Scientific Opinion on the safety and efficacy of Urea for ruminants

Urea supplementation to feed for ruminants provides non-protein nitrogen for microbial protein synthesis in the rumen and thus in part replaces other dietary protein sources. Urea supplementation of feed for ruminants at doses up to 1 % of complete feed DM (corresponding to 0.3 g/kg bw/day) is considered safe when given to animals with a well adapted ruminal microbiota and fed diets rich in easily digestible carbohydrates. Based on the metabolic fate of urea in ruminants, the use of urea in ruminant nutrition does not raise any concern for consumers\u2019 safety. Urea is considered to be non irritant to skin and eyes and its topical use suggests that it is not a dermal sensitiser. The risk of exposure by inhalation would be low. The substitution of protein by urea in well balanced feed for ruminants would not result in an increased environmental nitrogen load. Urea is an effective source of non-protein nitrogen substituting for dietary protein in ruminants

Micronutrient and contaminant limits in aquafeeds

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Tissue metallothionein, apoptosis and cell proliferation responses in Atlantic salmon (Salmo salar L.) parr fed elevated dietary cadmium

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Metallothionein and cortisol receptor expression in gills of Atlantic salmon, Salmo salar, exposed to dietary cadmium

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Scientific Opinion on the safety and efficacy of Natuphos\uae (3-phytase) for minor avian species (quails, pheasants, partridges, guinea fowl, geese, pigeons, ostriches, peacocks, flamingos) and ornamental birds

The additive Natuphos is a preparation of 3-phytase produced by a genetically modified strain of Aspergillus niger. The product is currently authorised in the EU as a zootechnical feed additive for chickens and turkeys for fattening, laying hens, ducks, piglets, pigs for fattening and sows. The applicant is now asking for an extension of use to minor avian species and ornamental birds. The safety of phytase from Natuphos has been previously established in physiologically similar major poultry species with a margin of safety of more than ten times the respective maximum recommended doses. Therefore, considering the established mode of action of phytase and the wide margin of safety shown in the species evaluated, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that Natuphos is safe for minor avian species and ornamental birds at the maximum recommended dose (500 FTU/kg). Similarly, the efficacy of Natuphos in physiologically related major species has already been established. The mode of action of phytase can be reasonably assumed to produce the same effect in the major and minor avian species. Taking this into account and the experimental evidence provided in a balance study with geese, which showed an effect at 150 FTU/kg, the FEEDAP Panel concludes that the efficacy of Natuphos in minor avian species and ornamental birds can be assumed at the dose of 250 FTU/kg complete feed

Scientific opinion on the safety and efficacy of Calsporin\uae (Bacillus Subtilis) as feed additives for piglets

Calsporin is a microbial feed additive based on a single strain of Bacillus subtilis. The applicant is seeking authorisation for the use of the product with piglets at a proposed dose of 3*108 CFU/kg complete feedingstuff. The additive is currently authorised for use with chickens for fattening. The identity of the active agent was established in the previous application and belongs to a bacterial species whose safety EFSA considers can be assessed using the QPS approach. The strain is susceptible to antibiotics and evidence was previously provided to demonstrate a lack of toxigenic potential. Thus the product strain meets the qualifications attached to this group of bacilli, and the additive can be presumed safe for the target species, consumers and the wider environment. Five feeding trials are reported, each made with piglets given the additive at the proposed dose compared to matched groups fed the same diet without the additive. A significant improvement in feed to gain ratio and increase in final body weight and average daily gain in animals given the additive compared to control animals was seen in three trials. Consequently, Calsporin can be considered as effective at the proposed dose

Scientific Opinion on the safety of a copper chelate of hydroxy analogue of methionine (Mintrex\uae Cu) as feed additive for all species

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to consider additional data provided by the applicant subsequent to its former opinion on the efficacy and safety of MintrexCu for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the supplementary information supplied by the applicant on the safety for the target animals and consumers. Tolerance studies in piglets, laying hens and calves for rearing were submitted. Notwithstanding uncertainties due to the shortcomings of these studies, there were no indications suggesting that MintrexCu would present additional or different concerns for tolerance of piglets, laying hens or calves as compared to the authorised copper sulfate. Taking also into account the already assessed safety of MintrexCu for chickens for fattening, the FEEDAP Panel concluded that the use of MintrexCu would not pose a greater safety concern for target species studied than the authorised copper sulfate. Thus, the FEEDAP Panel concluded that MintrexCu is safe for all species up to the maximum copper (Cu) content authorised in feed. Tissue/products Cu deposition data were submitted for piglets (muscle, liver, kidney, skin/fat), laying hens (eggs) and dairy cows (milk). The FEEDAP Panel retains the Cu tissue deposition in the piglets study with MintrexCu for consumer exposure calculations. The use of this data is justified by (i) the high Cu content of piglet diet (170 mg/kg), and (ii) the higher supplementation of Cu in pigs over the entire production cycle compared to other animal species. Using this data as well as a model calculation based on SCOOP food consumption data, the FEEDAP Panel concluded that the use of MintrexCu in all animal species would lead to an additional consumer exposure not higher than 0.5 mg/day, compared to the use of copper sulfate. This difference is almost entirely attributable to liver Cu content. The estimated increase would not lead to the UL being exceeded by consumers. Therefore, the FEEDAP Panel concluded that the use of MintrexCu up to the maximum authorised Cu content in feed is safe for consumers