Safety and efficacy of a natural mixture of dolomite plus magnesite and magnesium-phyllosilicates (Fluidol) as feed additive for all animal species

The additive, a natural mixture of dolomite plus magnesite and magnesium-phyllosilicates, is intended to be used as a technological additive (functional groups: anticaking agents) in feedingstuffs for all animal species. The additive is safe in complete feed for dairy cows, piglets and pigs for fattening at a maximum concentration of 20,000 mg/kg. No conclusions can be drawn for all the other animal species/categories. The additive is not genotoxic. As the additive is essentially not absorbed from the gut lumen, the Panel on Additives and Products or Substances used in Animal Feed considers that use of the additive in animal nutrition is safe for consumers of food products from animals fed diets containing the additive. The additive is not an irritant to the eyes and the skin, it is not a skin sensitiser and it is of low toxicity by the inhalation route. The components of the additive (dolomite, magnesite, talc and chlorite) are natural constituents of soil. Consequently, the use of the additive in animal nutrition will not pose a risk to the environment. The additive is effective as an anticaking agent at a minimum inclusion level of 5,000 mg/kg feed

Safety and efficacy of L arginine produced by Corynebacterium glutamicum KCTC 10423BP for all animal species

L-Arginine is considered as a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The following conclusions refer to L-arginine produced by Corynebacterium glutamicum KCTC 10423BP. The use of L-arginine is safe for target species when supplemented to diets in appropriate amounts. There are no safety concerns arising from ruminal L-arginine metabolism. The composition of edible tissues and products of animal origin will not be altered by the use of L-arginine in animal nutrition. Considering the high purity of the product under assessment, no risk is expected for the consumer from the use of L-arginine as a feed additive. L-Arginine is not irritating to skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, there is evidence of no acute toxicity by the inhalation route. The use of L-arginine in animal nutrition would not pose a risk to the environment. Dietary L-arginine is an effective source of arginine for all animal species when a requirement exists. For the supplemental L-arginine to be fully efficacious in ruminants, it requires protection against degradation in the rumen

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 Lactobacillus plantarum NCIMB 42150 as a silage additive for all animal species

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 a specific strain of Lactobacillus plantarum when used as a technological additive intended to improve ensiling at a proposed application rate of 1 9 108 colony forming unit (CFU)/kg fresh material. L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than demonstrating the absence of resistance to antibiotics of human and veterinary significance. As the identity of the strain was clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed treated silage and the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Five studies with laboratory-scale silos were made using forage of differing water-soluble carbohydrate content. Replicate silos containing forages treated at the proposed application rate were compared to identical silos containing the same but untreated forage. In addition, in four studies, formic acid was included as positive control. The mini-silos were then stored for 90\u2013103 days at 20\u201324\ub0C. After opening, the contents of the silos were analysed. Results showed that this strain of L. plantarum has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage species by increasing the production of lactic acid, reducing the pH and increasing the preservation of dry matter when used at an application rate of 1 9 108 CFU/kg

Safety of Allura Red AC in feed for cats and dogs

No evidence of genotoxicity was found in an in vivo micronucleus test with Allura Red AC; however, no evidence of target cell exposure was provided. In an in vivo comet assay, Allura Red AC was clearly negative for the induction of DNA damage in all the analysed tissues (stomach, colon, and liver). Consequently, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that Allura Red AC is not genotoxic. Since no data on the safety of Allura Red AC for cats and dogs were provided, the highest safe dietary concentration of Allura Red AC was derived from the no observed adverse effect level obtained in toxicity studies with rats, applying an uncertainty factor of 100. The calculated values were 370 mg/kg complete feed for dogs and 308 mg/kg complete feed for cats

Safety and efficacy of polyoxyethylene (20) sorbitan monooleate as a feed additive for all animal species

The additive is a mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides. It contains a minimum of 65% of oxyethylene groups, equivalent to not less than 96.5% of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis and less than 3% water. The following concentrations of polyoxyethylene (20) sorbitan monooleate per kg complete feedingstuffs are considered safe: 1,260 mg for salmonids, 1,100 mg for cattle for fattening, 830 mg for pigs for fattening and sows, 750 mg for turkeys for fattening, 720 mg for dairy cows, 500 mg for piglets, 420 mg for chickens for fattening and laying hens, 1,320 mg for dogs and 1,100 mg for cats; and 5,000 mg/kg milk replacer are considered safe for calves. The use of polyoxyethylene (20) sorbitan monooleate as feed additive for all animal species at the maximum concentration proposed of 5,000 mg/kg complete feedingstuffs would not raise concerns for the consumer. Polyoxyethylene (20) sorbitan monooleate is non-irritant to skin and eyes, and is not a skin sensitiser. There is evidence that dermal or oral exposure to the additive can exacerbate the symptoms in individuals who are already sensitised. Users are unlikely to be exposed to the additive by inhalation. The lack of data and the inherent uncertainties do not allow concluding on the safety for the environment. Polyoxyethylene (20) sorbitan monooleate is a recognised emulsifier used in food and it is expected to have the same effect when applied to feed. From the practical examples provided, polyoxyethylene (20) sorbitan monooleate appears to be effective in aiding and maintaining the homogeneous distribution of feed materials and/or additives in feedingstuffs

Safety and efficacy of RONOZYME® NP (6‐phytase) as a feed additive for pigs for fattening

The additive RONOZYME\uae NP is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. This product is authorised in the European Union as a feed additive for poultry, weaned piglets, pigs for fattening and sows. The authorisation of RONOZYME\uae NP for use in pigs for fattening is at a minimum dose of 1,500 FYT/kg feed (recommended range 1,500\u20133,000 FYT/kg feed). The applicant requested to modify the terms of the authorisation for this species/category of animals, by lowering the minimum recommended dose from 1,500 to 1,000 FYT/kg feed. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded in previous assessments that the additive is safe for the target species, the consumers and the environment, and that the solid forms of the additive are regarded as dermal and eye irritants and all forms are assumed to be respiratory sensitisers. The reduction in the dose proposed would not change the previous conclusions regarding the safety for the target animals, consumer, user and environment. Three trials carried out with growing pigs were submitted in order to support the efficacy at the new recommended dose. In all the trials faecal apparent digestibility of phosphorus was measured, retention was measured only in one trial. The demonstration of efficacy for a phytase requires three studies showing positive and significant effects on the retention of phosphorus. In the trials submitted, the phosphorus retention was studied only in one trial; consequently the efficacy at the newly recommended dose was not demonstrated

Safety and efficacy of BIOSTRONG® 510 (essential oil of thyme and star anise) for chickens and minor avian species for fattening and rearing to point of lay

Following 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 the product BIOSTRONG\uae 510 (essential oil from thyme and star anise, crushed dried spices and crushed dried herbs), when used as a feed additive for chickens for fattening and rearing to point of lay and minor avian species for fattening and rearing to point of lay. BIOSTRONG\uae 510 is a preparation of partially microencapsulated essential oils from thyme and star anise, dried herbs and dried spices. The FEEDAP Panel concludes that BIOSTRONG\uae 510 is safe for chickens for fattening at the proposed conditions of use and that this conclusion can be extended to chickens reared for laying and extrapolated to all minor poultry species for fattening and reared to point of lay. The FEEDAP Panel concludes that the use of BIOSTRONG\uae 510 as an additive in the feed for chickens for fattening does not present risk for the consumer of meat and meat products. Irritancy studies have not been provided, however, because of the content of saponins, the FEEDAP Panel assumes that the additive is highly irritant to mucous membranes, and considers that measures to minimise exposure by all routes are necessary for the handling of this product. The use of BIOSTRONG\uae 510 at the recommended levels is not considered to be a risk for the environment. The FEEDAP Panel considers that BIOSTRONG\uae 510 has the potential to be efficacious in improving performance of chickens for fattening. This conclusion can be extended to chickens reared for laying and extrapolated to all minor poultry species for fattening and reared to point of lay at the same dose