Search results for "Pharmacology and Toxicology"
showing 10 items of 58 documents
Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
2018
Abstract As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. The European Commission has mandated EFSA to develop a technical note to the applicants on, and checking of, the quality of the methodology, analysis and reporting covering complete sequencing of the insert and flanking regions, insertion site analysis of the GM event, and generational stability and integrity. This Technical Note puts together requirements and r…
Annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A.
2016
Requestor: European CommissionQuestion number: EFSA-Q-2015-00650; Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post-market environmental monitoring (PMEM) report for the 2014 growing season of maize MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monitoring data do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein over the 2014 season. However, as the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates …
Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) …
2017
Abstract This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed.
Assessment of genetically modified maize GA21 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐005)
2017
Efsa Panel On Genetically Modified Organisms (gmo) Requestor: European Commission (DG SANTE)Question number: EFSA-Q-2016-00714Correspondence; Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant genetically modified maize GA21. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and eval…
Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐007)
2018
Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor:European Commission (DG SANTE)Question number:EFSA-Q-2017-00028; Following the submission of application EFSA-GMO-RX-007 under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant and insect-resistant genetically modified maize NK603 x MON810. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic searc…
Metabolic detoxification: implications for thresholds.
2000
The fact that chemical carcinogenesis involves single, isolated, essentially irreversible molecular events as discrete steps, several of which must occur in a row to finally culminate in the development of a malignancy, rather suggests that an absolute threshold for chemical carcinogens may not exist. However, practical thresholds may exist due to saturable pathways involved in the metabolic processing, especially in the metabolic inactivation, of such compounds. An important example for such a pathway is the enzymatic hydrolysis of epoxides via epoxide hydrolases, a group of enzymes for which the catalytic mechanism has recently been established. These enzymes convert their substrates via…
Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐DE‐2011‐95) for the placing on the market of genetically modified maize …
2018
Abstract The GMO Panel was previously not in the position to complete the food/feed safety assessment of maize 5307 due to an inadequate 28‐day toxicity study necessary for an appropriate assessment of eCry3.1Ab protein. Following a mandate from the European Commission, the GMO Panel assessed a supplementary 28‐day toxicity study in mice on the eCry3.1Ab protein (1,000 mg/kg body weight (bw) per day) to complement its scientific opinion on application EFSA‐GMO‐DE‐2011‐95 for the placing on the market of the maize 5307 for food and feed uses, import and processing. The supplementary 28‐day toxicity study did not show adverse effects. Taking into account the previous assessment and the new in…
Assessment of genetically modified sugar beet H7‐1 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐006)
2017
Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor: European Commission (DG SANTE)Question number: EFSA-Q-2017-00026; Following the submission of application EFSA-GMO-RX-006 under Regulation (EC) No 1829/2003 fromKWS SAAT SE and Monsanto Company, the Panel on Genetically Modified Organisms of the EuropeanFood Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the datasubmitted in the context of the renewal of authorisation application for the herbicide-tolerantgenetically modified sugar beet H7-1. The data received in the context of this renewal applicationcontained a systematic search and evaluation of literature, updated bioinforma…
Stereochemical features of the hydrolysis of 9,10-epoxystearic acid catalysed by plant and mammalian epoxide hydrolases
2002
cis-9,10-Epoxystearic acid was used as a tool to probe the active sites of epoxide hydrolases (EHs) of mammalian and plant origin. We have compared the stereochemical features of the hydrolysis of this substrate catalysed by soluble and membrane-bound rat liver EHs, by soluble EH (purified to apparent homogeneity) obtained from maize seedlings or celeriac roots, and by recombinant soybean EH expressed in yeast. Plant EHs were found to differ in their enantioselectivity, i.e. their ability to discriminate between the two enantiomers of 9,10-epoxystearic acid. For example, while the maize enzyme hydrated both enantiomers at the same rate, the EH from soybean exhibited very high enantioselecti…
Colorimetric quantitation of trace amounts of sodium lauryl sulfate in the presence of nucleic acids and proteins
1992
A fast and sensitive procedure for the colorimetric detection of sodium lauryl sulfate (SDS) is presented. The assay is based upon the formation of a chloroform-extractable ion pair between lauryl sulfate and methylene blue that is quantified spectrophotometrically with an estimated detection limit of 150 ng of SDS. The method is suitable for the monitoring of contaminating traces of SDS in protein or nucleic acid samples that have the potential to interfere with enzymatic manipulations such as proteolytic digest, restriction analysis, or reverse transcription. Since the procedure is extremely simple and no special equipment is required it is accessible to every researcher concerned with SD…