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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 l‐tryptophan produced by fermentation with a non‐genetically modified strain of Escherichia coli KCCM 10534 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli KCCM 10534 is safe for the production of l‐tryptophan and it was not detected in the final product. The use of l‐tryptophan produced using E. coli KCCM 10534 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non‐ruminant target species. There may be a risk for an increased production of toxic metabolites when unprotected tryptophan is used in ruminants. The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of l‐tryptophan via water for drinking and feed due to possible amino acid imbalances. The use of l‐Tryptophan produced by E. coli KCCM 10534 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. The additive under assessment is considered not toxic by inhalation, it is not a skin or eye irritant and is not a skin sensitiser. The endotoxin activity of the additive and its dusting potential indicate a risk by inhalation for the users. The product l‐tryptophan is regarded as an effective source of the amino acid l‐tryptophan 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, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy Nimicoat® (carvacrol), as a zootechnical additive for weaned piglets. The additive is composed by carvacrol (≥ 40 %) as an active substance encapsulated with high‐melting lipids. Nimicoat® is intended to be used in feed for weaned piglets at a minimum recommended dose of 250 mg/kg complete feed and at a maximum recommended dose of 1,000 mg/kg complete feed corresponding to a minimum and maximum of 100 and 400 mg carvacrol/kg complete feed, respectively. Based on a tolerance study, the FEEDAP Panel concluded that the use of Nimicoat® in feed for weaned piglet at the maximum recommended dose of 1,000 mg/kg feed is safe for the target animal; however, a precise figure for the margin of safety cannot be defined. Nimicoat® used in feed for weaned piglets at the maximum recommended concentration does not pose a safety concern for consumers. The additive is corrosive to eyes, skin and the respiratory mucosae. Concerning safety for the environment a Phase II was required; taking into consideration the data provided, the FEEDAP Panel concluded that the additive does not pose any risk to the terrestrial and aquatic compartments and that bioaccumulation potential for carvacrol is low and risk for secondary poisoning for worm/fish eating birds and mammals is not likely to occur. Only one study positively supporting efficacy of the additive was available; therefore, the FEEDAP Panel is not in a position to conclude on the efficacy of Nimicoat®. [ABSTRACT FROM AUTHOR]

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

The feed additive 'dry grape extract 60‐20' is a mixture of two extracts, one from the seed and the other from the skin of Vitis vinifera subsp. vinifera. It is intended to be used as a sensory additive (functional group: flavouring compound) in dogs. The additive 'dry grape extract 60‐20' is specified to contain ■■■■■ The applicant proposes a maximum use level of 100 mg 'dry grape extract 60‐20'/kg of complete feedingstuffs for dogs without a withdrawal period. The FEEDAP Panel was aware of case reports indicating acute toxicity for some dogs consuming grapes or raisins at exposure levels relevant to the use of 'dry grape extract 60‐20'. The FEEDAP Panel considered that rare idiosyncratic effects could be possibly responsible for the reported cases of fatality in dogs due to acute renal failure following exposure to different types of grapes. The FEEDAP Panel considered that the additive is poorly characterised. Based on the data available, the FEEDAP Panel was not able to conclude on the safety of 'dry grape extract 60‐20' when used as a feed additive for dogs. In the absence of studies to assess the safety for the user, the FEEDAP Panel could not conclude on the safety for the user when handling the additives. Since grape seed extract is used in food as flavouring, and its function in feed is essentially the same as that in food no further demonstration of efficacy was necessary. [ABSTRACT FROM AUTHOR]

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

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

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

AviPlus® is an additive containing a mixture of sorbic acid, citric acid, thymol and vanillin. The applicant requested for the renewal of the authorisation for AviPlus® when used as a feed additive in all porcine species (weaned), chickens for fattening, chickens reared for laying, minor poultry species for fattening, minor poultry species reared for laying. 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 AviPlus® under the current authorized conditions of use is safe for the target species, the consumers, the users and the environment. 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 assessment of the application for renewal of authorisation of AveMix®XG 10 (endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase) for chickens for fattening. 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 the target species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not considered to be a dermal or eye irritant but it is a dermal and 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, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐isoleucine produced by Escherichia coli FERM ABP‐10641 (i) to renew the authorisation and to extend the use of the additive in water for drinking when used as a nutritional additive for all animal species and (ii) to evaluate a new use as a flavouring additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. l‐Isoleucine does not give rise to any safety concern regarding the production strain and its genetic modification. Considering that the production process has not been substantially modified and that no adverse effects have been reported in the literature search, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in previous assessments. Therefore, the Panel considers that the additive l‐isoleucine produced by E. coli FERM ABP‐10641 remains safe for the target species, consumer and for the environment when used as a nutritional additive in feed. The Panel extends these conclusions to the use of the additive as a flavouring compound. Regarding the use in water, the FEEDAP Panel 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. l‐Isoleucine is not irritant to skin and eyes and is not a dermal sensitiser but is hazardous by inhalation. The Panel confirms the previous conclusions that the additive is considered as a source of available isoleucine for non‐ruminant animal species when used as a nutritional additive. It requires protection against degradation in the rumen to be as efficacious in ruminants as in non‐ruminant species. The Panel considers the use of the additive in water for drinking to be equally effective than the use in feed when used as a nutritional additive. Since l‐isoleucine is used in food as a flavouring compound, and its function in feed is essentially the same as that in food no further demonstration of efficacy is necessary. [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‐cystine produced using Pantoea ananatis NITE BP‐02525 when used as a nutritional additive (amino acid) or as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. l‐Cystine is a dispensable sulfur‐containing amino acid, naturally occurring in proteins of plants and animals. The amino acid l‐cystine produced by fermentation with P. ananatis NITE BP‐02525 is safe for all animal species, if the requirements for sulfur‐containing amino acids are respected. The maximum amount of l‐cystine that can be safely added to the diet will depend on the levels of other sulfur amino acids. This conclusion would also cover its use as a sensory additive. The use of l‐cystine produced by fermentation with P. ananatis NITE BP‐02525 in animal nutrition raises no safety concerns to consumers of animal products. The additive under assessment is considered slightly irritating by inhalation, not irritating to the skin or eyes and is not a skin sensitiser. There is no risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of the l‐cystine produced by fermentation with P. ananatis NITE BP‐02525 as a feed additive does not represent a risk to the environment. l‐Cystine is considered efficacious in partially meeting the requirements of sulfur‐containing amino acids in all animal species. For the supplemental l‐cystine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. It is also considered efficacious as a feed flavouring compound under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

The additive is a natural mixture mainly composed of illite (~ 53%), montmorillonite (~ 16%) and kaolinite (~ 17%), referred as MIMK. In 2016 and in 2017, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered two opinions on the safety and efficacy of the additive. In these opinions, the Panel concluded that the additive is safe for piglets, pigs for fattening and cattle for fattening and minor growing ruminants at a maximum concentration of 50,000 mg/kg. No conclusions could be drawn on the safety for poultry or any other species/categories. Following these opinions, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species. The applicant submitted a new tolerance study with chickens for fattening showing no adverse effect of the additive MIMK up to 100,000 mg/kg complete feed (twofold the highest recommended use level). The FEEDAP Panel therefore concludes that 50,000 mg MIMK/kg complete feed is safe for chickens for fattening. MIMK was already considered safe, at the same dietary concentration, for cattle for fattening with a margin of safety of two and for piglets but without a margin of safety. Therefore, extrapolation to all animal species is not possible for the concentration of 50,000 mg MIMK/kg complete feed. The Panel notes that the concentration of 20,000 mg MIMK/kg feed was tested in all the tolerance studies assessed and shown to be safe, with a margin of safety of at least 2.5. The Panel concludes that the additive MIMK is safe at 50,000 mg/kg complete feed for chickens for fattening and minor growing poultry species, for cattle for fattening and minor growing ruminant species and growing pigs; and at 20,000 mg/kg complete feed for all other animal species and categories. [ABSTRACT FROM AUTHOR]

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 (selenised yeast inactivated) (Sel-Plex®) for all animal species. In 2006, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive; subsequently it was authorised in the EU. The evidence provided indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. In particular, the Panel confirms that the use of Sel-Plex® in animal nutrition does not pose a risk to consumers provided that the maximum selenium supplementation of 0.2 mg/kg feed from Sel-Plex® is not exceeded, yet respecting the maximum total selenium in feed of 0.5 mg/kg. In the context of the current application, the Panel reviewed toxicological studies; based on two repeated-dose studies on rats and dogs, it is concluded that the toxic potential of Sel-Plex® is only related to its selenium content. New data on characterisation of the additive and studies on effects on skin and eyes led the Panel reconsider the safety for the user. The Panel concluded that the additive is hazardous upon inhalation and a likely respiratory sensitiser; owing to the high dusting potential, persons handling the additive are at risk by inhalation. It is considered not irritant to the eyes and skin. A recommendation regarding the denomination of the additive under assessment was proposed by the Panel. [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 additional data submitted for ethyl ester of β‐apo‐8‐carotenic acid (β‐apo‐8‐ester) when used as a feed additive for poultry for fattening and poultry for laying. The proposed maximum content for β‐apo‐8‐ester of 40 mg/kg complete feed is safe for laying hens with a margin of safety of at least two. The following dietary concentrations are considered safe for the adult consumers, including the age classes adults, elderly and very elderly: 15 mg β‐apo‐8‐ester/kg complete feed for chickens for fattening, 5 mg β‐apo‐8‐ester/kg complete feed for laying hens and 40 mg β‐apo‐8‐ester/kg complete feed for laying hens only intended to the production of liquid eggs which will be only used by the pasta industry for the production of egg pasta. Concerns would arise for the age classes infants, toddlers, other children and adolescents in those countries where dietary surveys showed higher consumption of egg and egg‐derived products (Bulgaria, Spain, the UK, the Netherlands, Greece, the Czech Republic and Italy) and higher consumption of egg pasta (Bulgaria, Spain, the UK, the Netherlands, Germany, Denmark, Greece, Austria, the Czech Republic, France, Latvia, Sweden and Italy) assuming that the egg pasta is manufactured with liquid eggs from laying hens treated with 40 mg β‐apo‐8‐ester/kg 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 a tincture from Verbascum thapsus L. (great mullein tincture) when used as a sensory feed additive for all animal species. The product is a water/ethanol (■■■■■) solution, with a dry matter content of approximately 2.8%. The product contains on average 0.216% polyphenols and 0.093% flavonoids. Since 82% of the dry matter fraction of the additive remains uncharacterised, the FEEDAP Panel cannot identify a safe level for the use of the additive for all animal species. Considering the uncertainty in the composition of the additive, and in the absence of information on the toxicological properties of the tincture, the FEEDAP Panel is unable to conclude on the safety for the consumers following the use of the tincture as flavouring in animal feed. No specific data were provided by the applicant regarding the safety of the additive for users. In the absence of data, no conclusions can be drawn on the additive's potential to be a dermal/eye irritant or a skin sensitiser. V. thapsus L. is native to Europe. Consequently, the use of a tincture derived from the plant at the maximum proposed dose is not considered to be a risk for the environment. Since the major components of the additive are recognised to provide flavour in food and its function in feed would be essentially the same, no demonstration of efficacy is considered necessary. [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 an essential oil extracted from Origanum vulgare ssp. hirtum (Link) Ietsw. when used as a sensory feed additive for all animal species. Analysis of the oil identified 13 components accounting for > 99% of the oil, with carvacrol being the prevalent (78%). The FEEDAP Panel concludes that the proposed use level of 150 mg/kg complete feed is safe for ornamental fish. For the other species, the calculated maximum safe concentration of the essential oil in complete feed was 22 mg/kg for chickens for fattening, 33 mg/kg for laying hens, 30 mg/kg for turkeys for fattening, 40 mg/kg for piglets, 48 mg/kg for pigs for fattening, 63 mg/kg for sows, 57 mg/kg for dairy cows, 100 mg/kg for veal calves, 88 mg/kg for cattle for fattening, sheep, goats and horses, 35 mg/kg for rabbits, 101 mg/kg for salmonids, 106 mg/kg for dogs, and 18 mg/kg for cats. No concerns for consumer safety were identified following the use of the additive up to the maximum safe concentration in feed. The additive is considered as irritant to skin and eyes and a potential skin and respiratory sensitiser. Use in animal husbandry of the essential oil extracted from O. vulgare ssp. hirtum is not expected to pose a risk for the environment. Since oregano and its preparations are recognised to flavour food and their function in feed would be essentially the same, no further demonstration of efficacy is considered necessary for the essential oil. [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 astaxanthin‐dimethyldisuccinate (ATX‐DMDS) for salmonids, crustaceans and other fish. The applicant has provided evidence that ATX‐DMDS currently on the market complies with the conditions of authorisation for salmon and trout. ATX and ATX‐DMDS are safe for salmonids, crustaceans and fish up to 100 mg ATX/kg complete diet, corresponding to 138 mg ATX‐DMDS/kg. The FEEDAP Panel re‐assessed the toxicological profile of ATX based on data already considered in 2014, the literature review performed by the applicant and the data available in the context of an EFSA public call for data on ATX. The acceptable daily intake (ADI) of 0.2 mg astaxanthin/kg body weight (bw) per day obtained by applying an uncertainty factor of 200 to a lowest observed adverse effect level (LOAEL) of 40 mg/kg bw per day for the increased incidence of multinucleated hepatocytes observed in a 2‐year carcinogenicity study replaces the one of 0.034 mg/kg bw established by the FEEDAP Panel in 2014. The use of ATX‐DMDS in the nutrition of salmonids, other fish and crustaceans up to the maximum permitted dietary level is of no concern for the safety of the consumer. No dermal or ocular risk for the users is likely to occur under practical conditions. In the absence of inhalation toxicology study, the Panel is not in the position to establish the inhalation toxicity of the additive. The use of synthetic ATX‐DMDS does not pose a significant additional risk to the environment compared with natural astaxanthin. ATX‐DMDS is efficacious in colouring the flesh of salmonids and other fish. ATX‐DMDS is an effective pigment for crustaceans at the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Yea‐Sacc® is an additive based on a live preparation of a strain of Saccharomyces cerevisiae intended for use as a zootechnical additive (digestibility enhancer). The current assessment is performed in the context of the renewal of the authorisation of the feed additive; however, the applicant proposed also to lower (6.5 × 108 colony forming unit (CFU)/kg of complete feedingstuff) the minimum dose of the additive when used in feed for horses. The additive is produced in a powder (Yea‐Sacc®) and in a prills (Yea‐Sacc®_TS) forms. The Panel considered that the additive currently on the market complies with the existing conditions of authorisation. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the production strain has been confirmed, safety for the target species, consumer and the environment were presumed. Both formulations are non‐irritant to skin, Yea‐Sacc®_TS is non‐irritant to the eye while Yea‐Sacc® is a moderate irritant. Both formulations should be considered skin sensitisers and because of their high proteinaceous nature, they should be considered as potential respiratory sensitisers. The applicant submitted two efficacy studies: the FEEDAP Panel concluded that in the first study inconsistent results were observed for the two lower doses which are considered microbiologically equivalent. The second study demonstrated that Yea‐Sacc® at the level of 7.5 × 108 resulted in a better digestion of organic matter which may be explained by increases in digestibility of the fibre. Based on the data provided, the FEEDAP Panel cannot conclude on the efficacy of Yea‐sacc® when used as a feed additive in horses at the proposed level (6.5 × 108CFU/kg complete feed). [ABSTRACT FROM AUTHOR]

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of l‐methionine produced by fermentation with Corynebacterium glutamicum KCCM 80184 and Escherichia coli KCCM 80096 for all animal species. The two producing microorganisms were obtained by genetic modification. l‐Methionine is intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains, nor their recombinant DNA were detected in the final product. The additive does not pose any safety concern associated with the genetic modification of the production strains. l‐methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096. The additive is considered safe for the target species, for the consumer and for the environment. l‐Methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096 is considered not toxic by inhalation, non‐irritant to skin or eyes and not a dermal sensitiser. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety of l‐methionine for target species when administered via water for drinking owing to the risk of nutritional imbalances and hygienic reasons. l‐Methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096 is considered as an efficacious source of the essential amino acid l‐methionine for non‐ruminant animal species. For the supplemental l‐methionine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. [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 lactic acid and calcium lactate for all animal species. In 2015 and in 2017, the Panel on Additives and Products or Substances used in Animal Nutrition (FEEDAP) delivered two opinions on the safety of lactic acid and calcium lactate. In that opinion, the panel concluded that the additive is safe for pigs and ruminants at concentrations of 50,000 mg lactic acid/kg complete feed but could not conclude on the safety for poultry and for pre‐ruminants. Now the applicant is proposing a new maximum concentration of 20,000 mg lactic acid/kg feed for all other animal species, with the exclusion of pre‐ruminants, and provided a new study in chickens for fattening. Based on the results of the new study, the Panel concluded that 20,000 mg lactic acid/kg complete feed is safe for chickens for fattening. The FEEDAP Panel extrapolates the lowest safe level of 20,000 mg lactic acid/kg complete feed observed in chicken for fattening to all animal species other than pigs and ruminants for which 50,000 mg lactic acid/kg is safe, with the exception of pre‐ruminants for which a safe dose could not be established. The maximum content of 20,000 mg lactic acid is equivalent to 24,000 mg calcium lactate and 30,000 mg calcium lactate hydrate (hydrate, n = 4–5). The corresponding maximum content in water for drinking would be 8,000 mg lactic acid/L. [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 butylated hydroxy anisole (BHA) for all animal species. In 2018, the Panel delivered an Opinion on the safety and efficacy of BHA. The Panel concluded that 'a weight of evidence of the limited data supports that 150 mg BHA/kg complete feed would be a safe dose for all animal species. However, a possible exception could be cat, with its known lower capacity for glucuronidation of phenolic compounds and for which no specific data were available'. The Applicant submitted a review of the metabolism of phenolic compounds in cats and an in vivo study with cats. No specific information on metabolic fate of BHA has been made available for the feline species. The lack of knowledge is of particular relevance considering the additional load of phenolic compounds by dietary BHA for the full lifetime expectancy of cats. Owing the shortcomings in the design and reporting, the in vivo study could not be used to conclude on the safety of BHA for cats. Consequently, the Panel reiterates that no safe concentration of BHA in complete feed for cats could be established. [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 additional data submitted on Lancer® when used as a feed additive for weaned piglets. The FEEDAP Panel considered that uncertainty still remains on possible developmental neurotoxicity of Lancer® since it was unable to identify a no observed adverse effect level (NOAEL) for this specific endpoint applying a read‐across strategy from the studies provided by the applicant. However, the FEEDAP Panel considered that the exposure to La and Ce from products of animals treated with Lancer® at 250 mg/kg feed would not add a significant contribution to the background exposure of these elements. The FEEDAP Panel concluded that the use of Lancer® in feed for weaned piglets (up to 120 days) according to the proposed conditions of use, does not represent a safety concern for the consumer and for the environment. [ABSTRACT FROM AUTHOR]

The feed additive Elancoban® G200, containing the active substance monensin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening, chickens reared for laying and turkeys. The FEEDAP Panel cannot conclude on the safety of the additive for the target species, consumer, user and environment with regard to the safety of the production strain. The following conclusions apply to monensin sodium included in the additive. Based on the available data set, the FEEDAP Panel cannot conclude on the safety of Elancoban® G200 for chickens for fattening. Monensin sodium is safe for turkeys for fattening with a margin of safety of 1.5. Monensin sodium is not genotoxic and not carcinogenic. The pharmacological no observed adverse effect level (NOAEL) of 0.345 mg monensin sodium/kg body weight (bw) per day was identified in dog. The acceptable daily intake (ADI) derived from this NOAEL is 0.003 mg monensin sodium/kg bw applying an uncertainty factor of 100. Elancoban® G200 is safe for the consumer. The existing maximum residue limits (MRLs) ensure consumer safety, provided that the withdrawal period of 1 day is respected. Elancoban® G200 is very irritant for the eye, but it is not a skin irritant. Elancoban® G200 should be regarded as a potential skin and respiratory sensitiser. Inhalation exposure is considered a risk to persons handling the additive. Elancoban® G200 does not pose a risk for the terrestrial compartment, the aquatic compartment and the sediment. The bioaccumulation potential of monensin in the environment is low. Monensin sodium from Elancoban® G200 has the potential to effectively control coccidiosis in chickens for fattening and chickens reared for laying. The FEEDAP Panel cannot conclude on the efficacy Elancoban® G200 as a coccidiostat for turkeys for fattening. [ABSTRACT FROM AUTHOR]

RONOZYME®WX is an additive that contains endo‐1,4‐β‐xylanase which is authorised for use as a feed additive in poultry for fattening, weaned piglets and pigs for fattening. The Panel on additives and Products or Substances used in Animal Feed (FEEDAP) delivered in 2012 an opinion on the safety and efficacy of RONOZYME®WX when used as a feed additive for poultry, piglets (weaned) and pigs for fattening and another one in 2016 on the change of the production strain proposed by the applicant. In those opinions, the FEEDAP Panel concluded that the use of the product as a feed additive raise no concerns for consumer safety or for the environment. Considering the safety for the user, the Panel concluded that the additive is not a skin or eye irritant but could not conclude on the skin sensitisation potential of the additive, however, and owing to the proteinaceous nature of the active substance the additive was considered a potential respiratory sensitiser. In a further application, the applicant requested the use of the additive in laying hens. The tolerance trial provided for that assessment allowed to conclude that the additive is safe for laying hens under the recommended conditions of use. In the same application and in order to support the efficacy of the additive in laying hens, the applicant submitted three long‐term trials. In all three trials, the groups receiving the xylanase at the recommended dose showed a lower feed intake and a better feed to egg mass ratio. However, in one of the three trials, these reductions were seen concurrently with a decrease in the laying rate. This result casted doubts on the efficacy of the additive, and therefore, the Panel considered that there was not sufficient evidence to conclude on the efficacy of the product. The applicant provided a further efficacy trial in which the results showed that the hens that received the additive had a better laying performance at the recommended level of 100 FXU/kg and allowed the Panel to conclude that the additive is efficacious as a zootechnical additive in 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 safety and efficacy of Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets and for all porcine species. This additive contains endo‐1,4‐β‐xylanase produced by a genetically modified strain of Bacillus subtilis and it is authorised in the European Union as a feed additive for poultry for fattening, weaned piglets and pigs for fattening. The applicant requested the extension of use of the additive to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of Belfeed B MP/ML in all Suidae species. The additive is not irritant for skin or eye but it should be considered a potential respiratory sensitiser for the users, the Panel could not conclude on the potential of the additive as a potential dermal sensitiser. Considering the results from a tolerance trial done in weaned piglets, those in a subchronic oral toxicity study and the nature/origin of the product under assessment the Panel concluded that the additive is safe for all porcine species at any developmental stage. The data previously assessed in piglets and pigs for fattening allowed to conclude that the additive is efficacious at 10 IU/kg feed in suckling piglets and all Suidae species from suckling to slaughter. The data submitted to support the efficacy for sows was considered insufficient and therefore the Panel could not conclude on the efficacy in sows. [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 CI‐FER™ (ferric citrate chelate) as zootechnical feed additive for suckling and weaned piglets and minor porcine species. The additive is safe for weaned piglets at the recommended level of 500 mg/kg complete feed. This conclusion can be extended to sucking piglets for the period in which solid feed is given and extrapolated to all minor porcine species. No concerns for consumer safety are expected from the use of the additive in piglets and minor porcine species. The FEEDAP Panel considers that the compound under assessment poses a risk to users by inhalation. The product should also be considered as an irritant to skin, eyes and mucous membranes. Due to the presence of nickel, CI‐FER™ should also be considered as a dermal and respiratory sensitiser. The supplementation of feed with the additive is not expected to pose an environmental risk. CI‐FER™ used at the minimum recommended level of 500 mg/kg feed has the potential to improve zootechnical parameters of weaned piglets. This conclusion can be extended to sucking piglets for the period in which solid feed is given and extrapolated to all minor porcine species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the product Biosprint® (Saccharomyces cerevisiae MUCL 39885) as a feed additive for dairy cows and horses. S. cerevisiae is considered by EFSA to have qualified presumption of safety (QPS) status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel confirms that the use of Biosprint® under the current authorised conditions of use is safe for the target species, the consumers and the environment. The additive is considered as a potential skin and eye irritant and skin/respiratory sensitiser. There is no need to assess the efficacy of Biosprint® 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 feed additive for piglets and growing minor porcine 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 an application for its use in feed for chickens for fattening. The Panel concluded in that opinion 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 that should be considered as a respiratory sensitiser. The Panel considered that the new use in piglets would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial and a subchronic oral toxicity study were made available to support the safety for the new target species. From the results obtained, the Panel concluded that the additive is safe for piglets (suckling and weaned) and for growing minor porcine species at the recommended enzyme activity of 250 U/kg feed with a wide margin of safety. The applicant submitted three efficacy trials to support the efficacy of the additive. In the trials, the apparent faecal digestibility of phosphorus and bone ash/phosphorus content were measured. From the results obtained, the FEEDAP Panel concluded that APSA PHYTAFEED®GR/L is efficacious for piglets (suckling and weaned) and for growing minor porcine species at an enzyme activity of 1,000 U/kg 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 EB15 10 for all pigs. The additive is a preparation containing viable spores of a strain of Bacillus subtilis intended for use in feed at the proposed dose of 5 × 108 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108CFU/L. The additive exists in two forms, EB15 and EB15 10, and has been previously characterised by the FEEDAP Panel. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements, and consequently, the additive was presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. The data made available by the applicant allowed the Panel to conclude that the additive in either form has a potential to be efficacious as a zootechnical additive when added to feed for piglets (suckling and weaned), pigs for fattening and sows (excluding a benefit from sows to suckling piglets) at 5 × 108 CFU/kg (corresponding to 1.7 × 108 CFU/L water) The conclusions on the efficacy were extrapolated to all Suidae species. [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 safety for the environment of the proposed modification of the terms of the authorisation regarding the formulation of the additive Lactococcus lactis NCIMB 30160. The applicant has proposed to modify the manufacturing process by adding polyethylene glycol (PEG 4000) in the list of potential cryoprotectants that can be used in the freeze‐drying step, up to a maximum concentration of 0.025 mg PEG 4000/kg silage. The use of PEG 4000 as an excipient in formulations with Lactococcus lactis NCIMB 30160 would not change the previous conclusions regarding the safety for the target animals, consumers and users. No safety concerns are expected for the environment when PEG 4000 is used as a cryoprotectant in the additive Lactococcus lactis NCIMB 30160 up to a maximum concentration of 0.025 mg PEG 4000/kg silage. [ABSTRACT FROM AUTHOR]

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

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 feed additive turkeys for fattening, turkeys reared for breeding and minor poultry 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 an application for its use in feed for chickens for fattening. The Panel concluded in that opinion 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 that should be considered as a respiratory sensitiser. The Panel considered that the new use in turkeys would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial and a subchronic oral toxicity study were made available to support the safety for the new target species. From the results obtained, the FEEDAP Panel concluded that APSA PHYTAFEED®GR/L is safe for turkeys for fattening at the recommended level of 250 U/kg feed with a wide margin of safety. This conclusion was extended to turkeys reared for breeding. The applicant submitted three efficacy trials to support the efficacy of the additive. In these trials, the utilisation of phosphorus and bone ash/phosphorus content were measured. From the results obtained, the FEEDAP Panel concluded that APSA PHYTAFEED®GR/L is efficacious for turkeys for fattening, turkeys reared for breeding and minor poultry at the level of 250 U/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 Panel) was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat Monimax® (monensin sodium and nicarbazin) when used in feed for turkeys or chickens for fattening. In previous assessments (2017, 2018), the FEEDAP Panel could not conclude on the safety of Monimax® for the environment due to concerns on monensin sodium and 4,4′‐dinitrocarbanilide (DNC, one of the moieties of nicarbazin). The applicant provided additional information that has been assessed. The use of monensin sodium from Monimax® in complete feed for chickens for fattening, chickens reared for laying and turkeys for fattening poses no risk for the aquatic compartment, the terrestrial compartment or for sediment. The bioaccumulation potential of monensin in the environment is low. No concerns would arise for the 4,6‐dimethylpyrimidin‐2‐ol (HDP) moiety of nicarbazin excreted from chickens for fattening, chickens reared for laying and turkeys fed Monimax®. The use of DNC moiety of nicarbazin from Monimax® in complete feed for chickens for fattening, chickens reared for laying and turkeys for fattening poses no risk for the aquatic compartment, the terrestrial compartments or for sediment. The bioaccumulation potential of DNC in the environment is low and the risk for secondary poisoning is not likely to occur [ABSTRACT FROM AUTHOR]

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by genetically modified strains of Corynebacterium glutamicum (NRRL‐B‐67439 or NRRL B‐67535). They are intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains C. glutamicum strains NRRLB‐67439 or NRRL B‐67535; nor their recombinant DNA were detected in the final products. Therefore, those products do not pose any safety concern associated with the genetic modification of the production strains. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l‐lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535. Concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535, due to its high pH (10.7 and 10.9, respectively) is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered as efficacious sources 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 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 ZM16 10 for all pigs. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens intended for use in feed at the proposed dose of 5 × 108 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108 CFU/L. The additive exists in two forms, ZM16 and ZM16 10, and has been previously characterised by the FEEDAP Panel. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements and consequently, the additive was presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. The data made available by the applicant allowed the Panel to conclude that the additive, in either form, has a potential to be efficacious as a zootechnical additive when added to feed for piglets (suckling and weaned), pigs for fattening and sows at 5 × 108 CFU/kg (corresponding to 1.7 × 108 CFU/L). The conclusions on the efficacy were extrapolated to all Suidae 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 efficacy of EB15 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus subtilis (DSM 25841). This product is available in two forms, EB15 and EB15 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010CFU/g additive, respectively. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in weaned piglets. The Panel concluded that the active agent fulfils the requirements of the qualified presumption of safety (QPS) approach to the assessment of safety. Consequently, the additive is presumed safe for the target animals, consumers of products from animals fed with the additive and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a potential respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive was not sufficient to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species. The applicant provided supplementary information to complement the data, including a statistical analysis pooling data from different studies. Based on the newly submitted data, the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in weaned piglets at a level of 5 × 108CFU/kg complete feed or in water for drinking at 1.7 × 108CFU/L. This conclusion was extrapolated to minor porcine species at the same developmental stage. [ABSTRACT FROM AUTHOR]

ECONASE®XT is an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei ■■■■■. The additive is currently authorised for use in chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. This scientific opinion concerns the renewal of the authorisation of the additive when used in weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. ECONASE®XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. The current application also comprises three new less concentrated formulations. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches. However, since no sequences of concern have been introduced in the production strain, the potential presence of recombinant DNA in the final product does not raise any safety concern. No new evidence has been produced that would lead the Panel to reconsider its previous conclusions on the safety of the product for target species, consumers, users and the environment under the authorised conditions of use. Therefore, the FEEDAP Panel confirms that ECONASE®XT is safe for the target species, consumers of products from animals fed the additive and the environment. ECONASE®XT is non‐irritant to the skin, the liquid form is non‐irritant to the eyes and is not a dermal sensitiser, but the additive in all forms should be considered a potential 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, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of ZM16 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens (DSM 25840). This product is available in two forms, ZM16 and ZM16 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010CFU/g additive, respectively. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in weaned piglets. The Panel concluded that the active agent fulfils the requirements of the qualified presumption of safety (QPS) approach to the assessment of safety. Consequently, the additive is presumed safe for the target animals, consumers of products from animals fed with the additive and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a potential respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive was not sufficient to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species. The applicant provided supplementary information to complement the data, including a statistical analysis pooling data from different studies. Based on the newly submitted data, the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in weaned piglets at a level of 5 × 108CFU/kg complete feed or in water for drinking at 1.7 × 108CFU/L. This conclusion was extrapolated to minor porcine species at the same developmental stage. [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 a tincture from Artemisia vulgaris L. (Mugwort tincture) when used as a sensory feed additive for all animal species. The product is a water/ethanol ■■■■■ solution, with a dry matter content of approximately 1.7%. The product is specified to contain a minimum of 0.01% hydroxycinnamic acid derivatives (expressed as chlorogenic acid). However, since the 74% of the dry matter fraction of the additive remains uncharacterised, the FEEDAP Panel cannot 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. No specific data were provided by the applicant regarding the safety of the additive for users. In the absence of data, no conclusions can be drawn on the additive's potential to be a dermal/eye irritant or a skin sensitiser. A. vulgaris is native to Europe. Consequently, the use of a tincture derived from the plant at the maximum proposed dose is not considered to be a risk for the environment. Since the major components of the additive are recognised to provide flavour in food and its function in feed would be essentially the same, no demonstration of efficacy is considered necessary. [ABSTRACT FROM AUTHOR]

Following the 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 proposed modification of the terms of the authorisation regarding the maximum inclusion level of Maxiban® G160. The FEEDAP Panel cannot conclude on the safety of Maxiban® G160 at a dose level of 70 + 70 mg/kg feed for the target species. The use of Maxiban® G160 in diets for chickens for fattening at the maximum proposed dose complies with the maximum residue levels (MRLs) in force of narasin and 4,4'‐dinitrocarbanilide (DNC) at 0‐day withdrawal except for DNC in kidney which was slightly above the MRL. Compliance with DNC MRLs was seen in all tissues at 1‐day withdrawal. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Maxiban® G160 for the environment due to the risk identified for the terrestrial organisms due to DNC. Moreover, the high persistence and hydrophobicity of DNC indicate that there might be a risk for bioaccumulation but the risk for secondary poisoning was not identified. The potential of DNC to accumulate in soil over the years should be investigated by monitoring in a field study. The FEEDAP Panel would not be in the position to conclude on the efficacy of Maxiban® G160 in chickens for fattening based on the data provided for the dose of 40 + 40 mg narasin + nicarbazin/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 Bacillus licheniformis DSM 32457 as a silage additive for all animal species. Bacillus licheniformis DSM 32457 is presumed safe for the target species, consumers of products from animals fed treated silage and 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 potential respiratory sensitiser. In the absence of appropriate data, the FEEDAP Panel cannot conclude on the efficacy of Bacillus licheniformis DSM 32457 as a silage additive. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 3‐phytase FLF1000 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 the European Union as a feed additive for feed 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 applicant requested the extension of use of the additive to pigs for fattening and minor porcine species for growing. The FEEDAP Panel concluded that the use of the product as a feed additive for pigs raises no concerns for the consumer safety nor for the environment. The additive should be regarded as a potential respiratory sensitiser. The applicant provided a combined tolerance and efficacy trial in weaned piglets to support the safety for the target species. However, owing to the lack of precise data on the total feed intake of the animals, the FEEDAP Panel did not consider further the study for the assessment and consequently no conclusion could be drawn regarding the safety of the additive for pigs for fattening nor for other minor growing porcine species. Three studies were considered for the efficacy and from the data obtained the FEEDAP Panel concluded that the additive has the potential to be efficacious in improving the phosphorus utilisation in pigs for fattening at a minimum level of 500 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 the safety and efficacy of RONOZYME®WX CT/L as a feed additive for sows for reproduction. This additive contains endo‐1,4‐β‐xylanase produced by a genetically modified strain of Aspergillus oryzae and it is authorised in the EU as a feed additive for poultry for fattening, weaned piglets and pigs for fattening. The applicant requests the extension of use of the additive to sows for reproduction at 200 FXU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of RONOZYME®WX in sows. The FEEDAP Panel concluded that the additive is not a skin or eye irritant, but it should be considered a respiratory sensitiser, but could not conclude on the skin sensitisation potential of the additive. A tolerance trial in lactating sows and two toxicological studies were made available to support the safety of the target species. Based on the data available, the FEEDAP Panel concluded that the additive is safe for sows for reproduction at the recommended level with a wide margin of safety. Three efficacy studies in lactating sows were evaluated. Sows that received RONOZYME®WX showed improvements on the apparent faecal digestibility of the energy in the three trials. The enzyme activity in feed that showed efficacy ranged from 124 to 287 FXU/kg feed, and the FEEDAP Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in lactating sows at a level of approximately 250 FXU/kg feed. No data has been provided in gestating sows, and consequently, the Panel could not conclude on this physiological stage of the productive cycle. [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 monohydrate produced by fermentation with Escherichia coli (NITE BP‐02526) when used as a nutritional additive or as a feed flavouring compound in feed and water for drinking for all animal species. The product under assessment is l‐histidine HCl H2O produced by fermentation with a genetically modified strain of E. coli (NITE BP‐02526). The production strain and its recombinant DNA were not detected in the final products. l‐Histidine HCl H2O does not give rise to any safety concern to the production strain. The use of l‐histidine HCl H2O is safe for the target species when used to supplement the diet in appropriate amounts. It is safe at the proposed use level of 25 mg/kg when used as a flavouring compound for all animal species. The use of l‐histidine HCl H2O in animal nutrition raises no safety concerns for consumers of animal products. The additive is not irritating to the skin or eyes and is not a skin sensitiser. There is a risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of l‐histidine as a feed additive does not represent a risk to the environment. The additive l‐histidine HCl H2O is regarded as an effective source of the amino acid l‐histidine when used as a nutritional additive. For the supplemental l‐histidine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. It is also considered efficacious as a feed flavouring compound under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

An essential oil from Origanum vulgare subsp. hirtum var. Vulkan (DOS 00001) is intended to be used as a sensory additive in feed for all animal species. In a previous opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the Panel concluded that the recommended use level of 150 mg additive/kg feed was safe for chickens for fattening and weaned piglets and this conclusion was extended to all poultry and porcine species grown for meat production. The Panel also concluded that the dose of 500 mg additive/head and day (equivalent to ~25 mg/kg complete feed) was safe for dairy cows. Since the recommended use level differs between the dairy cow and the non‐ruminants tested, the lower use level of 25 mg additive/kg feed was applied to all target animals not included above. The Panel also concluded that the additive was safe for the consumers and the environment, but should be considered as an irritant to skin and eyes and a potential skin and respiratory sensitiser in susceptible individuals. In the present application, the applicant has provided a new tolerance study in dairy cows to support the safety of a higher use level of 150 mg/kg for all animal species. Data on residues in milk from dairy cows fed the additive at the maximum recommended use level where also provided to assess consumer exposure. The Panel concluded that the essential oil under assessment is safe for cows at the recommended use level of 150 mg additive/kg feed. Since safety has been demonstrated in three major species with a comparable margin of safety, this conclusion on safety is extrapolated to 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 Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on an application for the authorisation of AviPlus®, an additive containing a mixture of sorbic acid, citric acid, thymol and vanillin, for use in turkeys for fattening and for breeding at a recommended dose range of 200–500 mg/kg complete feed and in suckling piglets at 1,000–3,000 mg/kg complete feed. AviPlus® is considered safe for turkeys for fattening and turkeys reared for breeding up to the maximum recommended dose of 500 mg/kg complete feed. For suckling piglets, the additive is safe up to the maximum recommended dose of 3,000 mg/kg complete feed. The additive is considered safe for the consumer and the environment. The additive is considered a potential skin/eye irritant and a skin sensitiser. The additive has the potential to be efficacious as a zootechnical additive in turkeys for fattening, turkeys reared for breeding at a minimum dose of 200 mg/kg complete feed. For suckling piglets, AviPlus® has the potential to be efficacious at a minimum dose of 1,000 mg/kg complete feed. [ABSTRACT FROM AUTHOR]

Bacillus subtilis DSM 28343 is a preparation of viable spores of a single strain of B. subtilis intended to be used as a zootechnical additive (functional group: gut flora stabilizer) in feed for calves for rearing to increase growth. In 2018, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Bacillus subtilis DSM 28343 as a feed additive for calves for rearing. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. In that opinion, the FEEDAP Panel was unable to conclude on the efficacy of the additive, under the condition of use as proposed by the applicant, due to insufficient data provided. In the current opinion, additional data to demonstrate the efficacy of Bacillus subtilis DSM 28343 were assessed. Based on one study of this application and two studies submitted in the previous application, the Panel concluded that Bacillus subtilis DSM 28343 has the potential to be efficacious as gut flora stabiliser used in feed for calves for rearing at the proposed use level. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of sodium selenate as a nutritional feed additive for ruminants, when used via an intraruminal bolus in ruminants. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel concludes that based on (i) the estimation of the release of selenium from the bolus, (ii) the similarities in bioavailability with sodium selenite, (iii) the experience with the use of boluses in ruminant nutrition and (iv) the wide margin of safety compared with the maximum tolerable levels of selenium in ruminants, the additive is safe for ruminants. The use of sodium selenate by bolus administration providing a selenium intake not exceeding that resulting from the maximum authorised EU level of total selenium in feed presents no concerns for consumer safety. The additive does not pose a risk to users by inhalation and is considered as non‐corrosive but irritant for the skin and the eyes. The FEEDAP Panel considers the additive as a skin sensitiser and respiratory sensitiser. The additive under assessment, in its intended use as complementary feed for ruminants in the form of boluses, is a substitute for other authorised selenium additives and will not further increase the environmental burden of selenium. Based on two studies submitted in cattle and sheep and studies from the literature, the FEEDAP Panel concludes that sodium selenate delivered by a bolus to ruminants is an efficacious source of selenium in meeting the animals' requirements. The Panel posed some recommendations regarding the use of the bolus, especially in small size ruminants. The Panel also posed a remark, concerning the zinc content of the bolus from which the additive is delivered. [ABSTRACT FROM AUTHOR]