Safety of 41 flavouring compounds providing a herbal flavour and belonging to different chemical groups for use as feed additives in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 41 compounds to provide a Herbal flavour and belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fourteen out of the 41 compounds were tested in tolerance studies in chickens for fattening, piglets, cattle for fattening and Atlantic salmon. No adverse effects were observed in the tolerance studies at 10-fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 14 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 27 compounds, read-across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 27 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer and the environment from the use of the 41 compounds up to the maximum proposed use level in feed.

Assessment of the safety of the feed additives acetic acid, calcium acetate and sodium diacetate for fish (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of acetic acid, calcium acetate and sodium diacetate as technological feed additives (preservatives) for salmonids/fish. The additives are already authorised for use for all animal species other than fish. In previous opinions, the FEEDAP Panel concluded that a maximum concentration of 2,500 mg acetic acid/kg complete feed (or 1,000 mg/L water for drinking) was safe for poultry, pigs and pet animals. Ruminants were considered to exhibit a higher tolerance. Due to lack of data for salmonids, the Panel could not conclude on the safety of acetic acid and its salts for fish. The applicant has provided supplementary information consisting in a tolerance study in Atlantic salmon (Salmo salar) and a literature search to support the safety of acetic acid in fish. Considering all the available information, the FEEDAP Panel concluded that acetic acid (and its salts by analogy) is considered safe for fish up to the maximum recommended supplementation level of 2,500 mg acetic acid/kg complete feed.

Assessment of the application for renewal of authorisation of l-histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-histidine monohydrochloride (HCl) monohydrate produced by fermentation using Escherichia coli NITE SD 00268 in the context of the renewal of the authorisation for salmonids when used as a nutritional additive. In addition, the applicant requested the extension of use of the additive for other fin fish. The applicant has provided evidence that the composition of the additive currently in the market complies with the conditions of authorisation. The production strain has been modified by conventional mutagenesis and it does not raise safety concerns. The use of l-histidine HCl monohydrate produced by fermentation using E. coli NITE SD 00268 is safe for salmonids and other fin fish when used as a nutritional additive to supplement the diet in appropriate amounts to cover the nutritional requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. The FEEDAP Panel considers the maximum total concentration of 1.7% histidine in feed for salmonids proposed by the applicant as safe. For other fin fish species, the level of 1.7% appears to cause adverse effects. Therefore, it is not possible to define a maximum concentration of histidine in fish other than salmonids as it depends on histidine nutritional requirements in the different fish species. The use of the authorised additive in salmonids production does not pose a risk for consumers, and the proposed maximum total concentration of 1.7% histidine in feed is considered safe for the consumer. l-Histidine HCl monohydrate produced using E. coli NITE SD 00268 supplemented at levels appropriate to cover the nutritional requirements of fish other than salmonids is considered safe for the consumer. The additive under assessment is not a skin irritant. In the absence of data, it is not possible to conclude on the potential of the additive to be toxic by inhalation, irritant to eyes or a skin sensitiser. The amino acid l-histidine is a natural component of plants and animals. The use of the additive under assessment in animal nutrition does not represent a risk to the environment. The additive is considered an efficacious source of the amino acid l-histidine for fish species.

Medium-chain glycerides affect gut morphology, immune- and goblet cells in post-weaning piglets: In vitro fatty acid screening with Escherichia coli and in vivo consolidation with LPS challenge.

The influence of medium-chain glycerides on performance and gastrointestinal well-being in weaning piglets was assessed. First, caproic (C6), caprylic (C8) and capric (C10) acid activity against Escherichia coli was screened in vitro. Pig flora of the whole small intestine was used as inoculum. Seven in vitro incubations were done in duplicate at pH = 3 and 5: C10 (15 mM), C8 (12 mM), C6 (15, 12, 10 mM), a non-incubated-negative control and incubated negative control. Culture suspensions were plated on E. coli-selective agar. Controls showed bacterial growth. C6 and C8 showed no growth at both pH-values, where C10 showed growth at pH = 5. Secondly, an in vivo study was done with 80 weaned piglets over 42 days, housed in pens of eight animals (five pens/treatment), fed a basal diet containing broken rice/soya bean meal/fish meal and supplemented with C6 and C8 in medium-chain glyceride form (MCT6/8, 0.175%) or antibiotic growth promoter (AGP, 0.020%) (Kasetsart University, Thailand) serving as control. Feed intake, daily gain and feed-to-gain ratio did not differ between MCT6/8 and AGP. Per replicate, two random selected piglets were challenged intravenously with E. coli-lipopolysaccharide (LPS) or saline solution (S) at Days 21 and 28. All challenged animals were sacrificed; blood and digestive tract samples (jejunum/ileum) were collected at Day 35. LPS challenge consistently reduced villus height and crypt depth for MCT6/8 and AGP. However, LPS-challenged piglets supplemented with MCT6/8 restored villus height, where AGP did not. MCT6/8 piglets had higher serum IgA, more jejunal IgA-positive plasma cells and goblet cells than AGP. At the ileal level, results were similar, though less pronounced. The present study offers new insight in the benefits of MCT6/8 over AGP in the post-weaning period. There is in vitro anti-microbial action of C6 and C8 on E. coli. In vivo, MCT6/8 also has protective effects in the small intestine that may result in growth promotion.

Safety and efficacy of l-lysine monohydrochloride and concentrated liquid l-lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B-50775 for all animal species based on a dossier submitted by ADM.

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 a genetically modified strain of Corynebacterium glutamicum (NRRL B-50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. glutamicum NRRL B-50775 nor its recombinant DNA was detected in the final product. Therefore, the product does not pose any safety concern associated with the genetic modification of the production strain. l-Lysine HCl and concentrated liquid l-lysine (base) produced by C. glutamicum NRRL B-50775 are considered safe for the target species, for the consumer and for the environment. l-Lysine HCl produced by C. glutamicum NRRL B-50775 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 NRRL B-50775. Concentrated liquid l-lysine (base) produced by C. glutamicum NRRL B-50775, due to its high pH (11) it 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 NRRL B-50775 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.

Safety and efficacy of l-lysine monohydrochloride and concentrated liquid l-lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL-B-67439 or NRRL B-67535 for all animal species.

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.

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding.

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

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction.

A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions is the subject of this assessment. The active substance is considered to be CLA (t10,c12) methyl ester (ME). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA previously issued an opinion on the safety and efficacy of the product, in which it could not conclude on the efficacy of this additive for sows for reproduction and for cows for reproduction. The European Commission asked EFSA to deliver an opinion on the efficacy of this additive for sows and cows for reproduction, based on additional data submitted by the applicant. The FEEDAP Panel has performed the assessment of the new data following an approach in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents. In relation to the data on efficacy in sows for reproduction, owing to methodological shortcomings of the study submitted, including the duration of the study and the limited biological relevance of the effect observed, the FEEDAP Panel cannot conclude on the efficacy of CLA (t10,c12)-ME for sows for reproduction. The data related to dairy cows indicate that dietary CLA (t10,c12)-ME supplementation in the late dry period and/or lactation period showed an increase of the probability of pregnancy and a reduction of time to conception in the same reproductive cycle. However, considering that the minimum duration of efficacy studies for reproductive parameters is of at least two reproductive cycles, the FEEDAP Panel is not in a position to conclude on the efficacy of the additive for cows for reproduction.

Safety and efficacy of l-lysine monohydrochloride and concentrated liquid l-lysine (base) produced by fermentation using Corynebacterium glutamicum strain KCCM 10227 for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-lysine monohydrochloride and concentrated liquid l-lysine (base) produced using Corynebacterium glutamicum KCCM 10227 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l-lysine. l-lysine HCl and concentrated liquid l-lysine (base) produced by the strain C. glutamicum KCCM 10227 do not represent a risk for the target species, the consumer and the environment. l-lysine HCl produced by C. glutamicum KCCM 10227 is hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. Concentrated liquid l-lysine (base) produced by C. glutamicum KCCM 10227 is hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l-lysine HCl and concentrated liquid l-lysine (base) 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.

Safety and efficacy of l-histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-histidine monohydrochloride (HCl) monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80172 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is genetically modified. The production strain and its recombinant DNA were not detected in the final product. l-Histidine HCl monohydrate manufactured by fermentation using C. glutamicum KCCM 80172 does not give rise to any safety concern regarding the genetic modification. The use of l-histidine HCl monohydrate produced by fermentation using C. glutamicum KCCM 80172 is safe for the target species when used as a nutritional additive to supplement the diet in appropriate amounts to cover the requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80172 supplemented at levels appropriate for the requirements of the target species is considered safe for the consumer. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80172 is not irritant to skin, is a mildly irritant to eyes, and it is not a skin sensitiser. The additive does not pose a risk to users by inhalation. The use of l-histidine HCl monohydrate produced by C. glutamicum KCCM 80172 in animal nutrition is not expected to represent a risk to the environment. l-Histidine HCl monohydrate is considered an efficacious source of the essential amino acid l-histidine for non-ruminant animal species. For the supplemental l-histidine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

Safety and efficacy of l-histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80179 for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-histidine monohydrochloride (HCl) monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80179 when used as a nutritional additive (amino acid) and as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is not genetically modified. No viable cells of the production strain were detected in the final product. The use of l-histidine monohydrochloride monohydrate produced by fermentation using C. glutamicum KCCM 80179 is safe for the target species when used as a nutritional additive to supplement the diet in appropriate amounts to cover the requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. This conclusion would also cover the use as a sensory additive. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 supplemented at levels appropriate for the requirements of species and life stage is considered safe for the consumer. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 is not irritant to skin, is mildly irritant to eyes, and it is not a skin sensitiser. The additive does not pose a risk to users by inhalation. The use of l-histidine HCl monohydrate produced by C. glutamicum KCCM 80179 in animal nutrition is not expected to represent a risk to the environment. l-Histidine HCl monohydrate is considered an efficacious source of the essential amino acid l-histidine for non-ruminant animal species. For the supplemental l-histidine 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.

Safety and efficacy of l-arginine produced by fermentation with Escherichia coli NITE BP-02186 for all animal species.

l-Arginine is considered as a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. l-Arginine produced by fermentation with Escherichia coli NITE BP-02186, genetically modified to enhance the production of l-arginine, is intended to be used in feed and water for drinking for all animal species and categories. The product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. Its use as a nutritional additive is safe for target species when supplemented to diets in appropriate amounts. The use of l-arginine as a feed flavouring agent is unlikely to pose any concern. No risks are expected for the consumer from the use of the product under assessment as a feed additive. It is not irritant to skin or eyes, nor a skin sensitiser. Although the presence of endotoxin activity is of no concern, the available exposure and toxicological data indicate that the additive may pose a risk to users by inhalation. The use of this additive in animal nutrition does not pose a risk to the environment. The additive is an effective source of arginine for all species. l-Arginine is considered efficacious when used as a flavouring compound in animal nutrition.

Safety and efficacy of l-arginine produced by fermentation using Corynebacterium glutamicum KCCM 10741P for all animal species.

l-Arginine is considered to be a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l-arginine produced by fermentation using a non-genetically modified strain of Corynebacterium glutamicum (KCCM 10741P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations at or below thresholds specified by EFSA; thus, C. glutamicum KCCM 10741P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded 99.8%, and no impurities of concern were detected. The use of l-arginine produced by C. glutamicum KCCM 10741P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. l-Arginine produced by C. glutamicum KCCM 10741P is considered corrosive to skin and eyes and therefore poses a risk by inhalation. The additive is an effective source of arginine for all species. For the supplemental l-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against microbial degradation in the rumen.

Safety and efficacy of betaine anhydrous for food-producing animal species based on a dossier submitted by AB Vista.

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 betaine anhydrous produced ■■■■■ as a nutritional additive to be used in feed for all food-producing animal species except rabbits. Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous tissues of vertebrates as an osmolyte ensuring osmoprotection. Betaine anhydrous (97%, 96% or 91%) is considered safe for the target species at a maximum supplementation rate of 2,000 mg betaine/kg complete feed. The use of betaine anhydrous (97%, 96% and 91%) as a feed additive up to a supplementation of 2,000 mg/kg complete feed does not pose concerns to consumer safety. The betaine liquid product contains a high proportion of unknown material (about 30% on dry matter basis). The FEEDAP Panel therefore cannot conclude on the safety of the liquid form of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety for the user. The supplementation of feed with betaine anhydrous does not pose a risk to the environment. Betaine has a potential to become efficacious in food-producing animal species and categories when administered via feed, especially when methyl groups from methionine or choline are limiting. The FEEDAP Panel made a recommendation on the use of the additive in premixtures without choline chloride.

Safety and efficacy of vitamin B12 (in the form of cyanocobalamin) produced by Ensifer spp. as a feed additive for all animal species based on a dossier submitted by VITAC EEIG.

Cyanocobalamin is a synthetic form of vitamin B12 used in pharmaceuticals, supplements and as a food additive. It is intended to be used in feed for all animal species and categories. 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 cyanocobalamin produced by fermentation with Ensifer adhaerens strains SCM 2034 or CICC 11008s or Ensifer fredii strain CMCC (B) 70000. Since relevant data were not provided by the applicant that would allow a proper identification and characterisation of the production strains, the Additives and Products or Substances used in Animal Feed (FEEDAP) Panel cannot conclude on the safety of the use of vitamin B12 produced using E. adhaerens CICC 11008s and E. fredii CMCC (B) 70000 in animal nutrition for the target animals, the consumer, the user and the environment. Due to significant uncertainties on the identity and safety of the production strain E. adhaerens SCM 2034, including the presence of antibiotic resistance genes, the absence of viable cells of the production strain or their DNA in the product, the FEEDAP Panel cannot conclude on the safety of the use of vitamin B12, produced by E. adhaerens SCM 2034 in animal nutrition for the target species, consumers and the environment. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, vitamin B12 produced by E. adhaerens SCM2034 is considered to pose a risk to user safety. Vitamin B12 additives produced by Ensifer spp. are regarded as effective in meeting animals' requirements.

Safety of l-lysine sulfate produced by fermentation with Escherichia coli CGMCC 3705 for all animal species.

In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of l-lysine sulfate produced by fermentation with Escherichia coli CGMCC 3705, when used as a nutritional additive for all animal species. The Panel concluded that a maximum supplementation of complete feed up to 1% l-lysine sulfate was considered safe for all animal species; its use in animal feed does not pose a risk to the consumer or the environment; l-Lysine sulfate was not considered a skin or eye irritant or a skin sensitiser, but should be considered a hazard by inhalation. The applicant originally proposed a specification of minimum 55% lysine. However, based on the data provided in the technical dossier, the FEEDAP Panel recommended that the additive should be specified to a l-lysine content ≥ 65%. The applicant seeks authorisation for l-lysine sulfate with a minimum content of 55% l-lysine. The Commission gave the applicant the possibility of submitting complementary information to complete its assessment. The additional data on the characterisation of the additive containing ≥ 55% l-lysine showed that > 99% of the product is comprised of known constituents, which do not give rise to safety concerns at the concentrations present. Therefore, the FEEDAP Panel considers that the conclusions of the previous opinion are applicable to the product l-lysine produced with E. coli CGMCC 3705 containing ≥ 55% l-lysine. Specifically, the FEEDAP Panel concludes that a maximum supplementation of complete feed up to 1% l-lysine sulfate is considered safe for all animal species; that the use in animal feed does not pose a risk to the consumer or the environment; and that l-Lysine sulfate is not considered a skin or eye irritant or a skin sensitiser, but should be considered a hazard by inhalation.

Safety of vitamin D3 addition to feedingstuffs for fish.

During 2012-2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued three opinions on the safety and efficacy of vitamin D3 for all animal species and concluded that no safety concern was identified for the use of vitamin D3 for fish at the maximum authorised content of 0.075 mg/kg feed. The Norwegian Food Safety Authority made available to the Commission some studies on the safety of vitamin D3 for fish and consumers at substantially higher levels (1.5 mg/kg feed) than those proposed by EFSA. The European Commission asked EFSA to review the information provided to estimate if it would be possible to increase the current levels of vitamin D3 in feed for fish. The increasing use of plant-based feed materials in aquaculture feeds could induce a decrease in vitamin D3 content in feedingstuffs. However, there is no evidence that the current total (background + supplemented) maximum EU content of vitamin D3 may cause any appreciable risk of deficiency in salmonids. The possible contribution of vitamin D2 in plant-based ingredients to the total vitamin D intake is considered to be low, although it cannot be reliably estimated. The FEEDAP Panel concludes that a total level of 1.5 mg vitamin D3/kg compound feed is safe for salmonids with a margin of safety of at least 10. For other fish, insufficient data are available to conclude on the safety of a total level of 1.5 mg vitamin D3/kg feed. Although the assessment of safety for the consumer is impaired by uncertainties concerning the transfer of vitamin D3 from feed to fish flesh, it was concluded that an increase of total vitamin D content in fish feeds up to 1.5 mg/kg feed would not lead the tolerable upper intake level to be exceeded even in high consumers.

Safety and efficacy of l-arginine produced by Corynebacterium glutamicum KCCM 80099 for all animal species.

l-Arginine is considered as a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l-arginine produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (KCCM 80099). It is intended to be used in feed and water for drinking for all animal species and categories. The following conclusions refer to the additive 'L-arginine produced by Corynebacterium glutamicum KCCM 80099'. Neither the genetically modified production strain nor its recombinant DNA were detected in the final product. The additive does not give rise to safety concerns with regard to the genetic modification of the production strain. The use of the additive is safe for target species when supplemented to diets in appropriate amounts, for the consumer and for the environment. The additive is not hazardous by inhalation, is not a skin sensitiser, but is corrosive to skin and eyes. The additive is an effective source of arginine for all species. For the supplemental l-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against microbial degradation in the rumen.

Effect of organic acids on Salmonella colonization and shedding in weaned piglets in a seeder model.

Piglets (n = 128) weaned at 21 days of age were used in a 35-day seeder model to evaluate the effects of dietary additives differing in active ingredients, chemical, and physical formulation, and dose on Salmonella colonization and shedding and intestinal microbial populations. Treatments were a negative control (basal diet), the positive control (challenged, basal diet), and six treatments similar to the positive control but supplemented with the following active ingredients (dose excluding essential oils or natural extracts): triglycerides with butyric acid (1.30 g kg(-1)); formic and citric acids and essential oils (2.44 g kg(-1)); coated formic, coated sorbic, and benzoic acids (2.70 g kg(-1)); salts of formic, sorbic, acetic, and propionic acids, their free acids, and natural extracts (2.92 g kg(-1)); triglycerides with caproic and caprylic acids and coated oregano oil (1.80 g kg(-1)); and caproic, caprylic, lauric, and lactic acids (1.91 g kg(-1)). On day 6, half the piglets (seeder pigs) in each group were orally challenged with a Salmonella Typhimurium nalidixic acid-resistant strain (4 × 10(9) and 1.2 × 10(9) log CFU per pig in replicate experiments 1 and 2, respectively). Two days later, they were transferred to pens with an equal number of contact pigs. Salmonella shedding was determined 2 days after challenge exposure and then on a weekly basis. On day 34 or 35, piglets were euthanized to sample tonsils, ileocecal lymph nodes, and ileal and cecal digesta contents. The two additives, both containing short-chain fatty acids and one of them also containing benzoic acid and the other one also containing essential oils, and supplemented at more than 2.70 g kg(-1), showed evidence of reducing Salmonella fecal shedding and numbers of coliforms and Salmonella in cecal digesta. However, colonization of tonsils and ileocecal lymph nodes by Salmonella was not affected. Supplementing butyric acid and medium-chain fatty acids at the applied dose failed to inhibit Salmonella contamination in the current experimental setup.