60 research outputs found
Safety and efficacy of Levucell® SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for all pigs
No full textFollowing 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 Levucell® SB when used in feed for suckling piglets, pigs for fattening and minor porcine species. Levucell® SB is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae currently authorised as a zootechnical additive for weaned piglets, sows, chickens for fattening and minor poultry species for fattening. The applicant is now seeking authorisation as a zootechnical additive for use with all pigs. In the context of a previous opinion, the identity of the strain was confirmed, and according to the Qualified Presumption of Safety (QPS) approach to safety assessment, it was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell® SB is also considered safe for the target species, including all pigs, consumers and the environment. Levucell® is not a skin or eye irritant or a skin sensitiser. Inhalation exposure is unlikely. Encapsulation used in the existing coated forms is not expected to introduce hazards for users. In previous opinions, Levucell® SB was found to have the potential to be efficacious in sows and weaned piglets at the dose of 1 9 109 colony forming units (CFU)/kg complete feedingstuffs. Since the dose proposed for use with all pigs is the same as that demonstrated to be effective in weaned piglets and sows, and it can be reasonably assumed that the mode of action is the same, the conclusion on efficacy for weaned piglets and sows can be extrapolated to all pigs. Therefore, the FEEDAP Panel concludes that Levucell® SB has the potential to be efficacious in all pigs at 1 9 109 CFU/kg feedingstuffs
Experimental Assessment of the Environmental Fate and Effects of Triazoles and Benzotriazole
No full textThe environmental fate and effects of triazoles and benzotriazoles are of concern within the context of chemical regulation. As part of an intelligent testing strategy, experimental tests were performed on endpoints that are relevant for risk assessment. The experimental tests included the assessment of eco-toxicity to an alga, a daphnid and zebrafish embryos, and the assessment of ready biodegradability. Triazole and benzotriazole compounds were selected for testing, based on existing toxicity data for vertebrate and invertebrate species, as well as on the principal component analysis of molecular descriptors aimed at selecting the minimum number of test compounds in order to maximise the chemical domain spanned for both compound classes. The experimental results show that variation in the toxicities of triazoles and benzotriazole across species was relatively minor; in general, the largest factor was approximately 20. The study conducted indicated that triazoles are not readily biodegradable.</p
Modification of the terms of the authorisation of Natuphos® E as a feed additive for chickens for fattening or reared for laying/breeding
No full textThe additive Natuphos® E presents 6-phytase produced by a genetically modified strain of Aspergillus niger. The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets. The authorisation for chickens for fattening or reared for laying is at a minimum content of 750 FTU/kg feed. The applicant has requested to lower this dose to 125 FTU/kg feed. The Panel considered a total of three short-term trials and five long-term trials. In two short-term trials, the birds that received 125 FTU/kg feed showed a significantly better retention of phosphorus from the diets. Similarly, in two long-term trials, the birds that received 125 FTU/kg feed showed a significantly better performance. Consequently, the Panel concluded that the additive has a potential to improve the performance/phosphorus retention of the birds at the dose of 125 FTU/kg feed
Assessing bioaccumulation of polybrominated diphenyl ethers for aquatic species by QSAR modeling
No full textPolybrominated diphenyl ethers (PBDEs) are used as flame retardants in textiles, foams and plastics. Highly bioaccumulative with toxic effects including developmental neurotoxicity estrogen and thyroid hormones disruption, they are considered as persistent organic pollutants (POPs) and have been found in human tissues, wildlife and biota worldwide. But only some of them are banned from EU market.For the environmental fate studies of these compounds the bioconcentration factor (BCF) is one of the most important endpoints to start with. We applied quantitative structure–activity relationships techniques to overcome the limited experimental data and avoid more animal testing.The aim of this work was to assess the bioaccumulation of PBDEs by means of QSAR. First, a BCF dataset of specifically conducted experiments was modeled. Then the study was extended by predicting the bioaccumulation and biomagnification factors using some experimental values from the literature. Molecular descriptors were calculated using DRAGON 6. The most relevant ones were selected and resulting models were compared paying attention to the applicability domain.</p
Safety for the environment of vitamin D3 for salmonids
No full textThe Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment, the 2017 opinion did not address the potential effects of the proposed increase in the maximum authorised levels of vitamin D3 on the safety for the user and the environment. The NFSA has submitted additional data and the European Commission has requested EFSA to deliver a new opinion on the safety for the environment of vitamin D3 as a nutritional additive for salmonids. Planktonic microalgae, inhabiting the sea, are a large group of photosynthetic organisms that contain both vitamin D3 and provitamin D3. Marine phytoplankton is distributed throughout the sea serving as the basis for all marine food webs. Therefore, since it is produced by phytoplankton, vitamin D3 may also be considered as being ubiquitous in the aquatic environment. Considering the different sources of vitamin D3 already present in the marine environment, the FEEDAP Panel considers that an increase in concentration of vitamin D3 when used as a feed additive in compound feed for salmonids up to a maximum of 1.5 mg/kg is not expected to pose a risk for the environment
Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs
No full textFollowing a request from the European Commission, the 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 Lactobacillus reuteri NBF-1 when used in feed for dogs at a minimum dose of 6 9 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32203. This species is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety (QPS) approach establishing safety for the target species and the environment. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, in the absence of concerns from other components of the additive, Lactobacillusreuteri NBF-1 is presumed safe for the target animals and the environment. Lactobacillus reuteri NBF-1 should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or on its dermal sensitisation. The FEEDAP Panel is not in the position to conclude on the efficacy of Lactobacillus reuteri NBF-1 for dogs
Safety and efficacy of l‐valine produced by fermentation using Corynebacterium glutamicum KCCM 11201P for all animal species
No full textThe product subject of this assessment is L-valine produced by fermentation using a non-genetically modified strain of Corynebacterium glutamicum (KCCM 11201P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations below thresholds specified by EFSA, thus C. glutamicum KCCM 11201P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded % on ‘as is’ basis, and no impurities of concern were detected. The use of L-valine produced by C. glutamicum KCCM 11201P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. The product L- valine produced by C. glutamicum (KCCM 11201P) is considered not to be an irritant or a dermal sensitiser, and does not cause acute inhalation toxicity. The additive is an effective source of valine for all species. For the supplemental L-valine to be as efficacious in ruminants as in non-ruminant species, it requires protection against microbial degradation in the rumen
Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V
No full textFollowing a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on safety and efficacy of sodium molybdate dihydrate for sheep, based on a dossier submitted for the re-evaluation of the additive. The additive is currently authorised in the EU for all animal species as ‘Nutritional additive’ – ‘Compounds of trace elements’. Taking the optimal Cu:Mo ratio of 3–10, and the highest total copper level authorised in complete feeds for sheep (15 mg/kg), the FEEDAP Panel concluded that 2.5 mg total Mo/kg complete feed is safe for sheep. Considering (i) a safe intake of 0.6 mg Mo/day, (ii) the estimate average intake figure from food in Europe (generally less than 100 lg/day), (iii) the contribution of foods of animal origin to the total molybdenum intake (estimated to be up to 22 %), and (iv) that molybdenum would not accumulate in edible tissues/products of sheep fed molybdenum supplemented diets up to the upper safe level, the FEEDAP Panel concluded that the use of sodium molybdate as a additive in sheep at 2.5 mg total Mo/kg complete feed is safe for consumers. The additive under assessment feed poses no risk by inhalation to users; it is a skin and eye irritant, but it is not considered as a skin sensitiser. Sodium molybdate used up to 2.5 mg Mo/kg complete sheep feed poses no concerns for the safety for the environment. The FEEDAP Panel recognises that molybdenum does not need to be added to diets to cover the nutritional needs of molybdenum of sheep. Molybdenum supplementation in sheep feed is considered effective in order to guarantee an adequate balance with copper, when the Cu:Mo ratio in the diet is in the range 3–10
Safety and efficacy of Bonvital (Enterococcus faecium, DSM 7134) as an additive in water for drinking for sows
No full textThe additive Bonvital is a preparation of Enterococcus faecium authorised in feed for piglets and pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. The current authorisation in sows does not include the use of the additive in water for drinking. The additive is intended for use in water for drinking for sows at a minimum level of 2.5 x 10(8) colony forming unit (CFU)/L. This level is half of that minimum authorised in complete feed (5 x 10(8) CFU/kg), for the same target animals and would provide essentially the same exposure assuming that water consumption is approximately two- to three fold greater than feed consumption. Consequently, the conclusions on safety and efficacy of the additive when used in feedingstuffs also apply to its use in water for drinking for sows
Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying
No full textFollowing a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B-Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B-Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strain to be established and evidence that it is not toxigenic and does not show acquired resistance to relevant antibiotics. In a previous opinion, the strain was found to meet the criteria for the QPS approach. Since no concerns are expected from other components of the additive, B-Act® is presumed safe for the target species, consumers and the environment. In the same opinion, no conclusions could be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B-Act® was considered a potential respiratory sensitiser. Since the use of B-Act® with the target species is considered unlikely to introduce hazards for users of the product not already considered, the conclusions previously reached apply to the current application. B-Act® at the recommended dose of 1.6 9 109 colony forming units (CFU)/kg feed has the potential to be efficacious in turkeys for fattening. Since the same dose is proposed for the minor poultry species for fattening or raised for laying, the conclusions can be extended/extrapolated to these species. The conclusions on the compatibility of B-Act® with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal/lower than those for chickens
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