Suchergebnisse

Copper sulphate pentahydrate is safe for all animal species up to the maximum total copper content authorised in feed. No concerns for consumer safety are expected from the use of the feed additive. The maximum residue limits (MRLs) for copper in foods of animal origin established by European Union pesticides legislation are not consistent with legal practices in animal nutrition. As copper is an essential micronutrient, the FEEDAP Panel is not in favour of establishing MRLs for animal products, unless there is a clear consumer safety issue; if MRLs are to be maintained, the Panel has proposed amended values. The additive is an eye irritant and may induce allergic dermatitis in sensitive persons which might be exacerbated by the contamination with nickel. Users may be exposed to hazardous copper concentrations by inhalation. Potential risks to soil organisms have been identified after the application of piglet manure; there might be a potential concern related to sediment contamination. Drawing final conclusions would need further model validation and refinement to the assessment of copper-based additives in livestock. The use of copper compounds in aquaculture is not expected to pose a risk. The limited database available on the influence of copper to the development of antibiotic resistance in gut and soil bacteria indicates that high copper concentrations in the microbial environment increase the number of copper-resistant bacteria, and copper resistance seems to be correlated with more frequent resistance to several antibiotics in certain bacterial species. A potential copper threshold concentration could not be derived. The total pool of macrolide resistance in animals probably originates from antibiotic treatment and not from the use of high dietary copper. The extent to which copper-resistant bacteria contribute to the overall antibiotic resistance can not be quantified at present. Copper sulphate pentahydrate is efficacious in meeting animal requirements.

Zinc oxide is a safe source of zinc for all animal species and no concerns for consumer safety are expected from the use of zinc oxide in animal nutrition, considering the maximum contents for total zinc in feedingstuffs set by EU legislation. Zinc oxide is not an irritant to skin and eyes; it is not a skin sensitiser. The zinc oxide under application is considered a compound with high dusting potential, which may result in a critical exposure of users by inhalation, affecting the respiratory system. The authorised use of zinc oxide as a feed additive does not pose a direct concern for the agricultural soil compartment. However, there is a potential environmental concern related to groundwater, drainage and the run-off of zinc to surface water. Acid sandy soils are most vulnerable to these processes. In order to draw a final conclusion, some further refinement to the assessment of zinc-based feed additives in livestock needs to be considered, for which additional data would be required. The use of zinc-containing additives in aquaculture up to maximum authorised zinc level in feeds is not expected to pose an appreciable risk to the environment. Zinc oxide is efficacious in meeting animal zinc requirements.

Following a request from European Commission, the Panel on Additives and Product or Substances used in Animal Feed (FEEDAP) was asked to deliver an opinion on the safety and efficacy of Biomin C3 when used in diets for chickens for fattening. The additive Biomin C3 is a preparation of strains of Enterococcus faecium, Bifidobacterium animalis subsp. animalis and Lactobacillus salivarius subsp. salivarius. The product is intended to improve the performance of chickens for fattening when added in their diets at a minimum content of 1 x 108 and a maximum content of 1 x 109 CFU/kg of complete feedingstuffs. It has not been previously authorised in the European Union. The identity of the strains B. animalis subsp. animalis, L. salivarius subsp. salivarius and E. faecium has been established and no antibiotic resistance detected. On the basis of a tolerance study in which chickens for fattening showed no effects in the presence of 100 times the maximum recommended dose, the additive is considered safe for the target species at doses up to 1 109 CFU/kg of complete feedingstuffs Two of the three strains, B. animalis subsp. animalis and L. salivarius subsp. salivarius, satisfy the requirements for the qualified presumption of safety approach to safety assessment, and thus are presumed safe for consumers. The third strain, E. faecium, was shown not to contain marker genes typical of hospital-associated isolates responsible for clinical infections and does not raise additional safety concerns. Consequently, the FEEDAP Panel considers the use of the Biomin C3 safe for consumers. The additive is not irritant to skin or eyes and is not a skin sensitiser. Biomin C3 should be treated as a potential respiratory sensitiser as a result of its proteinaceous nature. The three species are natural components of gut microbiota and their use as Biomin C3 in animal feeding would not be expected to pose any additional risk to the environment. In four of the five studies carried out in chickens for fattening, Biomin C3 showed the potential to improve the performance of birds at the minimum dose of 1 x 108 CFU/kg of complete feedingstuffs. This was supported by a meta-analysis which showed significant improvements in final weight across the five trials. The three strains are compatible with robenidine hydrochloride, maduramycin ammonium and diclazuril but not with monensin sodium and lasalocid A sodium.