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

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

Scientific opinion on the use of cobalt as additives in animal nutrition

In the light of genotoxicity of cobalt(II) compounds and their presumed carcinogenicity after inhalatory exposure, the use of cobalt compounds as additives in animal nutrition has been assessed, considering (i) the necessity of its use for all animal species, (ii) its implications for consumer safety and (iii) on the safety of persons handling cobalt compounds. Since the only known role of cobalt in animals is that of the central atom of vitamin B12, only animals with the capacity of synthesizing vitamin B12 in the intestinal tract like ruminants, horses and coprophagous rabbits can utilise cobalt. Consequently, there is no necessity for cobalt supplementation of feed for other animals. No data are available in the open literature on the potential carcinogenicity of cobalt following the exposure via the oral route either in humans or in experimental animals. The exposure of consumers to total dietary cobalt has been considered. There was no indication that the thresholds for non-carcinogenic events (i.e. cardio-myopathy, polycythaemia, goiter, evelopmental) would be exceeded at present. Users are exposed to cobalt compounds. In the re-evaluation of cobalt compounds their dusting potential deserves therefore particular attention. As a first step, the FEEDAP Panel recommends minimizing exposure of users. The FEEDAP Panel recommends modifying the authorisation of cobalt compounds in feedstuffs by (i) restricting the use of cobalt compounds as additives to feed for ruminants (except milk replacer), horses and rabbits, (ii) limiting cobalt supplementation in feed for ruminants (except milk replacer), horses and rabbits to a maximum of 0.3 mg Co/kg complete feed, and (iii) reducing the authorised maximum cobalt content from all sources from 2 to 1 mg/kg complete feed for all species except fish. Any negative consequences of these measures on animal health and the efficiency of animal production are not expected

Scientific Opinion on the safety and efficacy of Bonvital (Enterococcus faecium) as a feed additive for dogs

The microbial feed additive Bonvital is a preparation of Enterococcus faecium. The applicant is seeking authorisation of Bonvital as a feed additive for dogs at the dose of 1*109 CFU/kg of complete feedingstuff. The safety for the user and the environment has been considered in the context of previous opinions. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has considered only the safety and the efficacy of Bonvital for dogs. A tolerance test was performed on adult dogs fed a diet to which Bonvital was added at 50 times the proposed dose. Although no adverse effects were observed on their immunological and haematological parameters, the inadequate experimental design did not allow the FEEDAP Panel to draw conclusions on the safety of Bonvital for dogs. Six experiments were provided examining the effects of the additive at use level in dogs. Two studies gave data on faecal consistency and four on immunological parameters. Microbiological parameters were also measured in one of these studies. The observation of reduced Clostridium perfringens counts and the results on faecal consistency do not support the functional group gut flora stabiliser. Data on immune response were inconsistent due in part to an inadequate experimental design and a lack of consistency in observations. Lymphocyte proliferation in response to a mitogen challenge was significantly greater in treated dogs in two studies, but it was not demonstrated that these animals will show an increased response to a specific antigen. Although there appeared to be a greater IgG response in vaccinated animals given Bonvital, this was seen only as an increase in total IgG in one study and as a specific IgG titer in one other study. Consequently the FEEDAP Panel was unable to identify any consistent immune response which might be considered beneficial to the animal

Scientific opinion on the safety and efficacy of Formi\u2122 LHS (potassium diformate) as a feed additive for sows

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy of FormiTM LHS when used as a zootechnical additive in sows. This product has been authorised for use in piglets, pigs for fattening and sows. The applicant is now seeking re-evaluation of this additive for use in sows. FormiTM LHS is a feed additive consisting of potassium diformate intended to be used in sows at a proposed dose range of 8000-12000 mg/kg of complete feedingstuffs. A tolerance study made with sows and including FormiTM LHS at doses up to 5% showed no adverse effects. Consequently, the FEEDAP Panel concludes that FormiTM LHS is safe for use in sows at a maximum dose of 1.2%, with a margin of safety of approximately four. Although FormiTM LHS has a potential antimicrobial effect in the gastrointestinal tract, the nature of the product makes selection for bacteria resistant to clinically relevant antibiotics unlikely. There was no evidence of genotoxicity of FormiTM LHS. The acute oral toxicity was low, and no adverse subchronic effects at the tested dose levels were detected in laboratory animal studies. In chronic studies, the NOAEL was 50 mg/kg body weight/day for forestomach irritation in rats. In addition, data from residues studies in pigs indicate that no increase in the intake of formate is expected from consumption of animal tissues when FormiTM LHS is used. The FEEDAP Panel concludes that the use of FormiTM LHS as a feed additive in sows under the proposed conditions of use is safe for the consumer. FormiTM LHS is an eye irritant. No other effects requiring specific user protection measures were identified. The FEEDAP Panel concludes that use of FormiTM LHS would not pose a risk for the environment. The results from three of four studies show that supplementing sows' diets with FormiTM LHS has some effects directly on sows (increase in feed intake in two studies) or indirectly on litter's performance (increase in daily litter weight gain in two studies and an increase in weaning weight in another study). The data support a potential for efficacy at the highest proposed level (1.2%) over the period from one week before farrowing until weaning of piglets. The efficacy of the product at the lowest proposed dose (0.8%) is not demonstrated. No negative effects on meat quality would be expected from the use of FormiTM LHS in sows' feed at the proposed dose range

Scientific opinion on the safety and efficacy of MycoCell (Saccharomyces cerevisiae) for dairy cows

The microbial additive MycoCell is a preparation of viable cells of Saccharomyces cerevisiae. It is intended to be applied daily in dairy cows as a top dressing, or incorporated into a total mixed ration to provide 1*1010 CFU/head/day. The active agent, Saccharomyces cerevisiae, is considered by EFSA to have QPS status and, as such, can be presumed as safe for the target species, the consumers and the environment. The additional experimental data provided in support of safety for dairy cows and the genotoxicity data do not conflict with the conclusions reached on safety using the QPS approach. The additive has been unexpectedly shown to be a skin sensitiser. Given this result and in the absence of information on dusting potential, the product should also be treated as a respiratory sensitiser. In addition, it should be noted that the product is intended for top dressing at farm level. There is insufficient evidence that MycoCell at 1*1010 CFU/head/day improves production parameters in dairy cows

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

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver an opinion on the safety for the target animals and consumers of MintrexMn as nutritional additive for all species taking into account the earlier opinions on the product and the supplementary data provided by the applicant. Tolerance studies in piglets, laying hens and calves for rearing were submitted. In piglets, effects of manganese on hematological and biochemical parameters were observed, irrespective of the manganese source. In laying hens there was sufficient evidence to conclude that zootechnical parameters were unaffected by the manganese supplementation and source at an overdose. In calves for rearing there were no indications to suggest that MintrexMn is less safe compared to manganese sulfate. Taking also into account the already assessed safety of MintrexMn for chickens for fattening, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that MintrexMn is safe for all species up to the maximum total manganese content authorised in feed. MintrexMn did not induce significant changes in manganese deposition in edible tissues and products (piglet muscle, liver and kidney; hen's eggs; cow's milk) compared with already authorised inorganic manganese sources. Therefore, an increased manganese exposure of the consumers due to the use of MintrexMn is not expected. The FEEDAP Panel concludes that the use of MintrexMn up to the maximum authorised total manganese content in complete feeds is safe for consumers

Scientific Opinion on modification of the terms of authorisation of a red carotenoid-rich bacterium Paracoccus carotinifaciens (Panaferd-AX) as feed additive for salmon and trout

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on a modification to the terms of authorisation of a red carotenoid-rich bacterium Paracoccus carotinifaciens (Panaferd-AX) as feed additive for salmon and trout. The red carotenoid-rich bacterium Paracoccus carotinifaciens is authorised as a sensory additive for use in salmon and trout with a maximum content of 100 mg, expressed as the sum of astaxanthin, adonirubin and canthaxanthin per kg complete feed. The current carotenoid composition of the product is specified as 3-5 g canthaxanthin, 10-15 g adonirubin and 20-23 g astaxanthin/kg. The applicant proposes to modify the ranges of canthaxanthin to 1-5 g, and that of adonirubin to 7-15 g/kg product, while maintaining the astaxanthin range. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that adjusting the ranges for canthaxanthin and adonirubin to the values proposed by the applicant would not affect safety and efficacy of the product, considering that there are no changes in (i) the manufacturing of the product compared to the former application, and (ii) the conditions of use already authorised. The applicant provided data of 70 batches to substantiate his proposal. Fourteen batches did not meet the specification for astaxanthin (below 20 g/kg product). The content of canthaxanthin and adonirubin of the remaining batches did not support the ranges as proposed by the applicant. However, reviewing the carotenoid composition, compliance with ranges of 2-5 g canthaxanthin/kg and 9-15 g adonirubin/kg product has been obtained. The FEEDAP Panel noted that any extension of the range of the specified carotenoid contents would increase the uncertainties of the feed manufacturer when using the product