Safety and efficacy of Manganese chelates of lysine and glutamic acid as feed additive for all animal species.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelates of lysine and glutamic acid (Manganese-LG) as nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. The Panel concluded that, owing to safety considerations, the simultaneous use of both feed and water supplemented with Manganese-LG should be avoided. Manganese-LG showed to be safe for chickens for fattening up to the maximum authorised levels in the EU for manganese in feed (150 mg/kg); however, since a margin of safety could not be derived, the conclusions could not be extrapolated/extended to other categories/species. The data showed that Manganese-LG does not increase nor change the patterns of manganese tissue deposition when administered up to the maximum level allowed in the EU; therefore, the Panel concluded that the additive is safe for consumers of tissues and products from animals fed the additive up to the total manganese content in feed authorised in the EU. Owing to the manganese and nickel content of Manganese-LG, the Panel concluded that the handling of the additive poses a risk to users by inhalation and shall be considered as a skin and respiratory sensitiser; the data showed that the additive is irritant to eye and non-irritant to skin. Manganese-LG, intended to substitute other authorised manganese additives, will not further increase the environmental burden of manganese; the Panel considered that the use of the additive in animal nutrition would not pose an additional risk for the environment. The Panel concluded that the additive is efficacious in chickens for fattening; this conclusion can be extrapolated/extended to other categories/species. The FEEDAP Panel posed a recommendation concerning the description of the additive.

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.

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species.

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 NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was initially authorised in 2007 with a content of 2,000-2,400 mg Se/kg (97-99 % of organic selenium) and in 2017 the authorisation was further amended to introduce a selenium range of 2,000-3,500 mg Se/kg. Additionally, in 2013, the initial authorising Regulation was modified to introduce a maximum supplementation selenium from this additive in feed (0.2 mg Se from Alkosel®/kg feed). 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 Alkosel® in animal nutrition does not pose a risk to consumers provided that the maximum selenium supplementation of 0.2 mg/kg feed from Alkosel® is not exceeded, yet respecting the maximum total selenium in feed of 0.5 mg/kg. Data on the characterisation of the additive and studies on skin/eyes effects led the Panel reconsider the safety for the user, concluding that Alkosel® is (i) hazardous upon inhalation, (ii) non-irritant to skin and considered irritant for the eyes and mucosae, and (iii) a dermal sensitiser and likely a respiratory sensitiser. A recommendation regarding the denomination of the additive under assessment was proposed by the Panel.

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 a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

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 safety and efficacy of sodium molybdate dihydrate for sheep, based on a dossier submitted for the re-evaluation of the additive. The additive is currently authorised in the EU for all animal species as 'Nutritional additive' - 'Compounds of trace elements'. Taking the optimal Cu:Mo ratio of 3-10, and the highest total copper level authorised in complete feeds for sheep (15 mg/kg), the FEEDAP Panel concluded that 2.5 mg total Mo/kg complete feed is safe for sheep. Considering (i) a safe intake of 0.6 mg Mo/day, (ii) the estimate average intake figure from food in Europe (generally less than 100 µg/day), (iii) the contribution of foods of animal origin to the total molybdenum intake (estimated to be up to 22 %), and (iv) that molybdenum would not accumulate in edible tissues/products of sheep fed molybdenum supplemented diets up to the upper safe level, the FEEDAP Panel concluded that the use of sodium molybdate as a additive in sheep at 2.5 mg total Mo/kg complete feed is safe for consumers. The additive under assessment feed poses no risk by inhalation to users; it is a skin and eye irritant, but it is not considered as a skin sensitiser. Sodium molybdate used up to 2.5 mg Mo/kg complete sheep feed poses no concerns for the safety for the environment. The FEEDAP Panel recognises that molybdenum does not need to be added to diets to cover the nutritional needs of molybdenum of sheep. Molybdenum supplementation in sheep feed is considered effective in order to guarantee an adequate balance with copper, when the Cu:Mo ratio in the diet is in the range 3-10.

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 zinc chelates of lysine and glutamic acid as feed additive for all animal species.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zinc chelates of lysine and glutamic acid (Zinc-LG) as a nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel concludes that, owing to safety considerations, the simultaneous use of both feed and water supplemented with Zinc-LG should be avoided. Zinc-LG is safe for chickens for fattening; this conclusion can be extrapolated to all animal species/categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded. No increases in the zinc content of animal tissues and products are expected from the use of Zinc-LG in animal nutrition. There is no indication that the toxicity of Zinc-LG is essentially different from that described for inorganic divalent zinc. The use of Zinc-LG in animal nutrition is of no concern for consumer safety provided that the maximum authorised total zinc levels in feed are respected. Owing to its zinc content, the handling of the additive poses a risk to users by inhalation. The additive is considered as a skin and respiratory sensitiser; it is non-irritant to eye and to skin. Zinc-LG is intended to be a substitute for other authorised zinc additives and will not further increase the environmental burden of zinc; therefore, the FEEDAP Panel considers that the use of the additive in animal nutrition would not pose an additional risk for the environment. Zinc-LG is a source of bioavailable zinc, comparable to the standard inorganic zinc source, and therefore, the additive is efficacious in meeting the birds zinc requirements; this conclusion can be extrapolated to all animal species/categories. The FEEDAP Panel posed a recommendation concerning the description of the additive.

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 sodium selenate as feed additive for ruminants.

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.

Safety and efficacy of Zinc-l-Selenomethionine as feed additive for all animal species.

The additive, 'Zinc-l-selenomethionine' (Zn-l-SeMet) is intended to be used as a source of selenium for all animal species. The applicant intends to market the active compound blended with inert carriers (Availa®Se). Zn-l-SeMet is a safe source of selenium for chickens for fattening; the conclusion is extended to all animal species. Selenium from Zn-l-SeMet does not elicit any adverse effects not expected for a selenium compound. The use of Zn-l-SeMet in animal nutrition is expected to result in a similar increase in selenium deposition in animal tissues/products as that resulting from other sources of SeMet. The use of the additive up to the maximum selenium supplementation level established for other sources of organic selenium (0.2 mg/kg complete feed) and complying with the maximum authorised total selenium content is safe for consumers. The additive is hazardous upon inhalation; owing to the high dusting potential, persons handling Availa®Se are at risk by inhalation. Availa®Se is not an irritant to the skin. In the absence of data, no conclusion on the eye irritation and skin sensitisation can be drawn. The use of Zn-l-SeMet in feed does not pose an additional risk to the environment, compared with other sources of selenium for which it will substitute, as long as the maximum authorised content in complete feed is not exceeded. Zn-l-SeMet is an effective source of selenium in chickens for fattening and laying hens; this conclusion is extended to all animal species. The maximum contribution of zinc in total feed deriving from the use of the additive (< 0.2 mg Zn/kg feed) is considered low and does not need any safety assessment except for users.

Safety of natural mixture of dolomite plus magnesite and magnesium-phyllosilicates (Fluidol) for all animal species.

The additive under assessment consists of a natural mixture, mainly composed of dolomite (~ 30%), magnesite (~ 20%) and magnesium-phyllosilicates (talc (~ 35%) and chlorite (~ 15%)). In 2016, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of natural mixture of dolomite plus magnesite and magnesium-phyllosilicates. In this opinion, the Panel concluded that 20,000 mg additive/kg complete feed is considered safe for dairy cows and for piglets (weaned). This conclusion was extended to pigs for fattening while no conclusion could be drawn on the safety for poultry or any other species/categories. Following this opinion, 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 new tolerance studies submitted with cattle for fattening and chickens for fattening showed tolerance of these animal categories to the additive up to approximately fivefold the highest recommended use level. The FEEDAP Panel therefore concluded that 20,000 mg additive/kg complete feed is safe for cattle for fattening and chickens for fattening. The additive at the same dietary concentration was already considered safe in an earlier opinion for piglets and dairy cows. Since the additive at 20,000 mg/kg complete feed is considered safe for four animal categories (three major animal species) with a comparable margin of safety, the conclusion on safety is extrapolated to all animal species. At the safe dietary concentration the additive did not affect the digestibility of the feed (including feed additives).

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.

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3060 (selenised yeast inactivated) for all animal species.

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.

Safety of natural mixture of dolomite plus magnesite and magnesium-phyllosilicates (Fluidol) for all animal species.

The additive under assessment consists of a natural mixture, mainly composed of dolomite (~ 30%), magnesite (~ 20%) and magnesium-phyllosilicates (talc (~ 35%) and chlorite (~ 15%)). In 2016, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of natural mixture of dolomite plus magnesite and magnesium-phyllosilicates. The FEEDAP Panel concluded that the additive is safe in complete feed for dairy cows, piglets and pigs for fattening at a maximum concentration of 20,000 mg/kg. However, no conclusions could be drawn for all other animal species/categories. Following this opinion, 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 answered with a new submission, an analysis of the previous EFSA opinion, but without new data. The FEEDAP Panel considered the arguments made by the applicant, in relation to the tolerance studies with dairy cows and chickens for fattening. No reason was identified to modify the conclusions reached in the previous opinion.

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.