The European Commission's request prompted EFSA to deliver a scientific opinion on the safety of a tincture prepared from Gentiana lutea L. (gentian tincture). This sensory additive is designed for use with all types of animals. A water and ethanol solution comprises the product, containing approximately 43% dry matter, and an average of 0.00836% polyphenols (including 0.00463% flavonoids and 0.00027% xanthones), along with 0.00022% gentiopicroside. Complete feed and drinking water for all animals, excluding horses, can incorporate the additive up to a maximum dosage of 50 mg tincture per kilogram. For horses, a maximum of 200 mg per kilogram is allowed in complete feed. The FEEDAP panel's prior assessment on the safety of the additive for long-lived animals was inconclusive due to the in vitro genotoxic potential observed in xanthones (gentisin and isogentisin) and gentiopicroside. This also raised concerns regarding the genotoxicity and carcinogenicity risks related to dermal exposure for those lacking protection. Concerns about the safety of the additive for short-lived animals, consumers, and the environment were not raised. The applicant has submitted literature to explain the previously recognized genotoxic activity of xanthones and gentiopicroside, and to highlight the ensuing user risks. The FEEDAP Panel, observing no novel data in the cited literature, underscored its inability to ascertain the safety of the additive for long-lived and breeding animals. No findings emerged regarding the possibility of the additive causing dermal/eye irritation or acting as a skin sensitizer. Handling the tincture without proper protection could result in unprotected individuals being exposed to xanthones (gentisin and isogentisin) and gentiopicroside; this exposure cannot be prevented. Subsequently, to lessen the risk, a decrease in user exposure is vital.
USDA's dossier, submitted to the EFSA Panel on Plant Health by the European Commission, proposes using sulfuryl fluoride to treat Agrilus planipennis on ash log shipments for phytosanitary certification. Following the accumulation of supplementary data from USDA APHIS, external authorities, and scholarly sources, the Panel conducted a quantitative evaluation of the probability of A. planipennis pest absence at the EU's point of entry for two distinct commodities fumigated with sulfuryl fluoride: (a) ash logs with bark; and (b) ash logs without bark. Aticaprant supplier An expert evaluation estimates the chance of pest freedom, incorporating pest control measures and their associated uncertainties in the assessment. The presence of bark on ash logs correlates with a diminished chance of A. planipennis pest eradication compared to bark-free ash logs. The Panel is 95% confident that the proposed sulfuryl fluoride fumigation regime, as detailed by the USDA APHIS, will successfully eradicate A. planipennis from between 9740 and 10000 containers of ash logs with bark per 10000 and between 9989 and 10000 containers of debarked ash logs per 10000.
The European Commission's request prompted the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to provide a scientific opinion on the safety and effectiveness of riboflavin (vitamin B2), a product of Bacillus subtilis CGMCC 13326, as a nutritional additive suitable for application to all animal species. The additive's production is dependent on a genetically modified production strain's activity. Although the production strain holds genes that code for antimicrobial resistance, no viable cells or DNA from the production strain were present in the final product's composition. Subsequently, utilizing B. subtilis CGMCC 13326 in the biosynthesis of vitamin B2 does not give rise to safety concerns. Aticaprant supplier Riboflavin, 80% derived from *Bacillus subtilis* CGMCC 13326, poses no safety risk to target animals, consumers, or the environment when used in animal nutrition. In the current state of data collection, the FEEDAP Panel is unable to ascertain any conclusions regarding potential skin and eye irritation or the toxic effects of inhaling the assessed additive. The photosensitizing characteristic of riboflavin can result in photoallergic responses impacting skin and eyes. This additive, when used in animal feed, is being assessed for its ability to fulfill the animals' requirement for vitamin B2.
The European Commission directed EFSA to provide a scientific evaluation of the safety and efficacy of endo-14,d-mannanase (Hemicell HT/HT-L), produced by a genetically modified Paenibacillus lentus strain (DSM 33618), as a zootechnical feed additive intended for fattening chickens and turkeys, laying hens, breeding turkeys, minor poultry up to laying, fattening pigs, weaned piglets, and minor pig breeds. Aticaprant supplier The production strain was derived from a Paenibacillus lentus recipient strain, which had been previously evaluated by EFSA and found to be safe. Regarding the genetic modification, no safety concerns were identified, and the resultant production strain demonstrated an absence of antibiotic resistance genes introduced by the modification. In the intermediate product used to create the additive, there was no evidence of viable cells or DNA from the production strain. Under the intended conditions of use, Hemicell HT/HT-L, manufactured by Paenibacillus lentus DSM 33618, is deemed safe for the target species mentioned above. The inclusion of Hemicell HT/HT-L in livestock feed presents no problems for consumer well-being or ecological stability. While Hemicell HT/HT-L does not irritate the skin or eyes, it is considered a dermal sensitizer with the possibility of being a respiratory sensitizer. Chickens raised for fattening, laying, and minor poultry for fattening, laying, or breeding, pigs for fattening, and minor porcine species may benefit from the additive's potential efficacy at a dosage of 32,000 U/kg.
Hayashibara Co., Ltd. produces the food enzyme cyclomaltodextrin glucanotransferase ((1-4),d-glucan(1-4),d-glucan 4,d-[(1-4),d-glucano]-transferase; EC 24.119) using the non-genetically modified bacteria Anoxybacillus caldiproteolyticus strain TCM3-539. No live cells from the production strain are present. The food enzyme's intended application is the fabrication of glucosyl hesperidin and ascorbic acid 2-glucoside. Total organic solids' residual amounts are eliminated through filtration, adsorption, chromatography, and crystallization; hence, dietary exposure estimation is unnecessary. Analysis of the food enzyme's amino acid sequence for potential matches with known allergens yielded a result: a respiratory allergen. The Panel believed that, under the intended circumstances of consumption, the risk of allergic reactions via dietary means, while not impossible, is deemed improbable. The Panel's assessment, based on the data, indicated that the enzyme in question presents no safety hazards under its intended application conditions.
The EFSA Panel on Plant Health, acting for the EU, performed a categorization of the mango shield scale (Milviscutulus mangiferae, Hemiptera Sternorrhyncha Coccidae). Determining the natural range of M. mangiferae is a challenge. This species exhibits a broad distribution across tropical and warmer subtropical regions globally. Mango trees imported from Florida (USA) to the Botanical Garden of Padua's greenhouse in Italy have shown the pest's presence within the EU, although its permanence is still unclear. Within the confines of Annex II of Commission Implementing Regulation (EU) 2019/2072, this item is not recorded. Its polyphagous nature allows it to feed upon plant species belonging to over 86 genera and more than 43 families, comprising many crop and ornamental plants. This troublesome pest attacks mango trees (Mangifera indica) with vigor, and occasionally bothers a selection of ornamental plants. M. mangiferae's host list encompasses economically important EU crops, including citrus (Citrus spp.), avocado (Persea americana), and decorative plants, such as hibiscus (Hibiscus spp.) and myrtle (Myrtus communis). Generally, M. mangiferae reproduces through parthenogenesis, completing two to three generations within a single year. Cultivation-oriented plants, alongside cut flowers and fruits, offer a potential pathway for the introduction of non-EU species. The southern European climate, together with the abundance of host plants in those regions, provides ideal conditions for the establishment and dispersal of species. Establishment opportunities exist in heated greenhouses, particularly in the less temperate regions of the European Union. The introduction of the mango shield scale within the EU is expected to negatively affect the economy through a reduction in fruit and ornamental plant yields, quality standards, and their overall market value. To diminish the potential for introduction and subsequent propagation, phytosanitary procedures are accessible. To be deemed a potential Union quarantine pest, M. mangiferae must meet criteria within the scope of EFSA's evaluation.
The inverse correlation between AIDS-related mortality and morbidity and the growing prevalence of cardiovascular diseases (CVDs) and their risk factors is noteworthy in HIV patients. Various cardiovascular risk factors coalesce to form metabolic syndrome (MetS), a condition that increases the probability of subsequent cardiovascular diseases. We undertook a study to determine the presence of Metabolic Syndrome (MetS) and its linked risk factors across three categories of individuals: HIV patients currently receiving combination antiretroviral therapy (cART), HIV patients who have not yet initiated cART, and control subjects without HIV.
In a case-control study conducted at a periurban hospital in Ghana, the study population included 158 cART-treated HIV patients, 150 cART-naive HIV patients, and 156 non-HIV controls. A structured questionnaire was implemented for the purpose of gathering data on participants' demographics, lifestyle, and any medications they were taking. Anthropometric indices, along with blood pressure, were assessed. In order to measure the levels of glucose, lipid profile, and CD4+ cells in the plasma, fasting blood samples were collected.