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Safety and efficacy of a feed additive consisting of chromium chelate of dl-methionine (Availa® Cr) for all finfish (Zinpro Animal Nutrition Europe, Inc.)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of chromium chelate of dl-methionine (Availa® Cr) for all finfish. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for salmonids at the maximum proposed use level of 600 mg additive/kg complete feed (corresponding to 0.6 mg Cr/kg complete feed). The FEEDAP Panel was not in the position to conclude on the safety of the use of Availa® Cr in feed for other finfish. The use of the additive in finfish feed at the maximum proposed use level was considered safe for the consumer and for the environment. Regarding user safety, the FEEDAP Panel concluded that the additive is not an eye nor skin irritant, but due to the presence of nickel, the additive is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel concluded that the additive has the potential to be efficacious in salmonids at 0.2 mg Cr/kg complete feed, and in other finfish at 0.5 mg Cr/kg complete feed.</p
Safety and efficacy of a feed additive consisting of Enterococcus lactis NCIMB 10415 for all animal species (Agri-King, Inc.)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Enterococcus lactis NCIMB 10415 when used as a technological additive to improve ensiling of all types of fresh plant material for all animal species at a proposed minimum level of 1 × 108 colony forming units (CFU)/kg fresh plant material. The strain NCIMB 10415 was unambiguously identified as Enterococcus lactis, found not to belong to the hospital-associated clade of Enterococcus faecium and acquired antimicrobial resistance genes were not detected. Consequently, the FEEDAP Panel concluded that E. lactis NCIMB 10415 is safe for all animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding the safety for the user, the additive is considered irritant to eyes and a skin and respiratory sensitiser. Therefore, any exposure is considered a risk. The FEEDAP Panel concluded that the addition of E. lactis NCIMB 10415 at a minimum level of 1 × 108 CFU/kg to fresh plant material has the potential to improve the production and fermentation quality of silage made from all types of plant materials.</p
Efficacy of feed additives obtained from the leaves of Ginkgo biloba L.: Ginkgo tinctures for all animal species and ginkgo extract for horses, dogs, cats, rabbits and guinea pigs (FEFANA asbl)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of feed additives obtained from the leaves of Ginkgo biloba L.: ginkgo tinctures as sensory additives for all animal species and ginkgo extract as a sensory additive for horses, dogs, cats, rabbits and guinea pigs. In previous assessments, a sensory analysis of ginkgo extract was performed, which showed that aqueous solutions of ginkgo extract have an intense aroma, significantly different from plain water. No evidence was provided to show that the additives would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel could not conclude on the efficacy of the additives. The applicant provided new efficacy studies, which showed that the addition of the additives under assessment (ginkgo extract and ginkgo tinctures) led to detectable flavour changes to a food matrix under the experimental conditions tested. The FEEDAP Panel considers that ginkgo extract and ginkgo tinctures have the potential to be efficacious as sensory additives in feed.</p
Efficacy of a feed additive consisting of 6-phytase produced by (Komagataella phaffii CGMCC 7.370) (VTR-phytase) for all pigs and growing poultry species (Victory Enzymes GmbH)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6-phytase produced by Komagataella phaffii CGMCC 7.370 (VTR-phytase) as a zootechnical feed additive for all pigs and growing poultry species. The additive is intended to be commercialised in two formulations: liquid and powder. In a previous opinion the FEEDAP Panel concluded that the additive is safe for target species, consumers and environment. The FEEDAP Panel deemed that both formulations of the additive are not skin and eyes irritant but should be considered skin and respiratory sensitisers. The FEEDAP Panel concluded that VTR-phytase has potential to be efficacious in laying hens at 1000 U phytase/kg complete feed, and this conclusion was extended to all laying and reproductive poultry. However, due to the lack of sufficient data, the Panel was not in a position to conclude on the efficacy for poultry for fattening or reared for laying/breeding, and in any porcine species. The applicant provided new trials to support the efficacy of the additive on those target species. Based on the data provided in the previous and current application, the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for all poultry for fattening and reared for laying/breeding and reproductive porcine species at 500 U phytase/kg complete feed and all porcine species for fattening and reared for reproduction at 750 U phytase/kg complete feed.</p
Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit & GalliPro® Fit 10) for all poultry (Chr. Hansen A/S)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 32324, B. subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit 10) as a zootechnical feed additive for all poultry species. The additive in a less concentrated form (GalliPro® Fit) is already authorised for use in feed and water for drinking for poultry for fattening, reared for laying or reared for breeding. With the current application, the applicant is seeking the authorisation for use in feed and water for drinking for all poultry. In addition, the applicant is seeking the modification of the terms of the existing authorisation by introducing a new formulation with a 10-fold increased concentration of the active agents in the additive (from 3.2 × 109 to 3.2 × 1010 colony forming units (CFU)/g additive). The FEEDAP Panel concluded that the additive is considered safe for the target species, including poultry species for laying and breeding, consumers and the environment at the proposed conditions of use. Both forms of the additive are non-irritant to the eyes but are considered skin and respiratory sensitisers, and any exposure through skin and respiratory tract is considered a risk. The additive has the potential to be efficacious as a zootechnical additive in all poultry at 1.6 × 109 CFU/kg feed and 5.4 × 108 CFU/L water for drinking.</p
Safety and efficacy of a feed additive consisting of 25-hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for salmonids, other fish species and all other animal species (except poultry, pigs and all ruminants) (DSM Nutritional Products Ltd.)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 25-hydroxycholecalciferol as a nutritional feed additive for salmonids, other fish species and all other animal species (except poultry, pigs and all ruminants). The additive is currently authorised for use in pigs, poultry and ruminants. The additive is safe for salmonids, other fish species and all other animal species (other than pigs, poultry and ruminants) at the maximum recommended use levels (in mg 25-OH-D3/kg complete feed): 0.8 for salmonids, 0.075 in other fish species and 0.05 for all other animal species (other than poultry, pigs and ruminants). The use of 25-OH-D3 in feed for all animal species under the proposed conditions of use is considered safe for the consumers and the environment. With regard to the safety of users, the additive is not irritant to the skin or eyes. No conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to the absence of data. The FEEDAP Panel concludes that 25-OH-D3, when used as a nutritional additive in feed, is efficacious for all animal species.</p
Decimated in linear time; single power trace, full key recovery attack on Toeplitz hash privacy amplification
We demonstrate a template power side channel attack that recovers the full secret key on an implementation of a radix-2 Decimation in Time Fast Fourier Transform (DIT-FFT) optimised Toeplitz Hashing based privacy amplification, commonly used in quantum key distribution. The duration of the attack is linear in time with respect to the input key length when the target platform is an ARM Cortex-M4 and is successful with a single power trace. We demonstrate that key leakage is present in an Artix-7 FPGA power trace, but high noise makes a single trace attack difficult
My Diabetes and Me: Study protocol for a randomised controlled trial to test the clinical and cost-effectiveness of a diabetes self-management education programme for adults with intellectual disabilities
BackgroundInternational guidelines recommend structured diabetes education to empower individuals with type 2 diabetes (T2D). While DESMOND is an effective programme for T2D management, it is often inaccessible to people with intellectual disabilities (ID) due to their unique needs. There is limited evidence on the effectiveness of adapted T2D education for this group, despite the importance of tailored support in preventing complications and early mortality. We previously adapted the DESMOND programme for adults with ID, creating DESMOND-ID. A feasibility study showed it is possible to recruit and deliver the programme to adults with ID and their carers, who found it valuable. Initial findings suggest DESMOND-ID may improve blood glucose control, warranting further investigation through a large-scale randomised controlled trial (RCT).MethodsThe "My Diabetes & Me" study will be conducted in two stages: an internal pilot and a main RCT. The pilot will recruit 108 participants over 10 months to assess recruitment and retention, using glycated haemoglobin (HbA1c, mmol/mol) at six months as the primary outcome. This will inform the design of the main study. Across both stages, 450 participants will be randomly assigned to receive either the DESMOND-ID intervention or treatment as usual (TAU). The intervention group, with their carers, will attend weekly sessions for seven weeks, plus two booster sessions at one and three months post-programme. Primary outcome is HbA1c at six months. Secondary outcomes include HbA1c at 12 and 18 months (pilot only), anthropometric data, self-reported outcomes, and other risk factors. A process evaluation will explore barriers and facilitators to implementation using qualitative and quantitative methods.ConclusionDESMOND-ID is the first structured T2D education programme tailored for adults with ID, and this RCT is the first to evaluate its clinical and cost-effectiveness