The eSS rat, a nonobese model of disordered glucose and lipid metabolism and fatty liver

<p>Abstract</p> <p>Background</p> <p>eSS is a rat model of type 2 diabetes characterized by fasting hyperglycemia, glucose intolerance, hyperinsulinemia and early hypertriglyceridemia. Diabetic symptoms worsen during the second year of life as insulin release decreases. In 12-month-old males a diffuse hepatic steatosis was detected. We report the disturbances of lipid metabolism of the model with regard to the diabetic syndrome.</p> <p>Methods</p> <p>The study was conducted in eight 12-month-old eSS male rats and seven age/weight matched eumetabolic Wistar rats fed with a complete commercial diet <it>al libitum</it>. Fasting plasmatic glucose, insulin, triglycerides, total cholesterol, low-density and high-density lipoprotein, and nonesterified fatty acids levels were measured. Very low density and intermediate-density lipoproteins were analyzed and hepatic lipase activity was determined.</p> <p>Results</p> <p>eSS rats developed hyperglycemia and hyperinsulinemia, indicating insulin resistance. Compared with controls, diabetic rats exhibited high plasmatic levels of NEFA, triglycerides (TG), total cholesterol (Chol) and LDL-Chol while high-density lipoprotein (HDL) cholesterol values were reduced. eSS rats also displayed TG-rich VLDL and IDL particles without changes in hepatic lipase activity.</p> <p>Conclusion</p> <p>The nonobese eSS rats develop a syndrome characterized by glucose and lipid disorders and hepatic steatosis that may provide new opportunities for studying the pathogenesis of human type 2 diabetes.</p

Safety and efficacy of muramidase from Trichoderma reesei DSM 32338 as a feed additive for turkeys for fattening, turkeys reared for breeding, chickens reared for breeding and other poultry species reared for breeding

Following a request from the European Commission, the Panel&nbsp;on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of muramidase produced by Trichoderma&nbsp;reesei DSM 32338. The additive is considered safe for turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding up to the maximum recommended dose of 45,000&nbsp;LSU(F)/kg feed. The additive is considered safe for the consumer and the environment. No conclusions can be reached on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive should be considered a potential respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive in turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding when added to feed at 25,000&nbsp;LSU(F)/kg feed

Assessment of the application for renewal of authorisation of l-arginine produced by fermentation using Corynebacterium&#160;glutamicum NITE SD 00285 for all animal species

l-Arginine is an amino acid that is conditionally essential for mammalian neonates, some strict carnivores, birds and fish. The subject of this opinion is a request for renewal of authorisation of l-arginine produced by a strain of Corynebacterium&nbsp;glutamicum. The strain designation has changed to its new deposition number, NITE SD 00285, but the strain is otherwise unchanged from the previous opinion. It is not genetically modified and possesses no antibiotic resistance of safety concern. Minor changes in downstream processing following fermentation have been made. The FEEDAP Panel&nbsp;notes that two out of five batches did not meet the specification of the current authorisation (minimum 98% on a dry matter basis). The FEEDAP Panel&nbsp;concludes that l-arginine produced by fermentation to C.&nbsp;glutamicum NITE SD 00285 remains safe for the target species, consumers of products from animals fed the additive and the environment under the approved conditions of authorisation. The additive is considered as irritant to skin, corrosive to eyes and poses a risk by inhalation

Efficacy of the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) CECT 8350 and Limosilactobacillus reuteri (formerly Lactobacillus reuteri) CECT 8700 (AQ02) for suckling piglets (Aquilon Cyl S.L.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) CECT 8350 and Limosilactobacillus reuteri (formerly Lactobacillus reuteri) CECT 8700 (AQ02) as a zootechnical feed additive for suckling piglets. In a previous opinion the FEEDAP Panel concluded that the additive is considered safe for the target species, the consumer, and the environment. The Panel concluded that the additive should be considered a respiratory sensitiser but could not conclude on the skin/eye irritation potential or on its skin sensitisation potential. The Panel previously could not conclude on the efficacy of AQ02. The applicant has provided supplementary information to support the efficacy of the additive in suckling piglets. Based on the data provided, the FEEDAP Panel could not conclude on the efficacy of the additive

Assessment of the application for renewal of authorisation of Biosprint&#174; (Saccharomyces&#160;cerevisiae MUCL 39885) for sows

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the product Biosprint\uae (Saccharomyces&nbsp;cerevisiae MUCL 39885) as a feed additive for sows. S.&nbsp;cerevisiae is considered by EFSA to have qualified presumption of safety (QPS) status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel&nbsp;on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel&nbsp;confirms that the use of Biosprint\uae under the current authorised conditions of use is safe for sows, the consumers and the environment. The additive is considered as a potential skin and eye irritant and skin/respiratory sensitiser. There is no need to assess the efficacy of Biosprint\uae in the context of the renewal of the authorisation

Assessment of the application for renewal of authorisation of Bactocell&#174; (Pediococcus acidilactici CNCM I-4622) as a feed additive for weaned piglets, pigs for fattening, minor porcine species (weaned and for fattening), chickens for fattening, laying hens and minor avian species for fattening and for laying and its extension of use to all growing pigs and all avian species

Following a request from the European Commission, the Panel&nbsp;on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on Bactocell\uae (Pediococcus acidilactici CNCM I-4622) in the context of the renewal of the authorisation for weaned piglets, pigs for fattening, minor porcine species (weaned and for fattening), chickens for fattening, laying hens and minor avian species for fattening and for laying when used as a zootechnical feed additive (gut flora stabiliser) in feed or in water for drinking. In addition, the applicant requested the extension of use for suckling piglets, minor pig species (growing/for fattening), chickens reared for laying, chickens reared for breeding purposes, chickens for breeding purposes, turkeys and minor avian species (including non-food producing/ornamental birds) reared for laying/breeding purposes and for breeding purposes when used as in feed or in water for drinking. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The additive is safe for the target species, consumers and the environment as well. The additive is non-irritant to skin and eyes and is not a dermal sensitiser but should be considered a respiratory sensitiser. Considering the high dusting potential of the formulations, exposure of users by inhalation is very likely. The additive, at the level of 1&nbsp; 7&nbsp;109&nbsp;CFU/kg feed (5&nbsp; 7&nbsp;108 when delivered in water), has the potential to be efficacious in the new species proposed: chickens reared for laying, chickens reared for breeding purposes, chickens for breeding purposes, turkeys and minor avian species reared for laying/breeding purposes and for breeding purposes (including non-food producing/ornamental birds) and in suckling piglets and minor porcine species (growing/for fattening)

Guidance on the assessment of the safety of feed additives for the environment

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No&nbsp;1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment. (Table presented.)

Safety and efficacy of OptiPhos\uae PLUS for suckling and weaned piglets, pigs for fattening, sows, other minor pig species for fattening and other minor reproductive pig species

Following a request from the European Commission, the EFSA Panel&nbsp;on Additives and products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of OptiPhos\uae PLUS (6-phytase) as a zootechnical feed additive for suckling and weaned piglets, pigs for fattening, sows, other minor pig species for fattening and other minor reproductive pig species. The additive is a preparation of 6-phytase produced by a genetically modified strain of Komagataella phaffii and has been previously assessed by the FEEDAP Panel&nbsp;in the context of two applications for its use in different species/categories. The Panel&nbsp;concluded in those opinions that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be skin irritant but was found to be a dermal sensitiser. The FEEDAP Panel&nbsp;could not conclude on the eye irritation potential of the additive. Owing to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. Based on the tolerance studies provided, the Panel&nbsp;concluded that the additive is safe for the target species under the conditions of use with a wide margin of safety and therefore the conclusion were extended to suckling piglets and extrapolated to other minor pig species for fattening and to other minor reproductive pig species. The FEEDAP Panel&nbsp;concluded that the additive has the potential to be efficacious in weaned piglets, pigs for fattening and in sows at the level of 250 FTU/kg feed and this conclusion were extended to suckling piglets and extrapolated to other minor pig species for fattening and to other minor reproductive pig species