Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Allura Red AC for small non-food-producing mammals and ornamental birds when used as an additive that add or restore colour in feedingstuffs. The use of Allura Red AC up to the proposed conditions of use of 500 mg/kg complete feed is considered safe for guinea pig, chinchilla, degu, hamster, gerbil and chipmunk. The following maximum safe levels (mg/kg complete feed) apply to the following species: ferrets 99, rabbits 123, canaries, budgerigars, mynah and toucans 45, lovebirds 51, cockatiels 79, cockatoos 115, amazons 145, parrots 147, yellow breast macaw 150, blue-throated macaw 173 and hyacinth macaw 214. The maximum safe level of Allura Red AC for other small non-food-producing mammal is 99 mg/kg feed and for other ornamental birds is 45 mg/kg feed. Inhalation exposure of Allura Red is regarded as hazardous. In the absence of data, the Panel cannot conclude on the potential of Allura Red to be a skin/eye irritant or a skin sensitiser. The FEEDAP Panel cannot conclude on the efficacy of the additive.

Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP-2789 (Miya-Gold® S) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and minor porcine species (Miyarisan Pharmaceutical Co. Ltd.).

The feed additive under assessment (trade name: Miya-Gold® S) is based on viable spores of Clostridium butyricum FERM BP-2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya-Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya-Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya-Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya-Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.

Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) as a feed additive for weaned piglets.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of the product Biosprint® (Saccharomyces cerevisiae MUCL 39885) as a feed additive for weaned piglets. Biosprint® is composed of only viable cells of Saccharomyces cerevisiae MUCL 39885. S. cerevisiae is considered by EFSA to have qualified presumption of safety status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of Biosprint® under the current authorised conditions of use is safe for weaned piglets, the consumers and the environment. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. There is no need to assess the efficacy of Biosprint® in the context of the renewal of the authorisation.

Safety of lignosulphonate for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of lignosulphonate, when used as a technological additive, functional group: binders. In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for target species and for the environment. The applicant provided additional information that was assessed in the current opinion. As regards the safety for the target species, the maximum recommended content of lignosulphonate of 10,000 mg/kg complete feed is considered safe in weaned piglet. A safe concentration of lignosulphonate in feed for salmonids and dairy cows could not be identified. The FEEDAP Panel reiterates also its previous conclusions that '10,000 mg lignosulphonate/kg complete feed is safe for chickens for fattening, laying hens and cattle for fattening but a margin of safety cannot be identified. Therefore, this conclusion cannot be extended to all animal species/categories'. Considering the absence of adverse effects confirmed by all the ecotoxicity studies up to very high concentrations, no concerns for the environment are expected from the use of this additive in animal nutrition according the conditions of use. Lignosulphonate is efficacious as pellet binder.

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 oct-1-en-3-ol, pent-1-en-3-ol, oct-1-en-3-one, oct-1-en-3-yl acetate, isopulegol and 5-methylhept-2-en-4-one, belonging to chemical group 5 and of isopulegone and α-damascone belonging to chemical group 8 when used as flavourings for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of oct-1-en-3-ol [02.023], pent-1-en-3-ol [02.099], oct-1-en-3-one [07.081], oct-1-en-3-yl acetate [09.281], isopulegol [02.067] and 5-methylhept-2-en-4-one [07.139], belonging to chemical group 5, and of isopulegone [07.067] and α-damascone [07.134] belonging to chemical group 8, when used as feed flavourings for all animal species. They are currently authorised for use as flavours in food. The FEEDAP Panel was unable to assess the safety of isopulegone because the purity of the compound could not be established and the safety of α-damascone [07.134] because of the inconclusive assessment of its genotoxicity. The FEEDAP Panel concluded that the use of isopulegol [02.067] is safe at the maximum proposed dose of 5 mg/kg complete feed for all animal species, except cats for which the use level of 1 mg/kg is considered safe. 5-Methylhept-2-en-4-one [07.139] is safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species. For oct-1-en-3-ol [02.023], pent-1-en-3-ol [02.099], oct-1-en-3-one [07.081] and oct-1-en-3-yl acetate [09.281], the calculated safe use level is 1 mg/kg complete feed for all animal species, except cats for which the calculated safe level is 0.6 mg/kg. No safety concern would arise for the consumer from the use of these compounds up to the highest safe levels in feed. In the absence of studies to assess the safety for the user, the FEEDAP Panel cannot conclude on the safety for the users when handling the additives. Use of the compounds in animal feed at the maximum safe level is considered safe for the environment. Since the compounds are used in food as flavourings and their function in feed is essentially the same, no demonstration of efficacy is necessary.

Safety and efficacy of l-cysteine hydrochloride monohydrate produced by fermentation using Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 as a flavouring additive 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 the safety and efficacy of l-cysteine monohydrochloride monohydrate produced by fermentation using two genetically modified strains of Escherichia coli K12 (Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181) as a flavouring additive for all animal species. No safety concerns are derived from the use of these strains as production strains of the additive. The FEEDAP Panel concludes that l-cysteine hydrochloride monohydrate, produced by E.coli KCCM 80180 and KCCM 80181 at concentrations up to 25 mg/kg complete feed, is safe for the target species, for the consumer and for the environment. The product is proposed to be classified as respiratory irritant; however, exposure by inhalation is unlikely. l-Cysteine hydrochloride monohydrate produced by E.coli KCCM 80180 and E.coli KCCM 80181 was shown to be a skin and eye irritant but not a skin sensitiser. Since l-cysteine hydrochloride monohydrate is used in food as flavouring, it is to be expected that it can provide a similar function in feed and no further demonstration of efficacy is necessary when used at concentrations up to 25 mg/kg complete feed and the corresponding concentration in water.

Assessment of the application for renewal of the authorisation of Amaferm® (fermentation product of Aspergillus oryzae NRRL 458) as a feed additive for dairy cows.

AMAFERM ® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for cows. This scientific opinion concerns the renewal of the authorisation of this additive for its use in dairy cows. In its former opinion, the EFSA Panel on Additives and Product or Substances used in Animal Feed (FEEDAP), based on the data and knowledge available at that time, concluded that the additive is safe for cows, for the consumers and the environment. In that assessment, the Panel also concluded that the additive is non-irritant or a dermal sensitiser but should be considered a potential respiratory sensitiser. The applicant provided new information regarding the characterisation of the additive in terms of enzyme activities as well as information concerning the production strain. Regarding the enzyme activities in the fermentation product, weaknesses and limitations in the methods of analysis were noted. The information regarding the production strain did not permit to confirm its taxonomic classification, moreover uncertainty remains regarding the presence of viable cells/spores in the final product. Therefore, the FEEDAP Panel could not confirm the previously drawn conclusions regarding the safety of the production strain and consequently could not confirm the safety for the target species and consumers. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety of hexamethylene tetramine for pigs, poultry, bovines, sheep, goats, rabbits and horses.

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 hexamethylene tetramine (HMTA) for pigs, poultry, bovines, sheep, goats, rabbits and horses. In 2015, the FEEDAP Panel delivered an opinion on the safety and efficacy of HMTA. In that opinion, the Panel noted that the residues of HMTA in the silage amounted to about 5% of the inclusion level of 600 mg HMTA/kg fresh ensiling material. Since the HMTA residues in silage were analysed as formaldehyde, it was not possible to quantify the contribution of formaldehyde and HMTA to the residues. In the absence of a qualitative and quantitative characterisation of the residues, the Panel could not conclude on the safety of HMTA for the target species. Based on the results of a new study in which HMTA was measured in silage, the concentration of HMTA dropped below the limit of quantification of 6 mg HMTA/kg silage, which corresponds to ~ 1% of the HMTA inclusion level in the fresh ensiling material. However, the formaldehyde concentration was not analysed in the silage. In the absence of a qualitative and quantitative characterisation of the residues, the Panel cannot conclude on the safety of HMTA for the target species.

Safety and efficacy of l-tryptophan produced by fermentation using Escherichia coli CGMCC 7.267 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-tryptophan produced by fermentation with a genetically modified strain of Escherichia coli CGMCC 7.267 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli CGMCC 7.267 is safe for the production of l-tryptophan. No viable cells or DNA of the production strain were detected in the additive under assessment. The use of l-tryptophan produced using E. coli CGMCC 7.267 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non-ruminant target species. However, excess doses would create amino acid imbalances with negative consequences on animal performance. The use of unprotected l-tryptophan in feed poses safety concerns for ruminants. The use of l-tryptophan produced by fermentation with E. coli CGMCC 7.267 in animal nutrition is considered safe for the consumers and for the environment. The endotoxin activity in the product and its dusting potential indicate an inhalation risk for the user. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and eyes or to be a skin sensitiser. The additive l-tryptophan produced using E. coli CGMCC 7.267 is regarded as an effective source of the amino acid l-tryptophan. In order to be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.

Assessment of the application for renewal of authorisation of Ecobiol® (Bacillus amyloliquefaciens CECT 5940) as a feed additive for chickens for fattening and its extension of use for chickens reared for laying.

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 Ecobiol® when used as a zootechnical additive in feed for chickens for fattening and chickens reared for laying at 1.0 × 109 colony forming units (CFU)/kg feed. Ecobiol® is the trade name for a feed additive based on Bacillus amyloliquefaciens CECT 5940, currently authorised for use in chickens for fattening. This opinion concerns the renewal of the authorisation of Ecobiol® for chickens for fattening and the evaluation of the new use with chickens reared for laying. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concludes that Ecobiol® is safe under the current conditions of authorisation for the target species (chickens for fattening and chickens reared for laying), consumers of products from animals fed the additive and the environment. Ecobiol® is not irritant to skin/eye or a skin sensitiser but should be considered a potential respiratory sensitiser. Due to a high dusting potential, exposure of users by inhalation is likely. There is no need for assessing the efficacy of Ecobiol® in the context of the renewal of the authorisation. The additive, at the level of 1 × 109 CFU/kg feed, has the potential to be efficacious in chickens reared for laying.

Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive 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 the safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory feed additive for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid. Considering the contradictory data from the Ames tests and uncertainty about the qualitative and quantitative presence of flavonoids and other compounds in the extract from M. officinalis L. leaves, the FEEDAP Panel could not conclude on the genotoxicity of the additive under assessment. Although the identified components of the extract do not raise concerns for the safety of target species, the analysis of the extract is incomplete. In the absence of adequate analytical and safety data, the FEEDAP Panel is unable to conclude on the safety of the additive for the target species. The use of M. officinalis L. leaf dried extract in animal feed at the proposed use level does not raise significantly the exposure levels of the consumer for compounds derived from this plant. However, in the absence of adequate data on genotoxicity, the Panel cannot conclude on the safety for the consumer. In the absence of specific studies, the FEEDAP Panel cannot conclude on the safety of the additive for the user. M. officinalis L. is a native species to Europe and its use in animal nutrition is not expected to pose a risk for the environment. Since M. officinalis L. and its extracts are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the extract.

Safety and efficacy of 4-phenylbut-3-en-2-one and benzophenone belonging to chemical group 21 when used as flavouring compounds for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 4-phenylbut-3-en-2-one [07.024] and benzophenone [07.032] belonging to chemical group 21, when used as feed flavourings for all animal species. They are currently authorised for use as flavours in food. The use of 4-phenyl-3-butene-2-one [07.024] is safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species. Benzophenone [07.032] is safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species except chicken for fattening, laying hens and piglets, for which the calculated safe concentration in feed is 0.5 mg/kg. No safety concern would arise for the consumer from the use of 4-phenyl-3-butene-2-one [07.024] and benzophenone [07.032] as feed flavourings. In the absence of studies to assess the safety for the user, the FEEDAP Panel cannot conclude on the safety for users when handling the additives. The use of 4-phenyl-3-butene-2-one [07.024] and benzophenone [07.032] in animal feed at the maximum safe use level in feed is also considered safe for the environment. Since the compounds under assessment are used in food as flavourings and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

Safety and efficacy of a dried aqueous ethanol extract of leaves from Olea europaea L. when used as a sensory additive in feed 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 the safety and efficacy of a dried aqueous ethanol extract of leaves from Olea europaea L., when used as a sensory feed additive for all animal species. The extract is specified to contain ≥ 20% oleuropein. As a full analysis of the extract was not provided, about 70% of the extract remained uncharacterised. In view of the inadequate chemical and toxicological characterisation of the additive, the FEEDAP Panel is unable to conclude on the safety for the target species, the consumers and the users. O. europaea L. is a native species to Europe where it is widely grown for commercial purposes. Use of the extract from the plant in animal production is not expected to pose a risk for the environment. In the absence of data showing the sensory properties of the additive under assessment, the Panel could not conclude on the efficacy of olive leaf extract from O. europaea L. when used as sensory additive.

Safety and efficacy of l-lysine monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 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 l-lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 when used as a nutritional additive in feed and water for drinking for all animal species. The active substance is l-lysine and it is produced in two different forms (monohydrochloride or sulfate salts). None of those forms pose any safety concern associated with the genetic modification of the production strain. l-Lysine HCl and l-lysine sulfate produced by C. glutamicum CGMCC 7.266 are considered safe for the target species, for the consumer and for the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via feed and water for drinking, simultaneously. In the absence of data, the FEEDAP Panel cannot conclude on the safety of both forms of the additive for the user. The products under assessment are considered efficacious sources of the amino acid l-lysine for all animal species. For these products to be as efficacious in ruminants as in non-ruminant species, they require protection against degradation in the rumen.

Safety and efficacy of l-cystine produced using Pantoea ananatis strain NITE BP-02525 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-cystine produced using Pantoea ananatis NITE BP-02525 when used as a nutritional additive (amino acid) or as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. l-Cystine is a dispensable sulfur-containing amino acid, naturally occurring in proteins of plants and animals. The amino acid l-cystine produced by fermentation with P. ananatis NITE BP-02525 is safe for all animal species, if the requirements for sulfur-containing amino acids are respected. The maximum amount of l-cystine that can be safely added to the diet will depend on the levels of other sulfur amino acids. This conclusion would also cover its use as a sensory additive. The use of l-cystine produced by fermentation with P. ananatis NITE BP-02525 in animal nutrition raises no safety concerns to consumers of animal products. The additive under assessment is considered slightly irritating by inhalation, not irritating to the skin or eyes and is not a skin sensitiser. There is no risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of the l-cystine produced by fermentation with P. ananatis NITE BP-02525 as a feed additive does not represent a risk to the environment. l-Cystine is considered efficacious in partially meeting the requirements of sulfur-containing amino acids in all animal species. For the supplemental l-cystine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen. It is also considered efficacious as a feed flavouring compound under the proposed conditions of use.

Safety and efficacy of l-isoleucine produced by fermentation with Corynebacterium glutamicum KCCM 80189 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 the safety and efficacy of l-isoleucine produced by fermentation using Corynebacterium glutamicum KCCM 80189 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is not genetically modified. Viable cells of the production strain were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. l-Isoleucine produced using C. glutamicum KCCM 80189 is considered safe for the target species, for the consumer and for the environment. l-Isoleucine produced by C. glutamicum KCCM 80189 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. l-Isoleucine produced by C. glutamicum KCCM 80189 is considered as an efficacious source of the essential amino acid l-isoleucine for non-ruminant animal species. For the supplemental l-isoleucine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

Assessment of the application for renewal of authorisation of l-isoleucine produced by Escherichia coli FERM ABP-10641 as a nutritional additive, its extension of use in water for drinking and a new use as flavouring additive 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-isoleucine produced by Escherichia coli FERM ABP-10641 (i) to renew the authorisation and to extend the use of the additive in water for drinking when used as a nutritional additive for all animal species and (ii) to evaluate a new use as a flavouring additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. l-Isoleucine does not give rise to any safety concern regarding the production strain and its genetic modification. Considering that the production process has not been substantially modified and that no adverse effects have been reported in the literature search, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in previous assessments. Therefore, the Panel considers that the additive l-isoleucine produced by E. coli FERM ABP-10641 remains safe for the target species, consumer and for the environment when used as a nutritional additive in feed. The Panel extends these conclusions to the use of the additive as a flavouring compound. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety for the target species of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. l-Isoleucine is not irritant to skin and eyes and is not a dermal sensitiser but is hazardous by inhalation. The Panel confirms the previous conclusions that the additive is considered as a source of available isoleucine for non-ruminant animal species when used as a nutritional additive. It requires protection against degradation in the rumen to be as efficacious in ruminants as in non-ruminant species. The Panel considers the use of the additive in water for drinking to be equally effective than the use in feed when used as a nutritional additive. Since l-isoleucine is used in food as a flavouring compound, and its function in feed is essentially the same as that in food no further demonstration of efficacy is necessary.

Safety and efficacy of saponified paprika extract, containing capsanthin as main carotenoid source, for poultry for fattening and laying (except turkeys).

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 saponified paprika extract, containing capsanthin as main carotenoid source, for poultry for fattening and laying (except turkeys). The saponified paprika (Capsicum annuum) extract contains various carotenoids at a concentration of 25-90 g/kg of which capsanthin being the major one with quantity specified as > 35% of total carotenoids (TC). The maximum recommended use level of 40 mg TC/kg feed is safe for chickens for fattening and laying hens. The margin of safety is at least 6. This conclusion is extrapolated to minor poultry species for fattening and laying. The saponified paprika extract is not genotoxic. Based on the no observed effect level (NOEL) of the 90-day study in rat and the exposure estimates, the Panel considered that there would be an adequate margin of exposure (between 700 and 2000) to conclude that the level of exposure to residues of the saponified paprika (C. annuum) extract (capsanthin not less than 35% of TCs) in animal tissues and products does not raise concern for the safety for the consumer. The saponified paprika extract is a viscous paste and as such users will not be exposed by inhalation. The applicant recognises that the extract may be irritant to skin and eyes. The FEEDAP Panel cannot conclude on the potential of any preparation to be toxic by inhalation, skin/eye irritant or skin sensitiser since no data were submitted. The use of saponified paprika extract in poultry feed raised no concern for the environment. Saponified paprika extract has the potential to pigment broiler skin and egg yolk. This conclusion is extrapolated to minor poultry species for fattening and laying.

Assessment of the application for renewal of authorisation of Formi™ LHS (potassium diformate) for sows.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Formi™ LHS (potassium diformate) for sows. The Panel considers that the information provided by the applicant does not fulfil the minimum requirements to support that Formi™ LHS remains safe under the approved conditions for target species, consumers and users. The Panel concludes that the use of Formi™ LHS under the approved conditions remains safe for the environment. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive.