorillonite‐illite (FIMIX 1g557) is currently authorised for use in feedingstuffs for all animal species as an anticaking agent with a minimum and a maximum content of 20,000 mg/kg. The applicant proposed to use the additive in premixtures and complementary feeds for all animal species and categories at a minimum concentration of 20,000 mg/kg premixture and 10,000 mg/kg complementary feeds. The FEEDAP Panel considers that the proposed modification (reduction of the inclusion level in feed) would not affect the conclusions reached in the previous assessment as related to the safety for the target species, consumers, users and the environment. Montmorillonite‐illite is efficacious as an anticaking agent in premixtures for all animal species at inclusions levels starting at 20,000 mg/kg premixture and in complementary feeds at inclusions levels starting at 10,000 mg/kg. When the premixtures or complementary feeds are incorporated into complete feed, the concentration of montmorillonite‐illite would range from 50 to 100 mg/kg complete feed for poultry and all other animal species, respectively. There is no evidence that the anticaking effect of the additive will persist at these concentrations in complete feed. In the absence of specific data, the FEEDAP Panel is not in the position to comment on the efficacy of the additive at these concentrations when used in complete feed. [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 and efficacy of Biacton® when used as a feed additive for weaned piglets. Biacton® is a preparation of viable cells of Lactobacillus farciminis CNCM I‐3740 intended to be incorporated into feed for weaned piglets at a minimum recommended application level of 1 × 109 CFU/kg complete feed. L. farciminis is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. Biacton® is not irritant to skin, eyes or to the respiratory tract, but should be considered a prespiratory sensitiser. In the absence of data, no conclusions could be drawn on the potential skin sensitisation potential of the additive. No conclusion can be drawn on the efficacy of Biacton® for weaned piglets based on the data available. [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 and efficacy of Sorbiflore®ADVANCE when used as a zootechnical feed additive for weaned piglets. Sorbiflore®ADVANCE results from the fermentation of milk based‐broth with Lactobacillus rhamnosus CNCM I‐3698 and Lactobacillus farciminis CNCM I‐3699. The additive is intended for use in feed for weaned piglets at the minimum concentration of 1.25 × 108 viable forming units (VFU)/kg and the maximum concentration of 5 × 108VFU/kg complete feed. The data submitted did not allow a full characterisation of the additive, and therefore, uncertainty remains on the nature of the product in terms of viability, on the ratio between the active agents and on the stability of the additive. The active agents fulfil the requirements of the qualified presumption of safety (QPS) approach to the assessment of safety and no concerns are expected from other components of the additive. Consequently, Sorbiflore®ADVANCE is presumed to be safe for the target animals, consumers of products from animals receiving the additive and the environment. The additive should be considered a respiratory sensitiser. In the absence of data, no conclusions could be drawn on the irritancy of Sorbiflore®ADVANCE to skin and eyes and on its dermal sensitisation potential. Sorbiflore®ADVANCE at 1.25 × 108VFU/kg feed has the potential to be efficacious in weaned piglets. [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 and efficacy of Sorbiflore®ADVANCE when used as a zootechnical feed additive for chickens for fattening. Sorbiflore®ADVANCE is an additive resulting from the fermentation of milk‐based broth with Lactobacillus rhamnosus CNCM I‐3698 and Lactobacillus farciminis CNCM I‐3699. Sorbiflore®ADVANCE is intended for use in feed for chickens for fattening at the minimum concentration of 5 × 107 Viable Forming Units (VFU)/kg and the maximum concentration of 2 × 108VFU/kg complete feed. The data submitted did not allow a full characterisation of the additive, and therefore, uncertainty remains on the nature of the product in terms of viability, on the ratio between the active agents and on the stability and homogeneity of the additive. The active agents fulfil the requirements of the Qualified Presumption of Safety (QPS) approach to the assessment of safety and no concerns are expected from other components of the additive. Consequently, Sorbiflore®ADVANCE is presumed to be safe for the target animals, consumers of products from animals receiving the additive and the environment. The additive should be considered a respiratory sensitiser. In the absence of data, no conclusions can be drawn on the irritancy of Sorbiflore®ADVANCE to skin and eyes and on its dermal sensitisation potential. Sorbiflore®ADVANCE at 2 × 108VFU/kg feed has the potential to be efficacious in chickens for fattening. [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 l‐valine (≥ 98.0%) produced by fermentation using a genetically modified strain of Escherichia coli (KCCM 80159). It is intended to be used in feed for all animal species and categories. Species identity of the production organism E. coli KCCM 80159 was confirmed; the strain was sensitive to antibiotics at concentrations below or equal to thresholds specified by EFSA; and no viable cells or its recombinant DNA were detected in the final product. Therefore, the final product does not give raise to any safety concern with regard to the genetic modification of the production strain. The FEEDAP Panel concludes that l‐valine produced by E. coli KCCM 80159 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species, for the consumer, for the users and for the environment. The product l‐valine produced by fermentation using E. coli KCCM 80159 is regarded as an efficacious source of the essential amino acid l‐valine for non‐ruminant nutrition. For the supplemental l‐valine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. [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 l‐glutamine (≥ 98.0%) produced by fermentation using a genetically modified strain of Corynebacterium glutamicum (NITE BP‐02524). It is intended to be used in feed for all animal species and categories as nutritional additive (amino acid) and as sensory additive (flavouring compound). Viable cells of the production strain and its recombinant DNA were not detected in the additive. l‐Glutamine manufactured by fermentation using C. glutamicum NITE BP‐02524 does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l‐glutamine produced by fermentation using C. glutamicum NITE BP‐02524 in animal nutrition is considered safe for all animal species when applied as a nutritional additive to achieve an adequate amino acid profile in feed and to overcome potential glutamine shortages during critical periods of life. The proposed use level (25 mg/kg feed) when used as sensory additive (flavouring compound) is safe for all animal species. The uses of l‐glutamine produced using C. glutamicum NITE BP‐02524 as nutritional additive or as flavouring compound are considered safe for the consumer. l‐Glutamine produced using C. glutamicum NITE BP‐02524 is not toxic by inhalation, is non‐irritant to skin and eyes and is not a skin sensitiser. l‐Glutamine produced using C. glutamicum NITE BP‐02524 is considered safe for the environment. l‐glutamine is a non‐essential amino acid and it plays a physiological role as such. Recent evidence shows that glutamine may act as conditionally essential amino acid mainly in growing animals and has some specific effects e.g. in improving intestinal development and immune response. This amino acid produced by fermentation using C. glutamicum NITE BP‐02524 is regarded as an efficacious source of glutamine for all animal species. For supplemental l‐glutamine to be as efficacious in ruminants as in non‐ruminants, it would require protection against degradation in the rumen. The use of l‐glutamine as sensory additive at 25 mg/kg feed is considered efficacious. [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 l‐cysteine monohydrochloride monohydrate produced by fermentation using two non‐genetically modified strains of Escherichia coli K12 (E. coli KCCM 80109 and E. coli KCCM 80197) as a flavouring additive for all animal species. No safety concerns are derived from the use of these strains as production strains of the additive. The FEEDAP Panel concludes that the use of l‐cysteine hydrochloride monohydrate produced by E. coli KCCM 80109 and KCCM 80197 at concentrations up to 25 mg/kg complete feed is safe for the target species, for the consumer and for the environment. The product is proposed to be classified as respiratory irritant; however, exposure by inhalation is unlikely. Based on the results of the studies provided, it should be classified as skin irritant and that it causes serious eye damage. l‐Cysteine hydrochloride monohydrate is not a dermal sensitiser. Since l‐cysteine hydrochloride monohydrate is used in food as flavourings, it is to be expected that it can provide a similar function in feed and no further demonstration of efficacy is necessary when used at concentrations up to 25 mg/kg complete feed and the corresponding concentration in water. [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 GalliPro® Fit (Bacillus subtilis DSM 32324, B. subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840) when used as a zootechnical additive in feed and water for drinking for all poultry species for fattening or reared for laying/breeding. The two bacterial species present in the additive are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agents was established and the lack of toxigenic potential confirmed. The strains did not show resistance to relevant antibiotics. Therefore, the additive was presumed safe for the target species, consumers and the environment. In the absence of data, no conclusions could be drawn on the skin/eye irritancy or skin sensitisation of the additive. Due to the proteinaceous nature of the active agents, the additive was considered a respiratory sensitiser. The Panel concluded that GalliPro® Fit is compatible with diclazuril, decoquinate and halofuginone. However, the data provided did not allow to conclude on the compatibility of the additive with other coccidiostats. The Panel concluded that the additive has a potential to be efficacious in chickens for fattening at 1.6 × 109CFU/kg feed and at 5.4 × 108CFU/L water for drinking. The conclusion was extrapolated to all other poultry species for fattening or reared for laying/breeding. The results from the study in turkeys support this conclusion. [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 and efficacy of Capsozyme SB Plus as a zootechnical feed additive (digestibility enhancers) for poultry species and ornamental birds. The additive contains two enzyme activities (α‐galactosidase and endo‐1,4‐β‐xylanase) and it is presented in solid form. The α‐galactosidase is produced by a non‐genetically modified strain of Aspergillus tubingensis and the xylanase is produced by a non‐genetically modified strain of Trichoderma longibrachiatum. Based on the results obtained in a tolerance trial performed in chickens for fattening, the FEEDAP Panel concluded that the additive is safe for the target species at the recommended levels. The mixture of the two enzyme concentrates that are used to formulate the additive, did not show any potential for a genotoxic effect in a bacterial reverse mutation assay and an in vitro mammalian cell micronucleus test. However, owing to the limitations identified in the subchronic oral toxicity study, the Panel could not conclude on the toxicological potential of the additive. No studies were submitted by the applicant to address the safety aspects related to the user. Therefore, the Panel could not conclude on the skin or eye irritation potential of the additive nor on its skin sensitisation potential. Owing to the proteinaceous nature of the additive it should be regarded as a potential respiratory sensitiser, but the exposure is presumed to be limited due to the low dusting potential. The Panel considered that the product, used as feed additive, poses no risks to the environment and no further environmental risk assessment is required. The Panel considered a total of five efficacy trials, however, the limited evidence of the efficacy provided by those studies did not allow the Panel to conclude on the efficacy. [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 monosodium l‐glutamate monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80188 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is not genetically modified. Viable cells of the production strain were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. Monosodium l‐glutamate monohydrate produced using C. glutamicum KCCM 80188 is considered safe for the target species, for the consumer and for the environment. Monosodium l‐glutamate monohydrated produced by C. glutamicum KCCM 80188 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. The FEEDAP Panel expressed reservations on the use of the additive in water for drinking due to concerns on its impact on the 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 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 Lactobacillus rhamnosus CNCM I‐3698 and Lactobacillus farciminis CNCM I‐3699 when used as a silage additive in forage for all animal species. The additive is the result from the fermentation of milk‐based broth with L. rhamnosus CNCM I‐3698 and L. farciminis CNCM I‐3699. It is intended to be used in easy and moderately difficult to ensile materials at a minimum proposed application rate of 2.5 × 107 and maximum 8 × 107VFU/kg complete feed for all animal species. The data provided do not allow a full characterisation of the additive, and therefore, uncertainty remains on the nature of the product in terms of viability, on the ratio between the active agents and on the shelf‐life of the additive. Both strains fulfil the requirements of the Qualified Presumption of Safety (QPS) approach to the assessment of safety and consequently, are presumed safe for the target animals, consumers of products from animals receiving the additive and the environment. The additive should be considered a respiratory sensitiser. In the absence of data, no conclusions can be drawn on the irritancy of the additive to skin and eyes or on its dermal sensitisation potential. No conclusions can be drawn on the efficacy of the additive to improve the ensiling process of easy and moderately difficult to ensile materials. [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 and efficacy of Biacton® when used as a feed additive for chickens for fattening, turkeys for fattening and laying hens. Biacton® is a preparation of viable cells of Lactobacillus farciminis CNCM I‐3740 intended for use in feed for chickens for fattening, turkeys for fattening and laying hens at a minimum recommended application level of 5 × 108CFU/kg complete feedingstuffs. L. farciminis is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment, and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In the absence of data, no conclusions can be drawn on the irritancy of Biacton® to skin and eyes or on its dermal sensitisation potential. The additive should be considered a respiratory sensitiser. Due to poor reporting and significant limitations in the data available, the FEEDAP Panel cannot conclude on the efficacy of the additive for chickens for fattening, turkeys for fattening and laying hens. [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 efficacy of Cygro® 10G. The active substance of Cygro® 10G is the polyether ionophore maduramicin ammonium‐α, a coccidiostat intended to be used in feed for turkeys for fattening. In a former opinion, the FEEDAP Panel concluded that the efficacy of Cygro® 10G in turkeys for fattening had not been sufficiently demonstrated. In the present submission, new efficacy studies have been provided by the applicant. A positive effect of Cygro® 10G in preventing coccidiosis in turkeys was shown in three anticoccidial sensitivity tests (ASTs). However, owing to the lack of floor pen studies showing a positive effect, the FEEDAP Panel is not in the position to conclude on the efficacy of Cygro® 10G for turkeys for fattening. [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‐lysine monohydrochloride produced by fermentation with the genetically modified strain of Corynebacterium glutamicum DSM 32932. Neither the production strain nor its recombinant DNA were detected in the final product. The additive does not pose any safety concern associated with the genetic modification of the production strain. l‐Lysine HCl produced by C. glutamicum DSM 32932 is considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum DSM 32932 is not toxic by inhalation; it is not irritant to skin and not a skin sensitiser. The additive is not corrosive to eyes but it should be considered as an eye irritant. In general, l‐lysine HCl is considered as an efficacious source of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. [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 ammonium formate for all animal species. In 2015, the FEEDAP Panel delivered an opinion on the safety and efficacy of ammonium formate, calcium formate and sodium formate. In that opinion, the Panel considered the unavoidable presence of formamide, as a contaminant of ammonium formate, of concern for developmental toxicity for reproduction animals and for carcinogenicity for non‐food‐producing animals. Regarding the safety for the consumer, the Panel concluded that: the use of the additive in dairy animals and laying poultry may raise concerns due to the potential exposure of consumers to formamide. In the current submission, the applicant proposed to reduce the maximum content of ammonium formate in feed to 2,000 mg formic acid equivalent/kg feed from the previously proposed 12,000 mg/kg for pigs and 10,000 mg/kg for all other animal species. Based on the calculation of the maximum safe concentration of formamide in feed, the FEEDAP Panel cannot conclude on the safety of ammonium formate in complete feed for laying hens and sows, since the calculate maximum concentration of formamide in feed (11.5 mg formamide/kg) exceed the maximum safe concentration in feed for these species (5.6 mg formamide/kg for laying hens and 9.9 mg formamide/kg for sows). Based on the results of a residue study in eggs, the use of ammonium formate in animal nutrition at a maximum content of 2,000 mg formic acid equivalent/kg complete feed would not result in concerns on the safety for the consumer. [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‐histidine monohydrochloride (HCl) monohydrate produced by fermentation using Escherichia coli NITE SD 00268 in the context of the renewal of the authorisation for salmonids when used as a nutritional additive. In addition, the applicant requested the extension of use of the additive for other fin fish. The applicant has provided evidence that the composition of the additive currently in the market complies with the conditions of authorisation. The production strain has been modified by conventional mutagenesis and it does not raise safety concerns. The use of l‐histidine HCl monohydrate produced by fermentation using E. coli NITE SD 00268 is safe for salmonids and other fin fish when used as a nutritional additive to supplement the diet in appropriate amounts to cover the nutritional requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. The FEEDAP Panel considers the maximum total concentration of 1.7% histidine in feed for salmonids proposed by the applicant as safe. For other fin fish species, the level of 1.7% appears to cause adverse effects. Therefore, it is not possible to define a maximum concentration of histidine in fish other than salmonids as it depends on histidine nutritional requirements in the different fish species. The use of the authorised additive in salmonids production does not pose a risk for consumers, and the proposed maximum total concentration of 1.7% histidine in feed is considered safe for the consumer. l‐Histidine HCl monohydrate produced using E. coli NITE SD 00268 supplemented at levels appropriate to cover the nutritional requirements of fish other than salmonids is considered safe for the consumer. The additive under assessment is not a skin irritant. In the absence of data, it is not possible to conclude on the potential of the additive to be toxic by inhalation, irritant to eyes or a skin sensitiser. The amino acid l‐histidine is a natural component of plants and animals. The use of the additive under assessment in animal nutrition does not represent a risk to the environment. The additive is considered an efficacious source of the amino acid l‐histidine for fish species. [ABSTRACT FROM AUTHOR]