Assessment of the feed additive consisting of folic acid for all animal species for the renewal of its authorisation (Chr. Olesen A/S and DSM Nutritional Products Ltd).

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

Safety and efficacy of a feed additive consisting of potassium ferrocyanide for all animal species (K + S KALI GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium ferrocyanide as a technological feed additive, functional group anticaking agents, for all animal species. The additive potassium ferrocyanide is intended to be used in potassium chloride with a maximum content of 150 mg ferrocyanide anion/kg salt. The use of potassium ferrocyanide is safe, when added to potassium chloride at a maximum content of 150 mg ferrocyanide anions (anhydrous)/kg for: pigs for fattening and lactating sows, sheep, goats, salmon and dogs. In the absence of a margin of safety, the use of potassium chloride according to the proposed conditions of use is not considered to be safe for chickens for fattening, laying hens, turkeys, piglets, veal calf, cattle for fattening, dairy cows, horse, rabbit and cats. In the absence of information on the use of potassium chloride in the diets for any other animal species, no conclusion on a potentially safe level of potassium chloride, supplemented with 150 mg ferrocyanide/kg, can be made. The use of potassium ferrocyanide in animal nutrition is of no concern for consumer safety. The results of in vivo studies showed that potassium ferrocyanide is not irritant to skin and eye and is not a skin sensitiser. However, due to the presence of nickel, the additive should be considered as a respiratory and dermal sensitiser. The available data do not allow the FEEDAP Panel to conclude on the safety of the additive for the soil and the marine environment, while the use of the additive in land-based aquaculture according to the proposed conditions of use is considered of no concern. Potassium ferrocyanide is considered to be efficacious as an anticaking agent when included in potassium chloride at the proposed use levels.

Safety and efficacy of feed additives consisting of sodium ferrocyanide and potassium ferrocyanide for all animal species (Eusalt a.i.s.b.l.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium and sodium ferrocyanide as technological feed additives for all animal species. The additives sodium- and potassium ferrocyanide are intended to be used in sodium chloride with a maximum content of 80 mg ferrocyanide anion (anhydrous)/kg salt. The FEEDAP Panel concluded that the use of sodium ferrocyanide and potassium ferrocyanide is safe, when added to sodium chloride at a maximum content of 80 mg ferrocyanide anion/kg for: turkey for fattening and laying hens and other laying/breeding birds; all porcine species and categories, all ruminant species and categories, rabbit, horse, salmonids and other minor fin fish, dogs and cats. In the absence of a margin of safety, the use of sodium and potassium chloride according to the proposed conditions of use is not considered to be safe for chickens for fattening and other poultry species for fattening or reared for laying/breeding other than turkeys. In the absence of information on the use of sodium chloride in the diets for any other animal species, no conclusion on a potentially safe level of sodium chloride, supplemented with 80 mg ferrocyanide anions (anhydrous)/kg, could be made. The use of sodium and potassium ferrocyanide in animal nutrition under the conditions of use proposed is of no concern for consumer safety. The results of in vivo studies showed that sodium and potassium ferrocyanide are not irritant to skin and eye and are not skin sensitisers. However, owing to the presence of nickel, sodium ferrocyanide, is considered a dermal and respiratory sensitiser. No conclusions could be reached on the safety of the user exposed via inhalation for potassium ferrocyanide. The use of sodium and potassium ferrocyanide as feed additives is considered safe for the environment. The additives are considered to be efficacious as anticaking agents in sodium chloride at the proposed use level.

Safety and efficacy of a feed additive consisting of chromium propionate (KemTRACE™ Chromium) for all growing poultry species (Kemin Europa NV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of chromium propionate (KemTRACE™ Chromium; KemTRACE-Cr) as zootechnical feed additive for all growing poultry species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. Based on two tolerance studies submitted, the Panel concluded that the additive is safe for chickens for fattening at the maximum recommended supplementation level of 0.4 mg Cr/kg feed from KemTRACE-Cr, but a margin of safety cannot be established; this conclusion can be extended to chickens reared for laying/breeding, but cannot be extrapolated to other growing poultry species. The FEEDAP Panel considered that the use of KemTRACE-Cr in animal nutrition at the proposed conditions of use is safe for the consumer. No concerns for users following any inhalation exposure during the handling of the additive are expected; the additive was shown to be corrosive to the eyes but not irritant to skin or a skin sensitiser. The use of KemTRACE-Cr in animal nutrition according to the proposed conditions of use will not significantly alter the concentration in the receiving environmental compartments of concern; therefore, no safety concern is expected for the environment. Based on three efficacy studies, the FEEDAP Panel concluded that KemTRACE-Cr has the potential to be efficacious as a zootechnical additive in chickens for fattening at the supplementation level of 0.4 mg Cr/kg feed; this conclusion could be extended to chickens reared for laying and chickens reared for breeding, and extrapolated to other poultry species for fattening and reared for laying/breeding.

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.

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.

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.

Safety of lactic acid and calcium lactate when used as technological additives for all animal species.

The additives under assessment are lactic acid and calcium lactate. In 2015, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of lactic acid and calcium lactate. The FEEDAP Panel could not conclude on the safety of lactic acid in pre-ruminants and poultry. 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. Based on the studies submitted in chickens for fattening and laying hens, no safe concentration of lactic acid and calcium lactate in complete feed for these species could be identified. Owing to the absence of data on tolerated dietary levels of d-lactic acid, no conclusion on the safety of lactic acid in milk replacer for pre-ruminants is possible. Since a safe concentration of lactic acid (and calcium lactate) was established only for pigs and cattle, and not for a third major animal species, no extrapolation to any other species is possible.

Safety and efficacy of natural mixture of illite, montmorillonite and kaolinite for all animal species.

The additive under assessment is a natural mixture mainly composed of illite (~ 53%), montmorillonite (~ 16%) and kaolinite (~ 17%). In 2016, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of a natural mixture of illite, montmorillonite and kaolinite (MIMK). The FEEDAP Panel concluded that the additive is safe for piglets and pigs for fattening at a maximum concentration of 20,000 mg/kg, and for cattle for fattening at a maximum concentration of 50,000 mg/kg. However, no conclusion could be drawn for all other species/categories. The Panel also concluded that the additive is efficacious at a minimum concentration of 50,000 mg/kg. 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 and on its efficacy at a minimum concentration of 20,000 mg/kg. The applicant submitted a new tolerance study in piglets and an analysis of the previous EFSA opinion regarding poultry and milk-producing animals. The FEEDAP Panel concluded that the additive is safe for piglets and pigs for fattening at 50,000 mg/kg. The Panel concluded that the safe level (50,000 mg/kg) found for cattle for fattening could be extrapolated to minor growing ruminants. The conclusion could be extrapolated to dairy cows and minor ruminant species for milk production. The FEEDAP Panel confirmed that no safe concentration of MIMK in feed for chickens for fattening could be identified. No conclusions could be drawn for all the other animal species/categories. The additive is effective as a pellet binder and an anticaking agent at the lowest level tested of 5,000 mg/kg feed.