Bacillus species are used in animal production directly as microbial feed additives or as the source of other feed additives, notably enzymes. The principal safety concern for consumers and, to a lesser extent livestock, associated with Bacillus is a capacity for toxin production. However, the capacity for toxin production and the nature of the toxins produced is unevenly distributed over the genus, occurring frequently in some species and more rarely in others. In principle, the selection of strains belonging to the B. cereus taxonomic group for direct use in animal production is considered inadvisable. If, however, they are proposed then the full genome should be sequenced and a bioinformatic analysis made to search for genes coding for enterotoxins and cereulide synthase. If there is evidence of homology, the non-functionality of the genes (e.g. mutation, deletion) must be demonstrated. For other species, concerns appear to be associated to the production of surfactin likelipopeptides, although the relation between the presence of these compounds and/or other toxic factors and the risk of illness in human has not yet been established. In the absence of animal models shown to be able to distinguish hazardous from non hazardous strains, the FEEDAP Panel relies on the use of in vitro cell-based methods to detect evidence of a cytotoxic effect. Such tests should be made with culture supernatants since the concentration of cells obtained in a broth culture would always exceed that found in animal food products. If the strain proves to be cytotoxic it is not recommended for use.

Chemical group 1 (CG 1) consists of straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols and acetals containing saturated aldehydes of which 86 are currently authorised for use as flavours in food. The FEEDAP Panel was unable to perform an assessment of ethyl oleate because of its insufficient purity. The following compounds are considered to be safe for all animal species at the use level proposed for feed flavourings: formic acid, acetic acid, propionic acid, octanoic acid, decanoic acid, dodecanoic acid, tetradecanoic acid, hexadecanoic acid, oleic acid, decanol, dodecanol, decyl acetate and dodecyl acetate. The remaining substances are considered safe for all animal species at 5 mg/kg complete feed (with a margin of safety between 1 and 120) and at 25 mg/kg complete feed (ethyl acetate and hexyl acetate, with a margin of safety between 2 and 6); and at 1 mg/kg complete feed for pigs and poultry and 1.5 mg/kg complete feed for all other species (ethylacrylate, ethyl hex-3-enoate, ethyl trans-2-butenoate, ethyl isobutyrate, ethyl isovalerate, butyl isovalerate, methyl isovalerate, hexyl isobutyrate, methyl 2-methyl butyrate, pentyl isovalerate, butyl 2-methyl butyrate, hexyl isovalerate, ethyl 2-methyl butyrate, hexyl 2-methyl butyrate and methyl 2-methylvalerate). No safety concern would arise for the consumer from the use of compounds belonging to CG 1 up to the highest safe level in feedingstuffs for all animal species. The FEEDAP Panel considers it prudent to treat all compounds under assessment as irritants to skin, eyes and respiratory tract and as skin sensitizers. No risk for the safety for the environment is foreseen. Since all 85 compounds are used in food as flavourings, no further demonstration of efficacy is necessary. SUMMARYFollowing 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 86 compounds (straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols and acetals containing saturated aldehydes belonging to chemical group 1) when used as flavourings for all animal species. All are currently authorised for use as flavours in food and all have been detected in plant materials, in fruits or in processed foods, however the reports of their distribution vary greatly.The FEEDAP Panel was unable to perform an assessment of ethyl oleate because of its insufficient purity.The following compounds are considered to be safe for all animal species at the use level proposed for feed flavourings:formic acid, acetic acid and propionic acid; octanoic acid, decanoic acid, dodecanoic acid, tetradecanoic acid, hexadecanoic acid and oleic acid;decanol, dodecanol, decyl acetate and dodecyl acetate.The following substances are considered safe:-for all animal species at 25 mg/kg complete feed with a margin of safety between 2 and 6: ethyl aceta...

The product L-threonine, technically pure, is an essential amino acid that contains by specification ≥ 98 % Lthreonine. It is produced by a genetically modified Escherichia coli strain. Neither the production strain nor its recombinant DNA was detectable in the final product. The final product does not raise safety concerns with regard to the genetic modification. L-Threonine, technically pure, is considered safe for the target animals when used to meet the requirements. The toxicological studies, including mutagenicity tests, performed with the additive or other sources of L-threonine did not reveal any toxic effect. Since the composition of tissues and products of animal origin will not be changed by the use of L-threonine in animal nutrition, and considering the high purity of the product under assessment, no risks are expected for the consumer from the use of L-threonine, technically pure, as a feed additive. The product is not irritating to the skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, there is no evidence of acute toxicity by the inhalation route. The use of the product as a feed additive does not represent a risk to the environment. LThreonine, technically pure, is considered as an efficacious source of L-threonine for all animal species. Response in ruminants requires some degree of protection of threonine from ruminal degradation. SUMMARYFollowing 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 the product L-threonine, technically pure, for all animal species.Threonine is an essential amino acid, considered as the second limiting amino acid in pig feed and probably as the third limiting in poultry feed. Supplementing feedingstuffs with free threonine would ensure that the animal requirements for that amino acid are met.The product L-threonine, technically pure, contains by specification ≥ 98 % L-threonine. It is produced by a genetically modified Escherichia coli strain.Neither the production strain nor its recombinant DNA was detectable in the final product. The final product does not raise safety concerns with regard to the genetic modification.L-Threonine, technically pure, is considered safe for the target animals when used to meet the requirements.The toxicological studies, including mutagenicity tests, performed with the additive or other sources of L-threonine did not reveal any toxic effect. Since the composition of tissues and products of animal origin will not be changed by the use of L-threonine in animal nutrition, and considering the high purity of the product under assessment, no risks are expected for the consumer from the use of Lthreonine, technically pure, as a feed additive.The product is not irritating to the skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, there is no evidence of acute tox...

Chemical group 16 consists of aliphatic and alicyclic ethers, of which four are currently authorised for use as flavours in food. The FEEDAP Panel was unable to perform an assessment of 1,5,5,9-tetramethyl-13-oxatricyclo[8.3.0.0.(4.9)]tridecane and theaspirane because of issues related to the purity of the compounds. The FEEDAP Panel concludes that: i)1,8-cineole is safe at the high use level proposed by the applicant (5 mg/kg complete feed) for all animal species with a margin of safety of 5.6 to 28.2; ii)2-(2-methylprop-1-enyl)-4-methyltetrahydropyran (Class II) is safe at a maximum of 0.3 mg/kg complete feed for cattle, salmonids and non food producing animals and of 0.5 mg/kg complete feed for pigs and poultry. The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of these substances. The total dose from all sources should not exceed that recommended when given in feed alone. No safety concern would arise for the consumer from the use of compounds belonging to CG 16 up to the highest safe level in feedingstuffs for all animal species. The FEEDAP Panel considers it prudent to treat both compounds under assessment as irritants to skin, eyes and respiratory tract, and as skin sensitisers. The FEEDAP Panel considers that the concentrations of the compounds belonging to CG 16 in the environment are not expected to exceed levels of concern when used in animal feeds at the levels considered to be safe to the target species. Since these compounds 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

FUMzyme® is an enzyme‐based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for growing pigs. It is produced from a genetically modified strain of Komagataella pastoris. The viable production strain and its recombinant genes are not present in the final product. Piglets showed no adverse effect when given feed containing 15‐times the maximum recommended dose. Consequently the FEEDAP Panel concludes that the additive is safe for pigs when used within the dose range proposed (15 – 300 units/kg feed). In studies with the additive, no evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity found in a subchronic oral toxicity study. Metabolites of fumonisin B1 produced by the action of the active agent have a lower toxicity than the parent compound. Consequently use of the additive in feed for pigs is considered safe for consumers of pork products. The additive is non‐irritant and is not a skin sensitiser but presents a hazard for respiratory sensitisation. The active substance of FUMzyme® is a protein and as such is largely degraded/inactivated during passage through the digestive tract of animals. In addition, any hydrolysis of fumonisins in the digestive tract would anticipate that which would occur naturally in soils. Therefore, no risks for the environment are expected. A number of short and long‐term feeding studies were made in which pigs were given feed contaminated with fumonisins with or without the additive. Each included a measure of the ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis. This ratio was significantly reduced in piglets by the addition of FUMzyme® at the minimum proposed dose when added to diets contaminated with fuminosins above and below the guidance limits operating in the EU. Sphinganine/sphingosine values generally returned to those seen in animals fed corresponding diets free from fumonisins.