Safety and efficacy of methylester of conjugated linoleic acid (t10,c12 isomer) for pigs for fattening, sows and cows

A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions was not genotoxic and caused no reproductive toxicity. In a sub-acute study in dogs, a sub-chronic toxicity study in rats and a chronic study in dogs, no adverse effects were seen up to the highest levels tested. The maximum recommended feed concentration (5 g CLA (t10,c12)-ME from Lutalin (R)/kg feed for piglets, pigs for fattening and sows) or dose (30 g CLA (t10,c12)-ME from Lutrell (R) Pure/cow per day) is considered safe for target species. The CLA content of milk from cows treated with the highest recommended dose did not exceed background values (in milk of untreated cows) for both CLA isomers. An estimate of consumer exposure to both CLA isomers from food from pigs receiving 3 g of both CLA isomers/kg feed is <= 320 mg CLA isomers/person and day. This quantity corresponds to about 9% of the quantity considered safe for 6 months and is considered unlikely to raise concerns for consumer safety. Exposure of users by inhalation of the additive is likely to be minimal. Neither of the products under application, the liquid or the solid product, was tested as such for skin and eye irritation and skin sensitisation. The use of the additive in animal nutrition would not pose a risk to the environment. In pigs for fattening, CLA (t10,c12)-ME has a potential for improving feed to gain ratio. More consistent effects are a reduction in subcutaneous fat, an increase in intramuscular fat and fat firmness. No essential effects were found in sows. Administration of CLA to dairy cows reduces in a dose-dependent manner the fat content of milk, and milk fat yield. Energy balance in early lactation is improved by CLA (t10,c12)-ME; however, reproductive parameters were not influenced

Safety and efficacy of lactic acid and calcium lactate when used as technological additives for all animal species

This opinion concerns the re-authorisation of lactic acid and calcium lactate for use as preservatives in feed and a new authorisation for lactic acid as a preservative in water for drinking. The maximum level of 50 000 mg lactic acid/kg complete feed and 30 000 mg calcium lactate/kg complete feed are considered safe for functional ruminants and pigs. The maximum safe concentration in water for drinking for pigs can be derived from the maximum safe level in feed (15 000 mg lactic acid/L water). No conclusions on the safety of lactic acid in pre-ruminants and poultry can be drawn. These conclusions cannot be extrapolated to other animal species/categories. The use of lactic acid and calcium lactate as feed additives is safe for the consumer. Lactic acid is considered an irritant to eyes and skin and there is a risk of serious damage to the eyes. Inhalation of the mist causes irritation of the respiratory system. Calcium lactate should be considered an irritant to skin, eyes and the respiratory tract. It is likely that handling the additive will result in the production of respirable dust, which could present a risk to unprotected workers. The use of lactic acid and calcium lactate in animal nutrition would not pose a risk to the environment, provided that the concentrations regarded as safe for the target species are not exceeded. Lactic acid and calcium lactate are used in food as preservatives. It is reasonable to expect that the effect seen in food will be observed in feed when these additives are used at comparable concentrations and under similar conditions. However, the Panel has reservations about the effectiveness of lactic acid and calcium lactate as preservatives in complete feedingstuffs with a typical moisture content of <= 12 %

Safety and efficacy of Calsporin((R)) (Bacillus subtilis DSM 15544) as a feed additive for laying hens and avian species for laying EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

The additive Calsporin (R) is a preparation containing viable spores of a single strain of Bacillus subtilis. The product was previously assessed by the European Food Safety Authority and is currently authorised for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds. The present application is for an extension of use in feed for laying hens and minor avian species for laying and for game, sporting and ornamental birds for laying. No evidence of toxigenic potential or resistance to antibiotics of human and veterinary importance was found, as judged by the current guidelines. Thus the conclusion reached in previous opinions that this strain of B. subtilis is presumed safe for target animals, consumers and the environment is still considered valid. This conclusion automatically covers the use of the additive in feed for laying hens and for all avian species for laying. Use of the additive in feed for laying hens and for all avian species for laying will not introduce hazards for users not already considered. In the three trials conducted with laying hens the amount of feed needed to produce a unit of egg mass was significantly reduced when Calsporin (R) was included at the minimum recommended dose of 3 x 10(8) colony-forming units per kilogram of feed. While the Panel notes that one of the studies involved layers in the second half of production rather than from the onset of laying, the positive outcome is taken to indicate a potential for efficacy over the entire laying period. This conclusion on efficacy for laying hens can be extended to all avian species for laying when the additive is used at the same minimum dose