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Relationships Involving Placental Lipid Activated/Transport-Related Factors and Macrosomia in Healthful Being pregnant.
The wide current geographic range of L. bryoniae, both in open fields and greenhouses, suggests that it is able to establish in most areas in the EU, including the protected zones, where its hosts are present and where impact would be possible both in open fields as well as greenhouses. All criteria for consideration as a potential protected zone quarantine pest are met. Besides, being L. bryoniae widely distributed in the EU and being plants for planting the primary pathway it could also qualify as regulated non-quarantine pest (RNQP).The EFSA Panel on Plant Health performed a pest categorisation of Liriomyza sativae (Diptera Agromyzidae) for the EU. L. #link# sativae (the cabbage or vegetable leaf miner; EPPO code LIRISA) is a polyphagous pest native to the Americas which has spread to Africa, Asia and Oceania. L. sativae can have multiple overlapping generations per year. Eggs are inserted in the leaves of host plants. Three larval instars, which feed internally on field vegetables (leaves and stems), follow. Then, ML141 into the soil where a fourth larval instar occurs immediately before pupation, which takes place in the soil. L. sativae is regulated in the EU by Commission Implementing Regulation (EU) 2019/2072 (Annex IIA). Within this Regulation, import of soil or growing medium as such or attached to plants for planting from third countries other than Switzerland is regulated. Therefore, entry of L. sativae pupae is prevented. However, immature stages on plants for planting (excluding seeds) and fresh leafy hosts for consumption, cut branches, flowers and fruit with foliage provide potential pathways for entry into the EU. L. sativae has been repeatedly intercepted in the EU, especially in basil (Ocimum spp.). Climatic conditions and the wide availability of host plants provide conditions to support establishment in the EU, both in open fields and greenhouses. Impacts on field vegetables and ornamentals as well as hosts in greenhouses would be possible. Phytosanitary measures are available to reduce the likelihood of entry. L. sativae satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. Although human-assisted movement of vegetables is considered the main spread way for L. sativae, this agromyzid does not meet the criterion of occurring in the EU for it to be regarded as a potential Union regulated non-quarantine pest.The EFSA Panel on Plant Health performed a pest categorisation of Nemorimyza maculosa (Malloch) (Diptera Agromyzidae) for the European Union (EU). N. maculosa is an oligophagous pest; cultivated hosts include Chrysanthemum, lettuce and other Asteraceae although there is little evidence of recent impacts. N. maculosa occurs widely in the Americas and is present on the island of Madeira (Portugal), where it is under official control. N. maculosa is not known to occur in mainland Portugal based on surveys. N. maculosa can have multiple overlapping generations per year. Eggs are inserted into the leaves of host plants. Developing larvae feed within leaves causing blotch mines. Pupation takes place in the soil or under debris on the ground. Immature stages on leafy host plant material such as Chrysanthemum cut flowers provide potential pathways for entry into the EU. Human-assisted movement of cut flowers, fresh leafy hosts for consumption and plants for planting with foliage are considered the main pathways for entry. Climatic conditions and the wide availability of cultivated and wild host plants provide conditions to support establishment in the EU in the open and in greenhouse. The extent of potential impacts on hosts such as ornamental Asteraceae and lettuce in the EU is uncertain. N. maculosa is regulated in the EU by Commission Implementing Regulation 2019/2072 (Annex IIA) where it appears using a synonym, Amauromyza maculosa. Within the Regulation, the import of soil or growing medium, from third countries other than Switzerland is regulated and therefore prevents the entry of N. maculosa pupae. All criteria assessed by EFSA above for consideration either as a potential union quarantine pest or as a potential regulated non-quarantine pest were met.The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of stearyl tartrate (E 483) as a food additive. The previously evaluated toxicological studies were not available, in addition to no genotoxicity data being available. Thus, adequate toxicity data on stearyl tartrate were not available for its re-evaluation. In addition, adequate data demonstrating the complete hydrolysis of stearyl tartrate (E 483) in the gastrointestinal tract and/or presystemically, that could allow read-across from data on its constituents, were lacking. Therefore, the safety of the use of stearyl tartrate as a food additive could not be assessed and the acceptable intake established by the Scientific Committee on Food (SCF) in 1978 could not be confirmed. Exposure to stearyl tartrate (E 483) was calculated using the maximum level exposure assessment scenario as neither use levels nor analytical data were available. Mean exposure to stearyl tartrate (E 483) as a food additive ranged from 0.1 mg/kg body weight (bw) per day in infants to 82.5 mg/kg bw per day in toddlers. The 95th percentile of exposure ranged from 0 mg/kg bw per day in adults to 192.7 mg/kg bw per day in toddlers. The Panel also noted that information from the Mintel's GNPD indicates that only two products have been labelled with stearyl tartrate (E 483) since 1996. Some recommendations were proposed by the Panel.The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acids, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f) as food additives. All substances had been previously evaluated by the Scientific Committee for Food (SCF) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Hydrolysis of E472a,b,c,e was demonstrated in various experimental systems, although the available data on absorption, distribution, metabolism, excretion (ADME) were limited. The Panel assumed that E472a-f are extensively hydrolysed in the GI tract and/or (pre-)systemically after absorption into their individual hydrolysis products which are all normal dietary constituents and are metabolised or excreted intact. No adverse effects relevant for humans have been identified from the toxicological database available for E472a-f. link2 The Panel considered that there is no need for a numerical acceptable daily intake (ADI) for E 472a,b,c. The Panel also considered that only l(+)-tartaric acid has to be used in the manufacturing process of E472d,e,f. The Panel established ADIs for E 472d,e,f based on the group ADI of 240 mg/kg body weight (bw) per day, expressed as tartaric acid, for l(+)-tartaric acid-tartrates (E334-337, 354) and considering the total amount of l(+)-tartaric acid in each food additive. Exposure estimates were calculated for all food additives individually, except for E 472e and f, using maximum level, refined exposure and food supplements consumers only scenarios. Considering the exposure estimates, there is no safety concern at their reported uses and use levels. In addition, exposure to tartaric acid released from the use of E 472d,e,f was calculated. The Panel also proposed a number of recommendations.The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of metatartaric acid (E 353) when used as a food additive. Metatartaric acid (E 353) had been previously evaluated by the Scientific Committee on Food (SCF) and Joint FAO/WHO Expert Committee on Food Additives (JECFA). Based on the presumption that metatartaric acid is fully hydrolysed pre-systemically to l(+)-tartaric acid, the Panel concluded that metatartaric acid (E 353) should be included in the group acceptable daily intake (ADI) of 240 mg/kg body weight (bw) per day, expressed as tartaric acid, for l(+)-tartaric acid-tartrates (E 334-337, 354) which was established by the EFSA FAF Panel in 2020. Exposure estimates were calculated for metatartaric acid (E 353) using a maximum level and refined exposure assessment scenario. The Panel also concluded that there is no safety concern for the use of metatartaric acid (E 353) at the reported use and use level. The Panel made a number of recommendations.The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on tartaric acid-tartrates (E 334-337, 354) when used as food additives. The Scientific Committee for Food (SCF) in 1990 established an acceptable daily intake (ADI) of 30 mg/kg body weight (bw) per day, for l(+)-tartaric acid and its potassium and sodium salts. The metabolism of l(+)-tartaric acid and its potassium sodium salt was shown to be species dependent, with a greater absorption in rats than in humans. No toxic effects, including nephrotoxicity, were observed in toxicological studies in which the l(+)-form was tested. There was no indication for a genotoxic potential of tartaric acid and its sodium and potassium salts. In a chronic study in rats, no indication for carcinogenicity of monosodium l(+)-tartrate was reported at the highest dose tested (3,100 mg/kg bw per day). The available studies for maternal or developmental toxicity did not report any relevant effects; no studies for reproductive toxicity were available; however, no effects on reproductive organs were observed in the chronic toxicity study. link3 The Panel concluded that the data on systemic availability were robust enough to derive a chemical-specific uncertainty factor instead of the usual default uncertainty factor of 100. A total uncertainty factor of 10 was derived by applying a total interspecies uncertainty factor of 1 instead of 10, based on data showing lower internal exposure in humans compared to rats. The Panel established a group ADI for l(+)-tartaric acid-tartrates (E 334-337 and E 354) of 240 mg/kg bw per day, expressed as tartaric acid, by applying the total uncertainty factor of 10 to the reference point of 3,100 mg sodium tartrate/kg bw per day, approximately to 2,440 mg tartaric acid/kg bw per day. The exposure estimates for the different population groups for the refined non-brand-loyal exposure scenario did not exceed the group ADI of 240 mg/kg bw per day, expressed as tartaric acid. Some recommendations were made by the Panel.The EFSA Panel on Food Additives and Flavourings was requested to evaluate 31 flavouring substances assigned to the Flavouring Group Evaluation 72 (FGE.72), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-three substances have already been considered in FGE.72 and FGE.72Rev1 ([FL-no 02.011, 02.012, 02.027, 02.029, 02.058, 02.076, 02.109, 05.020, 05.021, 05.124, 05.148, 05.169, 08.036, 08.044, 08.047, 08.055, 08.064, 08.070, 08.079, 09.273, 09.408, 09.931 and 16.001]). The remaining eight flavouring substances have been cleared with respect to genotoxicity in FGE.200Rev1 ([FL-no 05.114]) and FGE.201Rev2 ([FL-no 02.174, 05.033, 05.090, 05.095, 05.105, 05.107 and 05.126]) and they are considered in this revision 2 of FGE.72. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 31 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach.
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