143 research outputs found
Safety and efficacy of l-lysine monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species
No full textFollowing 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 CCTCC M 2015595 when used as 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). Owing to the uncertainties regarding the possible genetic modification of the strain used to obtain the production strain C. glutamicum CCTCC M 2015595 and on the possible presence of viable cells and DNA of the production strain in the final product, the FEEDAP Panel cannot conclude on the safety of the additives l-lysine HCl and l-lysine sulfate produced with C. glutamicum CCTCC M 2015595 for the target species, the consumers, the users and the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via water for drinking. In the absence of data, the FEEDAP Panel cannot conclude on the safety 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 3-phytase FLF1000 as a feed additive for pigs for fattening and minor porcine species for growing
No full textFollowing 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 3-phytase FLF1000 as a feed additive for pigs for fattening and minor porcine species for growing. This additive contains 3-phytase produced by a genetically modified strain of Komagataella phaffii and it is authorised in the European Union as a feed additive for feed for chickens for fattening, laying hens, chickens reared for laying and for minor poultry species for fattening or reared for laying or for breeding. The applicant requested the extension of use of the additive to pigs for fattening and minor porcine species for growing. The FEEDAP Panel concluded that the use of the product as a feed additive for pigs raises no concerns for the consumer safety nor for the environment. The additive should be regarded as a potential respiratory sensitiser. The applicant provided a combined tolerance and efficacy trial in weaned piglets to support the safety for the target species. However, owing to the lack of precise data on the total feed intake of the animals, the FEEDAP Panel did not consider further the study for the assessment and consequently no conclusion could be drawn regarding the safety of the additive for pigs for fattening nor for other minor growing porcine species. Three studies were considered for the efficacy and from the data obtained the FEEDAP Panel concluded that the additive has the potential to be efficacious in improving the phosphorus utilisation in pigs for fattening at a minimum level of 500 FTU/kg feed
Safety and efficacy of Levucell® SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for all pigs
No full textFollowing 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 Levucell® SB when used in feed for suckling piglets, pigs for fattening and minor porcine species. Levucell® SB is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae currently authorised as a zootechnical additive for weaned piglets, sows, chickens for fattening and minor poultry species for fattening. The applicant is now seeking authorisation as a zootechnical additive for use with all pigs. In the context of a previous opinion, the identity of the strain was confirmed, and according to the Qualified Presumption of Safety (QPS) approach to safety assessment, it was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell® SB is also considered safe for the target species, including all pigs, consumers and the environment. Levucell® is not a skin or eye irritant or a skin sensitiser. Inhalation exposure is unlikely. Encapsulation used in the existing coated forms is not expected to introduce hazards for users. In previous opinions, Levucell® SB was found to have the potential to be efficacious in sows and weaned piglets at the dose of 1 9 109 colony forming units (CFU)/kg complete feedingstuffs. Since the dose proposed for use with all pigs is the same as that demonstrated to be effective in weaned piglets and sows, and it can be reasonably assumed that the mode of action is the same, the conclusion on efficacy for weaned piglets and sows can be extrapolated to all pigs. Therefore, the FEEDAP Panel concludes that Levucell® SB has the potential to be efficacious in all pigs at 1 9 109 CFU/kg feedingstuffs
Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species
No full textFollowing 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
Assessment of the application for renewal of authorisation of Levucell SC (Saccharomyces cerevisiae CNCM I-1077) as a feed additive for lambs and horses
No full textLevucell ® SC is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae. The product is currently authorised for use in feed for horses, lambs, dairy sheep and dairy goats, dairy cows and cattle for fattening. This opinion concerns the renewal of the authorisation of Levucell ® SC as a zootechnical additive for lambs and horses. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety for the target species, consumers and the environment. The identity of the strain present in the additive was established. Accordingly, this strain is presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell ® SC is also considered safe for the target species, consumers of products from animals fed the additive and the environment. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. Furthermore, according to the information provided in the technical dossier, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions on the safety of the product for target species, consumers, users and the environment under the authorised conditions of use. Levucell ® SC is an eye irritant
Safety and efficacy of TechnoSpore® (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds
No full textFollowing 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 TechnoSpore® (Bacillus coagulans DSM 32016), when used as a zootechnical additive for piglets (suckling and weaned), other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds. The bacterial species present in the additive is considered suitable for the qualified presumption of safety approach to safety assessment. The identity of the active agent was established and the lack of toxigenic potential confirmed. B. coagulans DSM 32016 did not show resistance to antibiotics of human and veterinary importance, and therefore, was presumed safe for the target species, consumers of products derived from animals Fed the additive and the environment. Since the other components of the additive did not give rise to concerns, TechnoSpore® was also considered safe for the target species, consumer and the environment. The additive is not a skin/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. TechnoSpore® showed the potential to be efficacious as a zootechnical additive in weaned piglets and chickens for fattening at 1 × 109 CFU/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae at the same physiological stage and to other birds for fattening and ornamental birds at the same use level. B. coagulans DSM 32016 included in Technospore® is compatible with halofuginone and diclazuril. The Panel could not conclude on the compatibility of the additive with monensin sodium, decoquinate, robenidine hydrochloride, lasalocid sodium, narasin, salinomycin sodium, maduramicin ammonium, nicarbazin and narasin/nicarbazin
Safety and efficacy of Actisaf ® Sc47 (Saccharomyces cerevisiae CNCM I-4407) as a feed additive for cattle for fattening, dairy cows, weaned piglets and sows
No full textFollowing 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 Actisaf ® Sc47 for dairy cows, cattle for fattening, weaned piglets and sows when used as a zootechnical additive. Actisaf ® Sc47 consists of viable cells of a strain Saccharomyces cerevisiae and is marketed in three formulations. The FEEDAP Panel considers that the three available formulations are equivalent when used to deliver the same dose of the microorganism in feed. The active agent fulfils the requirements of the qualified presumption of safety approach to the assessment of safety. Since the additive is composed of the active agent only, Actisaf ® Sc47 is also presumed safe for the target animals, consumers of products derived from treated animals and the environment. Actisaf ® Sc47 is not a skin irritant. In the absence of data, no conclusions can be drawn on the eye irritancy and dermal sensitisation potential of the additive. Inhalation exposure is unlikely. The additive has the potential to be efficacious in weaned piglets and sows to have benefits in piglets at the recommended dose of 5 × 10 9 CFU/kg feed. Insufficient evidence was provided to conclude on the efficacy of the additive in dairy cows and cattle for fattening
Modification of the terms of the authorisation of Natuphos® E as a feed additive for chickens for fattening or reared for laying/breeding
No full textThe additive Natuphos® E presents 6-phytase produced by a genetically modified strain of Aspergillus niger. The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets. The authorisation for chickens for fattening or reared for laying is at a minimum content of 750 FTU/kg feed. The applicant has requested to lower this dose to 125 FTU/kg feed. The Panel considered a total of three short-term trials and five long-term trials. In two short-term trials, the birds that received 125 FTU/kg feed showed a significantly better retention of phosphorus from the diets. Similarly, in two long-term trials, the birds that received 125 FTU/kg feed showed a significantly better performance. Consequently, the Panel concluded that the additive has a potential to improve the performance/phosphorus retention of the birds at the dose of 125 FTU/kg feed
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