Safety and efficacy of a feed additive consisting of Bifidobacterium longum CNCM I-5642 (PP102I) for cats and dogs (Nestlé Enterprises S.A.)

Following 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 Bifidobacterium longum CNCM I-5642 (PP102I) when used as a feed additive for cats and dogs. The product under assessment consists of viable cells of a strain of B. longum, a species considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The strain was unambiguously identified as B. longum and was shown not to harbour antimicrobial resistance determinants for antibiotics of human and veterinary importance, thus meeting the QPS requirements. Following the QPS approach to safety assessment and since no concerns are expected from maltodextrin, the other component of the additive, PP102I was considered safe for the target species and the environment. Owing to the lack of data, no conclusions could be drawn on the skin/eye irritancy potential of PP102I. However, it should be considered a skin and respiratory sensitiser. The Panel was not in the position to conclude on the efficacy of PP102I for the target species

Safety and efficacy of a feed additive consisting of pancreatin from porcine pancreas (Pan-zoot) for dogs (Almapharm GmbH + Co KG)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a pancreatic extract (Pan-zoot) as a zootechnical additive for dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of Pan-Zoot as a feed additive for dogs under the proposed conditions of use. The FEEDAP Panel could not conclude on the skin/eye irritancy potential of the additive or on the dermal sensitisation potential. Owing to its proteinaceous nature, the additive is considered a respiratory sensitiser. The additive may induce allergic reactions to the exposed users. The Panel concluded that there is no need for an environmental risk assessment. The FEEDAP Panel could not conclude on the efficacy of the product as a feed additive at the recommended conditions of use

Safety and efficacy of a feed additive consisting of 6-phytase produced by Trichoderma reesei CBS 146250 (Axtra® PHY GOLD 30L, Axtra® PHY GOLD 30T, Axtra® PHY GOLD 65G) for all poultry species and all pigs (Danisco (UK) ltd)

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 6-phytase produced by the genetically modified strain Trichoderma reesei CBS 146250 (Axtra® PHY GOLD 30L, Axtra® PHY GOLD 30 T and Axtra® PHY GOLD 65G) as a zootechnical feed additive for all poultry species and all pigs. The FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry species and all pigs at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not give rise to concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel cannot conclude on the potential of the additive to be irritant to eyes or skin. Due to the proteinaceous nature of the active substance, it is considered a respiratory sensitiser. The panel concludes that the additive is efficacious in increasing the phosphorus utilisation when supplemented at 500 FTU/kg for all growing poultry species and all pigs, and at 300 FTU/kg in laying hens and other laying birds

Design and Operationalization of Connectivist Activities: an Approach through Business Process Management

International audienceThe work presented in this paper focuses on massive open online course (MOOC) environments, and more specifically on the activity of designing and implementing pedagogical scenarios for a connectivist MOOC (cMOOC). This paper presents a research work, which aims to propose a model and tool to support the design of connectivist MOOC scenarios. The major contribution of this work is a visual authoring tool that is intended for the design and deployment of cMOOC-oriented scenarios. The tool is based on the BPMN notation that we have extended to suit our objectives. The tool was evaluated primarily from the point of view of utility and usability. The findings confirm that the tool can be used to design connectivist pedagogical scenarios and can provide all the necessary elements to operationalize such courses

Safety and efficacy of Levucell ® SB (Saccharomyces cerevisiae CNCM I-1079) as a feed additive for turkeys for fattening

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 Levucell \uae SB when used in feed for turkeys for fattening. The additive is intended for use as a zootechnical additive (functional group: other additives) for the reduction of Salmonella contamination on carcasses through its decrease in faeces. 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 and the environment. Since no concerns are expected from other components of the additive, Levucell \uae SB is also considered safe for the target species, consumers and the environment. The additive is not a skin or eye irritant or a skin sensitiser. Considering the data on the dusting potential, the user can be exposed to the additive by inhalation when handling it. The additive in non-encapsulated form should be considered as a respiratory sensitiser. The coated formulation is not considered to pose a risk by inhalation. The efficacy of Levucell \uae SB for the same purpose was previously established in chickens for fattening. The FEEDAP Panel concluded that there was some evidence that the addition of Levucell \uae SB at 2  7 10 10 CFU/kg feed has a potential to aid the reduction of carcass contamination with Salmonella spp. Since the mechanism of action of the additive can be reasonably assumed to be same, Levucell \uae SB can be presumed efficacious in turkeys for fattening at a dose of 2  7 10 10 CFU/kg feed without the need for additional studies

Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces 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 cerevisiae MUCL 39885) as a feed additive for sows. S. 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 on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel 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

Safety and efficacy of a feed additive consisting of disodium 5’-guanylate produced with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067 for all animal species (CJ Europe GmbH)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5’-guanylate produced by fermentation with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The additive does not raise safety concerns under the proposed conditions of use for the target species, consumers the users and the environment. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) expressed reservations on the use of the additive in water for drinking due to concerns on its impact on hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by Komagataella phaffii DSM 33574, and viable spores of Bacillus velezensis DSM 21836 and Bacillus licheniformis ATCC 53757 (EnzaPro) for chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and growing minor poultry species (BioResource International (BRI), Inc.)

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 EnzaPro containing viable cells/spores of strains of Bacillus velezensis (DSM 21836) and Bacillus licheniformis (ATCC 53757) and an endo-1,4-β-xylanase produced by a genetically modified strain of Komagataella phaffii (DSM 33574) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. The strains B. velezensis DSM 21836 and B. licheniformis ATCC 53757 were considered to meet the qualified presumption of safety (QPS) requirements. The K. phaffii xylanase production strain is genetically modified. No viable cells and no recombinant DNA of the genetically modified production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the xylanase production strain. EnzaPro is safe for all poultry species for fattening or reared to the point of lay at the proposed conditions of use. The FEEDAP Panel concluded that the use of EnzaPro in animal nutrition is safe for the consumers and the environment. EnzaPro is not a skin irritant but should be considered an eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. Due to the lack of data, the FEEDAP Panel could not conclude on the efficacy of EnzaPro for the target species. EnzaPro is compatible with diclazuril, halofuginone and nicarbazin

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 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 in the context of two applications for its use in different species/categories. The Panel 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 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 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 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