Search

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B12 (cyanocobalamin) produced by fermentation with a non‐genetically modified strain of Ensifer adhaerens (CGMCC 21299), when used as a nutritional additive for all animal species. No viable cells or DNA of the production strain were detected in the additive. Therefore, cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 does not raise safety concerns as regards to the production strain. The Panel on Additives and Products or Substances used in Animal Feed concluded that cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 is considered safe for all animal species, for the consumers and the environment. Due to the presence of nickel, the additive is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. Due to the lack of data, the Panel could not conclude on the potential of the additive to be an eye irritant. Cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 is effective in meeting animal's nutritional requirements when administered via feed. [ABSTRACT FROM AUTHOR]

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 for the users of the feed additive consisting of ferric tyrosine chelate (TYFER™) when used as a zootechnical additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The European Commission request follows a previous opinion of the FEEDAP Panel. In that opinion, the Panel identified several risks for the users of the additive; it was listed that it posed a risk to users by inhalation, should be considered as an irritant to skin, eyes and mucous membranes, and also that, due to its nickel content, should be considered as a dermal and respiratory sensitiser. In the current application, the applicant proposed a maximum content of nickel (50 mg/kg). No changes in the manufacturing process have been reported by the applicant. In the absence of new data, the FEEDAP Panel reiterates its previous conclusion that the additive should be as an irritant to skin, eyes and mucous membranes and as a dermal and respiratory sensitiser. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive obtained from the dried leaves of Ginkgo biloba L. (ginkgo extract) when used as a sensory additive in feed for horses, dogs, cats, rabbits and guinea pigs. Ginkgo extract contains ≥ 24% total flavonoids, ≥ 6% total terpene lactones and ≤ 1 mg/kg ginkgolic acids. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ginkgo extract is safe for the target species at the following concentrations in complete feed: 2.8 mg/kg for horses and cats, 1.1 mg/kg for rabbits and guinea pigs, and 3.3 mg/kg for dogs. No safety concern would arise for the consumers from the use of ginkgo extract up to the highest level in feed which is considered safe for food‐producing species (horses and rabbits). The additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the additive at the proposed level in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that the ginkgo extract would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additive. [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 cajuput oil obtained from fresh leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L., when used as a sensory additive for all animal species. The FEEDAP Panel concluded that cajuput oil is safe up to the maximum proposed use levels in complete feed of 30 mg/kg for sows and dogs, 50 mg/kg for horses and ornamental fish, 40 mg/kg for salmon and 5 mg/kg for cats. For the other species, the calculated safe concentrations were 18 mg/kg for chickens for fattening, 26 mg/kg for laying hens, 23 mg/kg for turkeys for fattening, 37 mg/kg for pigs for fattening, 31 mg/kg for piglets, 78 mg/kg for veal calves (milk replacer), 69 mg/kg for cattle for fattening and sheep/goats, 45 mg/kg for dairy cows and 28 mg/kg for rabbits. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 5 mg/kg complete feed. The use of cajuput oil in water for drinking was considered safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. The essential oil under assessment should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since cajuput oil was recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried fruit of Schisandra chinensis (Turcz.) Baill. (omicha tincture), when used as a sensory additive in feed for horses, cats, dogs, and in feed and in water for drinking for poultry. The product is a water/ethanol (55:45 v/v) solution, with a dry matter content of not more than 4% (w/w) and a content of 0.01%–0.15% (w/w) for the sum of schisandrin and deoxyschisandrin. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that omicha tincture is safe at the following concentrations in complete feed: 16 mg/kg for turkeys for fattening, 12 mg/kg for chickens for fattening and other poultry for fattening or reared for laying/reproduction, 18 mg/kg for laying hens and other laying/reproductive birds, 56 mg/kg for dogs and 47 mg/kg for horses and cats. The additive is considered safe for consumers when used up to the highest safe level in feed for poultry species and horses. Omicha tincture should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of omicha tincture as a flavour in feed for poultry species and horses was not considered to be a risk to the environment. Since it was recognised that the fruit of S. chinensis can influence sensory properties of feedingstuffs, no further demonstration of efficacy was considered necessary for the tincture under assessment. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of Panax ginseng C.A.Mey. (ginseng tincture), when used as a sensory additive in feed for horses, dogs and cats. The product is a water/ethanol (40:60 v/v) solution, with a dry matter content of no more than 6% and a content of 0.01%–0.5% (w/w) for the sum of the two triterpene saponins ginsenoside Rb1 and ginsenoside Rg1. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the tincture is safe for horses, dogs and cats at the maximum proposed use level of 48.6, 228.7 and 162 mg/kg complete feed, respectively. The Panel also concluded that the additive is considered safe for consumers when used at the proposed conditions of use in feed for horses. Ginseng tincture should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the ginseng tincture as a flavour in feed for horses was not expected to pose a risk for the environment. Since the roots of P. ginseng and its preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lanthanum carbonate octahydrate as a zootechnical feed additive for dogs. The additive is already authorised for use in feed for cats. The FEEDAP Panel concluded that the additive lanthanum carbonate octahydrate is safe for adult dogs at the maximum recommended level of 7500 mg/kg complete feed. The additive is not irritant to skin or eyes, is not a skin sensitiser and exposure by inhalation is considered to be unlikely. The Panel also concluded that lanthanum carbonate octahydrate is efficacious in the reduction of phosphorus bioavailability in adult dogs at the minimum inclusion level of 1500 mg/kg complete feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as a nutritional feed additive for use in feed and in water for drinking for all animal species. The production strain is non‐genetically modified, qualifies for the QPS approach to safety assessment when used for production purposes, is susceptible to the relevant antibiotics and contains no antimicrobial resistance genes of concern. No viable cells of the production strain were detected in the final product. The additive does not give rise to any safety concern regarding the production strain. l‐Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered safe for the target species, the consumer and the environment. Regarding the use in water, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reiterates its concerns over the safety for the target species of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. In the absence of data, the FEEDAP Panel is not in a position to conclude on the potential of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the high dusting potential, exposure by inhalation is likely. l‐Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered as an efficacious source of the essential amino acid l‐isoleucine for non‐ruminant animal species. For the supplemental l‐isoleucine 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, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Levilactobacillus brevis DSM 21982 as a technological feed additive, silage additive, for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the additive should be considered as a skin and respiratory sensitiser. No conclusions can be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Patent Blue V as a sensory feed additive for non‐food‐producing animals. The additive is already authorised for use with non‐food‐producing animals. The applicant has not provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel cannot conclude whether the additive remains safe for the target species due to the non‐compliance with the specifications and the lack of adequate data on the potential aneugenicity of the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a dermal and eye irritant nor a dermal and respiratory sensitiser. Since the potential genotoxicity of the additive was not ruled out, the exposure to the additive of the unprotected users should be minimised. The Panel retains that the previously made conclusion on the efficacy remains valid. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation regarding the maximum inclusion level of a feed additive consisting of 4‐hydroxy‐2,5‐dimethylfuran‐3(2H)‐one for cats and dogs. 4‐Hydroxy‐2,5‐dimethylfuran‐3(2H)‐one is currently authorised for use as a sensory additive (functional group: flavouring compounds) for cats and dogs at a recommended maximum content of 5 mg/kg complete feed. The applicant is requesting a modification of the authorisation to increase the recommended maximum content of the additive up to 25 mg/kg complete feed for cats and dogs. Based on the toxicological data available, the FEEDAP Panel concludes that 4‐hydroxy‐2,5‐dimethylfuran‐3(2H)‐one is safe for dogs at 25 mg/kg feed and for cats at 18 mg/kg feed. The additive is irritant to skin, eyes and to the respiratory tract and is a skin sensitiser. No further demonstration of efficacy is necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l‐threonine produced by fermentation with Escherichia coli CGMCC 7.455 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain is genetically modified. None of the introduced genetic modifications raised a safety concern. Viable cells of the production strain and its DNA were not detected in the final additive. Therefore, the final product does not give raise to any safety concern regarding the genetic modification of the production strain. The use of l‐threonine (≥ 98.5%) produced with E. coli CGMCC 7.455 to supplement feed is safe for the target species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns on the safety of the simultaneous oral administration of l‐threonine via water for drinking and feed due to possible amino acid imbalances and hygienic reasons. The use of l‐threonine produced with E. coli CGMCC 7.455 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity in the additive does not pose a risk for the user via inhalation. The additive l‐threonine is regarded as an effective source of the amino acid l‐threonine for all non‐ruminant species. In order to be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Pediococcus pentosaceus DSM 14021, a technological additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the Panel considers that any exposure through skin and respiratory tract is considered a risk. The Panel cannot conclude on the eye irritation potential of the additive due to the lack of data. 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, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the selenised yeast (inactivated) Saccharomyces cerevisiae CCTCC M 2022402 (Plexomin® Se 3000, available in two forms: 'granules' and 'micro') as a nutritional feed additive for all animal species. Based on a tolerance–efficacy trial, the FEEDAP Panel concluded that the additive is safe for chickens for fattening at proposed conditions of use and this conclusion can be extrapolated to all animal species. In the absence of deposition data in all animal species and products, the FEEDAP Panel cannot conclude on the safety for the consumer. Plexomin® Se 3000 (granules) is dust‐free; therefore, the exposure through inhalation is unlikely. Plexomin® Se 3000 (micro) presents a risk by inhalation. Both forms of the additive (granules and micro) are considered as respiratory sensitisers. Due to the lack of data, no conclusions can be drawn on the dermal and eye irritation potential of Plexomin® Se 3000 (granules). Plexomin® Se 3000 (micro) is not irritant to the skin and the eyes. No conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. The use of the additive in animal nutrition is considered safe for the environment. The additive is an efficacious source of selenium 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 6‐phytase produced by the genetically modified strain Aspergillus oryzae DSM 33737 (HiPhorius™ 10, 40, 20L and 50L) as a zootechnical feed additive for all poultry, all Suidae and all fin fish. The FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry, all Suidae and all fin fish at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive is of no concern for the consumers and the environment. The liquid formulations of the additive are not skin or eye irritants. The two solid ones are not skin irritants but are eye irritants. Owing to the lack of data, the Panel cannot conclude on the skin sensitisation of the final formulations of the additive. Due to the proteinaceous nature of the active substance (6‐phytase), the additive is considered a respiratory sensitiser. The Panel concludes that the additive is efficacious when included in the diet of poultry for fattening or reared for laying/breeding, reproductive Suidae, and all fin fish. Due to the lack of sufficient data, the Panel could not conclude on the efficacy for laying and reproductive poultry and growing Suidae. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of magnesium l‐threonate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF, produced by chemical synthesis, is intended to be used as new source for magnesium in food supplements at a maximum intake level of 3000 mg per day by adults, except for pregnant and lactating women. This dose corresponds to ~ 2730 mg l‐threonate and 250 mg magnesium, which also corresponds to the UL for supplemental magnesium from readily dissociable magnesium salts. Based on results obtained from a dissociation study, two rat studies and one human trial, the Panel considers that magnesium is bioavailable from the NF. The NF may contain up to 1% oxalic acid. The Panel considers that an additional exposure to oxalic acid, that is up to 30 mg daily from the NF, is not to be of safety concern. The Panel concludes that the NF is not nutritionally disadvantageous. In 2008, the EFSA ANS Panel concluded that a human intake of l‐threonate of 2700 mg per day is safe. This intake is similar to the maximum intake of l‐threonate from the NF under the maximum proposed uses, and the NDA Panel concurs with the ANS Panel that this intake is safe. The Panel considers that there are no concerns regarding the genotoxicity of the NF. The Panel concludes that the NF, Mg l‐threonate, is safe under the proposed conditions of use. The Panel concludes that the NF is a source from which magnesium is bioavailable. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei plants. The principal constituents of the sap with regard to the safety assessment are chalcones (1%–2.25%) and furanocoumarins (< 0.01%). The applicant proposed to use the NF in food supplements at a maximum dose of 780 mg per day. The target population is adults excluding pregnant and lactating women. Taking into consideration the composition of the NF and the proposed uses, the composition of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90‐day oral toxicity study performed with the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins), the Panel establishes a safe dose of 0.5 mg/kg body weight (bw) per day for the product as it is intended to be placed on the market. For the target population, i.e. adults, this safe dose corresponds to 35 mg per day of the product as it is intended to be placed on the market and 137 mg per day of the NF, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of sodium bisulphate (SBS) as a feed additive for all terrestrial animal species (category: technological additive; functional group: preservative), and for all terrestrial animal species other than cats, mink, pets and other non‐food‐producing animals (category: technological additive; functional group: acidity regulator). EFSA has also been asked to assess the new use of the product as an acidity regulator and flavouring compound in all pets and other non‐food‐producing animals except aquatic animals. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all terrestrial animal species, consumer and the environment under the authorised conditions of use. The FEEDAP Panel considers that the proposed new use would not introduce risks not already considered in the previous assessment and therefore the same conclusions on all terrestrial animal species, consumers of products from animals fed the additive and the environment would apply. Regarding user safety, the additive is irritant to the skin, eyes and the respiratory tract, and should be considered a skin and respiratory sensitiser. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation. The Panel considers that the additive has the potential to be efficacious as an acidity regulator and sensory additive (flavouring compound) in feed for pet and non‐food‐producing animals (except aquatic animals). [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 Huvezym® neXo 100 G/L, a product containing endo‐1,4‐β‐xylanase, endo‐1,4‐β‐glucanase and xyloglucan‐specific‐endo‐β‐1,4‐glucanase activities produced by a non‐genetically modified strain of Trichoderma citrinoviride (DSM 33578), as a zootechnical additive for all Suidae. The applicant provided information confirming the taxonomic identification of the production strain. The batches used for the characterisation of the final formulations showed compliance with the minimum specifications of the additive in terms of enzyme activities (> 15,000 EPU, > 1000 CU, > 1000 XGU per g) but not for the ratio of the enzymes, which is lower (ca. 7:1:1) than the ones specified (15:1:1). The Panel could not conclude on the representativeness of the test item used in the toxicological and tolerance studies with respect to the final formulations. Therefore, the conclusions are limited to the product with a minimum enzyme activity of 15,000 EPU, 1000 CU, 1000 XGU per g and a xylanase:glucanase:xyloglucanase ratio of 15:1:1. The Panel concluded that the additive is safe for the target species, consumers and the environment. Huvezym® neXo 100 G is not an irritant to the skin and eyes but should be considered a skin sensitiser. Huvezym® neXo 100 L is neither an irritant to the skin and eyes nor a skin sensitiser. Due to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive has the potential to be efficacious in all reproductive Suidae at the minimum proposed use level. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for Suidae for fattening or reared for reproduction. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of microcrystalline cellulose and carboxymethyl cellulose as technological feed additives for all animal species. In its previous opinions on the safety and efficacy of the products, the FEEDAP Panel could not conclude on proper identification and characterisation as required for a feed additive. The occurrence of potential toxic impurities could also not be assessed. Based on the new data provided, the feed additives microcrystalline cellulose and carboxymethyl cellulose were properly identified and characterised and were shown to meet the specifications set for their use as food additives. Therefore, the conclusions of the safety reached in the previous opinions for microcrystalline cellulose and carboxymethyl cellulose meeting the food additive specifications apply to the microcrystalline cellulose and carboxymethyl cellulose under assessment as feed additives. The additives are considered safe for all animal species, the consumer and the environment. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety for the user. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Enterococcus lactis DSM 22502 as a technological feed additive for all animal species. The applicant provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions regarding the safety and efficacy of the additive. The FEEDAP Panel concluded that E. lactis remains safe for all animal species, consumers and environment under the authorised conditions of use. Regarding the user safety, the Panel concluded that the additive is not irritating to the skin or eyes. No conclusions can be drawn on the potential of the additive to cause skin sensitisation, but it is considered to be a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat narasin (Monteban® G100) for chickens for fattening. In a previous opinion, uncertainties remained on the identification and characterisation of the non‐genetically modified production strain of the active substance narasin. The Panel could not conclude either on the safety of Monteban® G100 for chickens for fattening or on the efficacy of the additive at the minimum applied concentration. The FEEDAP Panel excluded risks for environment but the risk for sediment compartment could not be assessed. The applicant provided supplementary information to cover the data gaps and substituted the narasin production strain from Streptomyces spp. NRRL 8092 to Streptomyces spp. NRRL B‐67771. The information submitted to taxonomically identify the production strain did not allow to assign it to any described microbial species. Based on the information provided, the Panel concluded that the use of Monteban® G100 did not raise safety concerns as regards the production strain for the target animal, consumer, user and environment. The Panel concluded that 70 mg narasin/kg complete feed was safe for chickens for fattening with a margin of safety of 1.4; narasin from Monteban® G100 was unlikely to increase shedding of Salmonella Enteritidis, Salmonella Typhimurium and Campylobacter jejuni. Narasin, when used in chickens for fattening at 70 mg/kg feed, was not expected to pose a risk to the aquatic compartment and to sediment, while a risk for the terrestrial compartment could not be excluded. No risk for groundwater was expected, nor for secondary poisoning via the terrestrial food chain, but the risk of secondary poisoning via the aquatic food chain could not be excluded. The Panel concluded that 60 mg narasin/kg feed was efficacious in controlling coccidiosis in chickens for fattening. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation regarding the maximum inclusion level of a feed additive consisting of nonanoic acid for all pigs and poultry species. Nonanoic acid is currently authorised for use as a sensory additive (functional group: flavouring compounds) for all animal species at a recommended maximum content of 5 mg/kg complete feed. The applicant is requesting a modification of the authorisation to increase the recommended maximum content of the active substance from 5 to 100 mg/kg complete feed for all poultry and pig species. In support of the safety of the additive at the new proposed level, the applicant provided tolerance trials in the target species. The FEEDAP Panel concludes that nonanoic acid is safe for all growing poultry species and Suidae at 100 mg/kg feed. The Panel cannot conclude on the safety of the new proposed level (100 mg/kg complete feed) for laying hens, turkeys for breeding, minor poultry species for laying/breeding and reproductive Suidae. However, FEEDAP Panel considered that nonanoic acid is safe at 10 mg/kg complete feed in laying hens, turkeys for breeding, minor poultry species for laying/breeding and 20 mg/kg complete feed for reproductive Suidae. The use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for the consumer and the environment. Due to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant neither a dermal nor respiratory sensitiser. No further demonstration of efficacy is necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of propyl gallate as a technological feed additive for all animal species. In its previous opinions on the safety and efficacy of the product, the FEEDAP Panel could not conclude on a safe level of propyl gallate for cats and on the safety for the consumer. Based on the new data provided, the FEEDAP Panel concluded that propyl gallate at a maximum concentration of 71 mg/kg complete feed is safe for cats. Propyl gallate is considered safe for the consumer when used in complete feed for all animal species at the concentrations considered safe for the target 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 of hydroxypropyl methyl cellulose and methyl cellulose as technological feed additives for all animal species. In its previous opinions on the safety and efficacy of the products, the FEEDAP Panel could not conclude on proper identification and characterisation as required for a feed additive. The occurrence of potential toxic impurities could also not be assessed. Based on the new data provided, the feed additives hydroxypropyl methyl cellulose and methyl cellulose were properly identified and characterised and were shown to meet the specifications set for the food additives. Therefore, the conclusions of the safety assessments reached in the previous opinions for hydroxypropyl methyl cellulose and methyl cellulose meeting the food additive specifications, apply to the hydroxypropyl methyl cellulose and methyl cellulose under assessment as feed additives. The additives are considered safe for all animal species, the consumer and the environment. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety for the user. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of ethyl cellulose as a technological feed additive for all animal species. In its previous opinions on the safety and efficacy of the product, the FEEDAP Panel could not conclude on proper identification and characterisation as required for a feed additive. The occurrence of potential toxic impurities could also not be assessed. Based on the new data provided, the feed additive ethyl cellulose was properly identified and characterised and was shown to meet the specifications set for the food additive. Therefore, the conclusions of the safety assessment reached in the previous opinions for ethyl cellulose meeting the food additive specifications, apply to the ethyl cellulose under assessment as a feed additive. The feed additive is considered safe for all animal species, the consumer and the environment. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety for the user. [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 a feed additive consisting of endo‐1,4‐β‐d‐mannanase produced by Thermothelomyces thermophilus DSM 33149, intended for use as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, turkeys for fattening, minor poultry species for fattening and ornamental birds. The safety and efficacy of the additive have been already assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the target species, consumers and the users due to lack of reliable data on the potential genotoxicity of the additive. In the present assessment, the applicant submitted a new in vitro mammalian cell micronucleus test. After the assessment of the data newly submitted, the FEEDAP Panel concluded that the use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for target species and consumer safety. The additive is not irritant to the eyes or skin. Owing to the proteinaceous nature of the active substance, the additive should be considered a respiratory sensitiser. The Panel cannot conclude on the potential of the additive to be a skin sensitiser. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of hydroxypropyl cellulose as a technological feed additive for all animal species. In its previous opinions on the safety and efficacy of the product, the FEEDAP Panel could not conclude on proper identification and characterisation as required for a feed additive. The occurrence of potential toxic impurities could also not be assessed. Based on the new data provided, the feed additive hydroxypropyl cellulose was properly identified and characterised and was shown to meet the specifications set for the food additive. Therefore, the conclusions of the safety assessment reached in the previous opinion for hydroxypropyl cellulose meeting the food additive specifications, apply to the hydroxypropyl cellulose under assessment as a feed additive. The feed additive is considered safe for all animal species, the consumer and the environment. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety for the user. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening, chickens reared for laying, other poultry species for fattening or reared for laying, and ornamental birds. The additive is available in two formulations: Lactiferm WS200 and Lactiferm Basic 50. The FEEDAP Panel concluded that the use of the additive is safe for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying, and ornamental birds. The Panel also concluded that the use of the feed additive is safe for consumers, and the environment. Lactiferm WS200 is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It was not possible, however, to conclude on the irritancy potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both formulations of the additive to cause skin sensitisation. The efficacy studies submitted did not allow to draw a conclusion on the efficacy of the additive for the target species. Lactiferm® is considered compatible with the coccidiostats monensin sodium and decoquinate. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Pediococcus pentosaceus DSM 23689 as a technological additive, silage additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers, and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation, and skin and eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a zootechnical feed additive (functional group: digestibility enhancers) for all Suidae at a recommended minimum level of 90,000 U/kg complete feed for pigs in the growing period and 45,000 U/kg complete feed for sows. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that the additive is safe at the minimum recommended use level for all growing Suidae and all sows in the lactating phase. Xygest™ HT was considered safe for the consumers and for the environment when used in feed for all Suidae. The additive was considered not to be irritant to eyes and skin, but was considered as a dermal and respiratory sensitiser. In the absence of sufficient data, the FEEDAP Panel was not in the position to conclude on the efficacy of Xygest™ HT for all Suidae. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of the additive consisting of Lentilactobacillus buchneri DSM 22501 as a technological feed additive to improve ensiling of fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not irritant to skin and eye, but owing to its proteinaceous nature it should be considered a respiratory sensitiser. No conclusions could be drawn on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on isomaltulose syrup (dried) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of a mixture of mono‐ and disaccharides in powder form, mainly composed of isomaltulose (≥ 75%) and trehalulose (< 13%). The applicant intends to use the NF as a replacement for sucrose already on the market. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. No absorption, distribution, metabolism and excretion (ADME) or toxicological data were provided for the NF. Instead, the safety of the NF was assessed based on literature data available on isomaltulose and mixtures of isomaltulose and trehalulose. In addition, considering the nature, compositional characterisation and production process of the NF, the Panel considered that such data were sufficient to conclude that the NF is as safe as sucrose. [ABSTRACT FROM AUTHOR]

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the users. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Pediococcus acidilactici CNCM I‐4622 as a zootechnical additive (functional group: physiological condition stabilisers) for all insects. The active agent used in the additive is already authorised for use in all animal species as a technological additive, and as a zootechnical additive in all Suidae species for fattening and for breeding, other than sows, all avian species, all fish species and all crustaceans. The active agent has been identified as a strain of P. acidilactici and consequently meets the qualifications required by the qualified presumption of safety (QPS) approach. The use of the additive is considered safe for all insect species, consumers and the environment. The additive is considered non‐irritant to skin and eyes but a respiratory sensitiser. No conclusions can be drawn regarding its skin sensitisation potential. In the absence of adequate data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive as a physiological condition stabiliser for honeybees nor for all insect species. [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 for the environment of the coccidiostat semduramicin sodium (Aviax 5%) when used in feed for chickens for fattening. The additive Aviax 5% is intended to be used as a coccidiostat in feed for chickens for fattening at a level of 20–25 mg semduramicin sodium/ kg complete feed. The safety and efficacy of the additive was evaluated by the FEEDAP Panel in 2018 and 2022. In those opinions it was concluded that the additive is safe for the target species and consumer, while no conclusions could be made on the irritancy of Aviax 5% to skin and eye and on the potential for dermal and respiratory sensitisation. Regarding the safety for the environment, the Panel concluded that a risk for the terrestrial compartment could not be excluded. Based on new data submitted, no risk is expected from the use of the additive in animal nutrition at the proposed conditions of use for the terrestrial compartment. The previous conclusions of the FEEDAP Panel on the safety of the additive for the environment can be updated as follows: the use of semduramicin sodium from Aviax 5% in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for groundwater nor for aquatic, terrestrial and sediment compartments. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive for weaned piglets, calves for fattening and calves for rearing. The product under assessment is based on a strain originally identified as Enterococcus faecium. During the current assessment, the active agent has been reclassified as Enterococcus lactis. The additive currently authorised is marketed in two formulations: Lactiferm Basic 50 (a solid formulation to be used in feed), and Lactiferm WS200 (a solid 'water‐soluble' formulation to be used in water for drinking). The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concludes that the use of Lactiferm® under the authorised conditions of use remains safe for the target species (calves up to 6 months and weaned piglets up to 35 kg), consumers and the environment. The Lactiferm WS200 formulation of the additive is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It is not possible to conclude on the irritating potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both forms of the additive to cause skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of folic acid as a nutritional feed additive. The additive is authorised for use in feed and water for drinking for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the safety for the terrestrial species, consumers and for the environment. The use of folic acid in aquatic animal species to cover their nutritional needs is considered safe. However, the Panel is not in a position to set a maximum safe level for all fish and crustacean species. Considering the narrow margin between the requirement and the tolerated levels seen in some aquatic animal species, the FEEDAP Panel considers that supplementation should not exceed the requirements of the different aquatic animal species. The additive is neither a skin irritant nor a dermal sensitiser. The exposure through inhalation is likely. Due to the lack of data, the FEEDAP Panel is not in the position to conclude on the potential of folic acid to be harmful to the respiratory system and irritant to eyes. The Panel retains that the previously made conclusion on the efficacy remains valid. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Levilactobacillus brevis (formerly Lactobacillus brevis) DSM 23231 as a technological feed additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that evidence has been provided that the additive currently on the market complies with the existing terms of authorisation. The Panel also concluded that L. brevis DSM 23231 remains safe for all animal species, consumers and the environment under the authorised conditions of use. The additive should be considered a respiratory sensitiser. Based on the studies submitted regarding user safety, the preparation of the additive tested was shown not to be a skin or eye irritant. The Panel was not in the position to conclude on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of copper(II)‐betaine as a nutritional additive for all animal species and on the safety for the marine sediment when the additive is used in sea cages. The FEEDAP Panel concluded that the risk to the marine sediment is acceptable when the additive is used in sea cages. The additional statistical analysis of the results of the efficacy study already assessed in the previous opinion did not allow the Panel to conclude on the efficacy of the additive. [ABSTRACT FROM AUTHOR]

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

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of natrolite–phonolite obtained from volcanic rock from Kaiserstuhl as a technological additive (functional group: anticaking) for all animal species. According to the conventional risk assessment, due to the lack of adequate data, the Panel is not in a position to conclude on the safety of the additive for the target species under the proposed conditions of use. However, from the tolerance studies in cattle for fattening and weaned piglets, effects observed in animal performance and blood clinical biochemistry suggest adverse effects on the animals supplemented with the additive. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and, therefore, of concern for the consumer. The FEEDAP Panel is not in the position to conclude on the potential of the additive to be a skin and eye irritant. The additive is considered a respiratory and dermal sensitiser. In the absence of suitable data, the presence of small/nanoparticles cannot be excluded. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles for the target species, the consumer and the user could not be assessed. Due to the lack of sufficient data, the Panel is not in a position to conclude on the efficacy of the additive. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zeolites (≥ 50%) obtained from Neapolitan Yellow Tufa as a technological additive (functional group: anticaking) for all animal species. The additive is specified to contain not less than 50% of zeolites, namely phillipsite, chabazite and analcime. Neapolitan Yellow Tufa originates from the volcanic activity of Campi Flegrei, Italy. According to the conventional risk assessment, due to a lack of adequate data, the safety of the additive for the target species cannot be established. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and, therefore, of concern for the consumer. The additive poses a risk by inhalation. It is not irritant to the skin. The Panel cannot conclude on the eye irritancy and on the dermal and respiratory sensitisation potential of the additive. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles for the target species, the consumer and the user could not be assessed. The additive is safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species at 20,000 mg/kg complete feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of benzoic acid (Kalama®) as a zootechnical feed additive for weaned piglets at a level of 5000 mg/kg complete feed and for pigs for fattening at a minimum content of 5000 mg/kg and a maximum content of 10,000 mg/kg complete feed. The FEEDAP Panel concluded that benzoic acid is safe for weaned piglets at 5000 mg/kg complete feed and for pigs for fattening at 10,000 mg/kg complete feed. The Panel considered the use of benzoic acid under the proposed conditions of use to be of no concern for consumer safety and the environment. Benzoic acid poses a risk by inhalation, it is irritant to skin and corrosive to eyes, but no conclusions can be drawn on dermal sensitisation. The additive, benzoic acid, is efficacious as a zootechnical feed additive for weaned piglets and for pigs for fattening at the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the mixture of Sepiolite and Kieselguhr (diatomaceous earth) (Anpro) as a technological feed additive for all terrestrial animal species. According to the conventional risk assessment, due to lack of adequate data, the safety of the additive Anpro for the target species cannot be established. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and therefore no concern for the consumer. The additive poses a risk by inhalation. It is not irritant to the skin or eyes but should be considered as skin sensitiser. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles could not be assessed for the target species, the consumer and the user. The additive is safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of the additive for all terrestrial animal species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of phenylcapsaicin (aXiphen®) as a zootechnical additive (functional group: physiological condition stabilisers) in feed for chickens for fattening. The additive under assessment, phenylcapsaicin, is safe for chickens for fattening up to the maximum proposed use level of 15 mg/kg complete feed. A margin of safety could not be established. Phenylcapsaicin is not genotoxic. The reference point for phenylcapsaicin derived from a 90‐day repeated dose oral toxicity study in rats is 37.2 mg/kg body weight (bw) per day, the lowest of the model averaged BMDL20 values for alanine aminotransferase increase in plasma. The metabolic similarity in the laboratory animals and the target species was not demonstrated and the identity of the marker residue could not be established. In the absence of such data, the safety for the consumers could not be evaluated. The inhalation exposure of phenylcapsaicin (as liquid) for the user was considered unlikely. The FEEDAP Panel considered the additive irritant to the eyes but not to the skin and it is not a dermal sensitiser. In the absence of appropriate data, the environmental risk assessment for phenylcapsaicin could not be performed. It is unlikely that phenylcapsaicin bioaccumulates in the environment and the risk of secondary poisoning is considered low. The FEEDAP Panel could not conclude on the efficacy of the additive in chickens for fattening at the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of Schizochytrium sp. (strain CABIO‐A‐2) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. S. sp. is a single‐cell microalga. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 38%–44% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow‐on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The evidence provided demonstrated that the strain S. sp. CABIO‐A‐2 is phylogenetically closely related to the strain S. sp. ATCC 20888. The assessment of some already authorised S. sp. oils in the Union list were also based on similarities with the strain ATCC 20888. The applicant provided a 90‐day repeated dose toxicity study in rats with the NF. No adverse effects were observed up to the highest dose tested, i.e. 10.2 g/kg body weight (bw) per day. Taking into account the toxicity studies performed with the NF and with DHA‐oils derived from strains belonging to the genus Schizochytrium, its phylogenetical profile, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of Schizochytrium sp. (TKD‐1) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single‐cell microalga. The strain TKD‐1, used by the applicant (ATK Biotech Co. Ltd.), belongs to the species Schizochytrium limacinum. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 53%–61% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow‐on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only'. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the feed additive containing Enterococcus faecium DSM 21913, Bifidobacterium animalis ssp. animalis DSM 16284 and Ligilactobacillus salivarius (formerly Lactobacillus salivarius) DSM 16351 (Biomin® C3) as a zootechnical feed additive (functional group: gut flora stabiliser) in the context of the renewal of the authorisation for chickens for fattening, chickens reared for laying and minor poultry species other than laying. In addition, the applicant requested the extension of use in all poultry species for fattening and reared for laying/breeding. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that the additive is safe for the target species, consumers and the environment under the authorised conditions of use. This conclusion also applies to the target species for which a request for an extension of use is made. The Panel concluded that Biomin® C3 is not irritant to skin or eyes but should be considered as a respiratory sensitiser due to its proteinaceous nature. No conclusions could be drawn on the skin sensitisation potential of the additive. The evaluation of the efficacy is not needed in those species for which an authorisation exists. The Panel considered that the additive is efficacious in all growing poultry species at the same inclusion level of 1 × 108 CFU/kg feed and the equivalent level in water of 5 × 107 CFU/L. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Pediococcus pentosaceus DSM 14021, a technological additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the Panel considers that any exposure through skin and respiratory tract is considered a risk. The Panel cannot conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.