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30 results for “EFSA”
EFSA Project on the use of NAMs to explore the immunotoxicity of PFAS (Annexes B, C, D1, E, G, I, K, M, O)
<p>In vitro raw data, RIN values and RNA concentrations, DNA quality assessment, RNAseq outputs and analysis of EFSA Project on the use of NAMs to explore the immunotoxicity of PFAS (OC/EFSA/SCER/2021/13). </p>
Risk assessment on Glycoalkaloids in feed and food: Occurrence data in food and feed submitted to EFSA and dietary exposure assessment for humans
<p><strong>UPDATE to version 2 of this upload:</strong></p> <p>Also the raw (no data cleaning applied to it) occurrence dataset as extracted from EFSA DWH is provided <em>in csv format</em>. This dataset is compliant with EFSA SSD model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: action) to address the issue (e.g. delete record or update values in specific fields).</p> <p><strong>Description - Version 1</strong></p> <p><strong>Annex: Tables on GAs on occurrence data in food and feed, and dietary exposure assessment for humans</strong></p> <p>Table A.1. Dietary surveys used for the estimation of acute dietary exposure to GA</p> <p>Table A.2. Number of results and samples per food category submitted to EFSA through the continuous call for data</p> <p>Table A.3. Analytical results excluded from the final dataset used to estimate dietary exposure and the criteria applied for exclusion</p> <p>Table A.4. Occurrence of alpha-chaconine and alpha-solanine (UB mg/kg) in the samples included in the final dataset (left censored results highlighted in yellow)</p> <p>Table A.5. European Starch Association data on feed and potatoes for starch</p> <p>Table A.6. Details acute assessment across surveys (consumption days only)</p> <p>Table A.7. Comparison of exposure summary results obtained using the uniform vs the normal distribution for reduction factors</p>
EFSA Project on the use of NAMs to explore interspecies metabolic differences on essential oils as feed additives (Annexes A, B, C, D)
<p>Raw data of phase I and II experiments and PBK model input data and simulation of the EFSA Project on the use of NAMs to explore interspecies metabolic differences on essential oils as feed additives (OC/EFSA/SCER/2021/14).</p>
OpenFoodTox: EFSA's chemical hazards database
<p><strong>Background: EFSA's remit and chemical risk assessment of regulated products and contaminants</strong></p> <p>The European Food Safety Authority (EFSA) has the remit to provide scientific advice to risk managers and decision makers through risk assessment and risk communication on issues related to “food and feed safety, animal health and welfare, plant health, nutrition, and environmental issues”. Risk assessment has been defined as "a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation" (EC, 2002). </p> <p>In the food and feed safety area, hazard identification and hazard characterisation aim to determine safe levels of exposure for regulated products or contaminants as “reference values<sup>1</sup>” to protect human health, animal health, environmental-relevant species or the whole ecosystem. Such reference values for a given species are most often derived by using a “reference point<sup>2</sup>" determined from the critical toxicological study on which an uncertainty factor<sup>3</sup> is applied.</p> <p>Since its creation in 2002, the European Food safety Authority (EFSA) has produced risk assessments for <strong>more than 5,700 unique substances</strong> in <strong>over 2,400 Scientific Opinions</strong><strong>, Statements and Conclusions</strong> through the work of its <a href="http://www.efsa.europa.eu/en/science/scientific-committee-and-panels">scientific Panels</a>, Units and Scientific Committee. </p> <p> </p> <p><strong>EFSA's Chemical Hazards Database: OpenFoodTox</strong></p> <p>OpenFoodTox is a structured database summarising the outcomes of hazard identification and characterisation for the human health (all regulated products and contaminants), the animal health (feed additives, pesticides and contaminants) and the environment (feed additives and pesticides). It provides open-source data for the substance characterisation, the links to EFSA’s related outputs, background European legislation, and a summary of the critical toxicological endpoints and reference value.</p> <p>The data model of OpenFoodTox has been designed using <a href="https://www.oecd.org/ehs/templates/">OECD Harmonised Templates (OHTs)</a> as a basis to collect and structure the data in a harmonised manner. OpenFoodTox provides open source data for the substance characterisation, EFSA outputs, reference points, reference values and genotoxicity.</p> <p>OpenFoodTox contributes actively to EFSA’s 2020 Science Strategy (EFSA, 2016) and to the aim of widening EFSA’s evidence base and optimising access to its data as a valuable open source toxicological database that can be shared with all scientific advisory bodies and stakeholders with an interest in chemical risk assessment. In addition, OpenFoodTox 2.0 has been submitted to the OECD’s Global Portal to Information on Chemical Substances (<a href="https://www.echemportal.org/">eChemPortal</a>) so that individual substances can be searched as part of the national and international databases. Further description and associated references are described in the EFSA journal editorial (Dorne et al., 2017) and other publications (Dorne et al., 2020).</p> <p> </p> <p><strong>What's new? OpenFoodTox 2.0 </strong></p> <p>The 2023 upgrade to OpenFoodTox 2.0 now contains <strong>physico-chemical properties</strong> and <strong>pharmacokinetic/toxicokinetic</strong> data for more than 850 substances.</p> <p>In order to disseminate OpenFoodTox 2.0 to a wider community, two sets of data can be downloaded:</p> <p><strong>1. </strong>Six individual spreadsheets including a) substance characterisation , b) EFSA outputs, c) reference points, d) reference values, e) genotoxicity and f) phys-chem&toxicokinetics data*.</p> <p><strong>2. </strong>The full database*.</p> <p> </p> <p><strong>OpenFoodTox 2.0 and innovative <em>in silico</em> models</strong></p> <p><em>In silico</em> models using OpenFoodTox 2.0 data have been developed for ecological risk assessment (bees and rainbow trout) and human risk assessment using rat toxicological data (Carnesecchi et al., 2020a; Carnesecchi et al., 2020b; Como et al., 2017; Benefenati et al., 2017; Toporov et al., 2017, Toporov et al., 2018). These <em>in silico </em>models provide alternative means to animal experiments for the hazard identification and characterisation of chemicals, and are becoming of increasing interest in the risk assessment community to deliver the 3Rs (replacement, reduction, refinement) (Hartung, 2004; OECD, 2005), particularly since the banning of animal testing for the approval of cosmetics as consumer products (Regulation (EC) No. 1223/2009, Art.18(2)).</p> <p> </p> <p> </p> <p> </p> <p><strong>Definitions</strong></p> <p><sup>1 </sup>Reference Value: the estimated maximum dose (on a body mass basis) or the concentration of an agent to which an individual may be exposed over a specified period without appreciable risk. Reference values are established by applying an uncertainty factor to the reference point. Examples of reference values in human health include acceptable daily intake (ADI) for food and feed additives, and pesticides, tolerable upper intake levels (UL) for vitamins and minerals, and tolerable daily intake (TDI) for contaminants and food contact materials. For acute effects and operators, the acute reference dose (ARfD) and the acceptable operator exposure level (AOEL). In animal health and the ecological area, these include safe feed concentrations and the Predicted no effect concentration (PNEC) respectively (EFSA Scientific Committee, 2018).</p> <p><sup>2 </sup>Reference Point: defined point on an experimental dose–response relationship for the critical effect. This term is synonymous to Point of departure (USA). Reference points include the lowest or no observed adverse effect level (LOAEL/NOAEL) or benchmark dose lower confidence limit (BDML), used to derive a reference value or Margin of Exposure in human and animal health risk assessment. In the ecological area, these include lethal dose (LD50), effect concentration (EC5/ECx), no (adverse) effect concentration/dose (NOEC/NOAEC/NOAED), no (adverse) effect level (NEL/NOAEL), hazard concentration (HC5/HCx) derived from a Species Sensitivity Distributions (SSD) for the ecosystem (EFSA Scientific Committee,2018).</p> <p><sup>3 </sup>Uncertainty factor: reductive factor by which an observed or estimated no observed adverse effect level or other reference point, such as the benchmark dose or benchmark dose lower confidence limit, is divided to arrive at a reference dose or standard that is considered safe or without appreciable risk (WHO, 2009).</p> <p>*Phys-chem and toxicokinetics data can be merged with the full database using SUB_COM_ID and OP_ID keys as available in "PhysChem_Toxicokinetics_KJ_2023" and "OpenFoodToxTX22809_2023".</p> <p> </p> <p><strong>This version replaces version 5 to include EFSA Opinions, Statements and Conclusions up to Sept 2022</strong></p>
Annexes A and B to EFSA Scientific report "Chronic dietary exposure to inorganic arsenic"
<p><strong>Annex A-</strong> Contains the raw occurrence dataset on arsenic as extracted from the EFSA DWH on 30 April 2020 (no data cleaning applied), with the food samples presented in the scientific report as described in its section 2.1. Occurrence data. The data are provided in csv format. This dataset is compliant with EFSA SSD model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: action) to address the issue (e.g. deleted record or updated values in specific fields). The link to the catalogues of controlled terminologies can be found under "Related identifiers”. </p> <p><strong>Annex B-</strong> Contains summary statistics on occurrence data, consumption data, and dietary exposure assessment results.</p> <p>Table B1. Dietary surveys per country and age group available in the EFSA Comprehensive Database considered in the chronic dietary exposure assessment to inorganic arsenic.</p> <p>Table B2. Analytical data on iAs after data cleaning and analysis steps (13,608 analytical results).<br> Table B3. Occurrence values of inorganic arsenic in food (µg/kg) as used for the exposure assessment.<br> Table B4. Occurrence values of total arsenic in food (µg/kg).<br> Table B5. Summary of the chronic dietary exposure assessment to inorganic arsenic (µg/kg bw per day).<br> Table B6. Detailed chronic dietary exposure assessment to inorganic arsenic (µg/kg bw per day) by European dietary surveys and age classes.</p> <p>Table B7. Main contributing food groups (%) to the mean LB and UB chronic dietary exposure to inorganic arsenic across European dietary surveys and age classes.</p> <p>Table B8. Detailed mean contribution of food groups (%) to the mean LB and UB chronic dietary exposure to inorganic arsenic across European dietary surveys and age classes. </p>
Top topics from word2vec run of EFSA outputs
<p>List of neural word embeddings extracted from EFSAs outputs and their closest neighbours, which have a distance < 0.3 to the original word.</p> <p>These group of words form a congruent groups which for a human seems to represent a topic.</p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p>
Microbiological agents as notified to EFSA
<p>This is the list of “Microbiological agents as notified to EFSA” from 2007, in the context of technical dossiers to EFSA Units, for intentional use in feed and/or food or as sources of food and feed additives, enzymes and plant protection products (PPPs) for safety assessment.</p> <p>This is supplementing the QPS statements part 11, part 12, part 13, part 14, part 15, part 16, part 17, part 18, part 19, part 20, part 21, part 22 and the 2022 Scientific Opinion of the BIOHAZ Panel of EFSA - see related identifiers.</p> <p>EFSA topic on QPS: <a href="https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.efsa.europa.eu%2Fen%2Ftopics%2Ftopic%2Fqualified-presumption-safety-qps&data=02%7C01%7C%7Ca3e4d3a851c84defc2a008d7aa44f9e5%7C406a174be31548bdaa0acdaddc44250b%7C1%7C0%7C637165085527366985&sdata=TlcglouTWhBY24K5ApAoawNpADKgyl%2FefxVUEbxjQo0%3D&reserved=0">https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps</a></p>
Updated list of QPS-recommended microorganisms for safety risk assessments carried out by EFSA
<p>The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a scientific Opinion on the maintenance of the list of qualified presumption of safety (QPS) biological agents. The QPS approach was developed by the EFSA Scientific Committee to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents intentionally introduced into the food and feed chain, in support of the concerned scientific Panels and Units in the frame of market authorisations.</p> <p>The taxonomic identity, body of knowledge, the safety concerns in relation to pathogenicity and virulence, and the safety for the environment of those microbiological agents are assessed. Safety concerns identified for a respective taxonomic unit (TU) are, where possible and reasonable in number, reflected as ‘qualifications’ that are assessed at the strain level by the EFSA’s scientific Panels.</p> <p>The<strong> “list of microorganisms with QPS status”</strong> first established in 2007, has been revised and updated annually until 2014 via <strong>QPS</strong> <strong>Opinions</strong>; since 2014 the updates are carried out and published every 3 years. If new information is retrieved from extended literature searches (ELS) that would change the QPS status of a TU or its qualifications, this is also published in the Panel Statement covering the previous 6-months period. The <strong>ELS </strong><strong>protocol</strong> can be found at <a href="https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fzenodo.org%2Fdoi%2F10.5281%2Fzenodo.3607188&data=05%7C02%7C%7Ca719c81b95134433fddc08dc112814e1%7C406a174be31548bdaa0acdaddc44250b%7C1%7C0%7C638404111040390688%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=FaY3tbLnn%2BB%2BDu3PrtEzJR0zPa14z%2FpoKWUBBOaHk34%3D&reserved=0">https://zenodo.org/doi/10.5281/zenodo.3607188</a> and the <strong>Search</strong><strong> strategies</strong> are available at: <a href="https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdoi.org%2F10.5281%2Fzenodo.3607193&data=02%7C01%7C%7Ca3e4d3a851c84defc2a008d7aa44f9e5%7C406a174be31548bdaa0acdaddc44250b%7C1%7C0%7C637165085527347066&sdata=tCzKMQLR2I%2BZBr%2F0sOXPDoPitdjQyqKdlVqDqwigA%2Bo%3D&reserved=0">https://doi.org/</a><a href="https://doi.org/10.5281/zenodo.3607192">10.5281/zenodo.3607192</a>.</p> <p> </p> <p>The <strong>QPS Panel Statement</strong> also includes the evaluation of microbiological agents notified to EFSA within the 6-month period for an assessment for feed additives, food enzymes, food additives and flavourings, and novel foods or plant protection products for a possible QPS status. The new QPS status recommendations are incorporated into the 2022 updated<strong> “list of microorganisms with QPS status</strong>” is available in this upload. The list of “<strong>Microbi</strong><strong>ological agents </strong><strong>as notified to EFSA</strong><strong>”</strong> from 2007, in the context of technical dossiers to EFSA Units, for intentional use in feed and/or food or as sources of food and feed additives, enzymes and plant protection products (PPPs) for safety assessment can be found at <a href="https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdoi.org%2F10.5281%2Fzenodo.3607184&data=02%7C01%7C%7Ca3e4d3a851c84defc2a008d7aa44f9e5%7C406a174be31548bdaa0acdaddc44250b%7C1%7C0%7C637165085527357024&sdata=%2Fe7qiRXiuKQi%2FBvK5S%2F7undYHv7ibxBlLEHPcSlRz24%3D&reserved=0">https://doi.org/10.5281/zenodo.</a><a href="https://doi.org/10.5281/zenodo.3607183">3607183</a>.</p> <p> </p> <p><strong>Useful links on EFSA QPS</strong></p> <p>EFSA topic on QPS: <a href="https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.efsa.europa.eu%2Fen%2Ftopics%2Ftopic%2Fqualified-presumption-safety-qps&data=02%7C01%7C%7Ca3e4d3a851c84defc2a008d7aa44f9e5%7C406a174be31548bdaa0acdaddc44250b%7C1%7C0%7C637165085527366985&sdata=TlcglouTWhBY24K5ApAoawNpADKgyl%2FefxVUEbxjQo0%3D&reserved=0">https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps</a></p> <p>Link to the virtual issue on QPS on Wiley Online Library: <a href="https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fefsa.onlinelibrary.wiley.com%2Fdoi%2Ftoc%2F10.1002%2F(ISSN)1831-4732.QPS&data=02%7C01%7C%7C7f88eba744034d83233b08d7a8cd3c1c%7C406a174be31548bdaa0acdaddc44250b%7C1%7C0%7C637163471731831002&sdata=AiprIUek%2B%2But46VabBGk0IMIgLR98CDmxoINYPkKBbs%3D&reserved=0">https://efsa.onlinelibrary.wiley.com/doi/toc/10.1002/(ISSN)1831-4732.QPS</a></p> <p><strong>Versions history:</strong></p> <p>Versions 1 and 2 were substituted by version 3 – all are associated with the QPS Panel statement EFSA 7: suitability of taxonomic units notified to EFSA until September 2017: <a href="https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5131">https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5131</a> </p> <p>Version 4 is associated with the QPS Panel statement EFSA 8: suitability of taxonomic units notified to EFSA until March 2018: <a href="https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5315">https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5315</a> </p> <p>Versions 5 and 6 were substituted by version 7 – all are associated with the QPS Panel statement EFSA 9: suitability of taxonomic units notified to EFSA until September 2018: <a href="https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5555">https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5555</a> </p> <p>Version 8 is associated with the QPS Panel statement EFSA 10: suitability of taxonomic units notified to EFSA until March 2019: <a href="https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5753">https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5753</a> </p> <p>Version 9 is associated with the QPS Panel statement EFSA 11: suitability of taxonomic units notified to EFSA until September 2019: <a href="https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5965">https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5965</a> and with the Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA (2017-2019): <a href="https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5966">https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5966</a> </p> <p>Version 10: updates version 9 following the update of the qualification of <em>Bacillus velezensis</em> as: ‘absence of toxigenic potential and absence of aminoglycoside production ability’ - applied in the QPS Statement part 11 (ON-5965) and in the 2019 Scientific Opinion (ON-5966).</p> <p>Version 11: updates version 10 following the addition of the <em>Bacillus circulans</em> ‘for production purposes only’ - applied in the QPS Statement part 13 (ON-6377) and in the 2019 Scientific Opinion (ON-5966).</p> <p>Version 12 updates version 11 following the addition of the <em>Bacillus paralicheniformis</em><strong> </strong>with the qualifications 'absence of toxigenic activity’ and ‘absence of genetic information to synthesize bacitracin';<strong> </strong>and adding <em>Schizochytrium limacinum</em>, which is a synomym for <em>Aurantiochytrium</em> <em>limacinum,</em> - applied in the QPS Statement part 14 (ON-6689)<strong> </strong>and in the 2019 Scientific Opinion (ON-5966).</p> <p>Version 13 updates version 12 following the addition of <em>Haematococcus lacustris</em> synonym <em>Haematococcus pluvialis</em>, recommended for QPS status with the qualification ‘for production purposes only’. Some other changes related to taxonomy and qualifications are described in the QPS Statement part 15 (ON-7045)<strong>.</strong></p> <p>Version 14, update of version 13, is related to QPS Statement part 16 (ON-7408)<strong>.</strong></p> <p>Version 15 is related to QPS Statement part 17 (ON-7746)<strong>.</strong></p> <p>Version 16 is related to QPS Statement part 18 (ON-8092)<strong>.</strong></p> <p>Version 17 is related to QPS Statement part 19 (ON-8517)<strong>.</strong></p> <p>Version 18 is also related to QPS Statement part 19 (ON-8517) with a small correction<strong>.</strong></p> <p>Version 19 and 20 are related to QPS Statement part 20 (ON-8882).</p> <p>Version 21 is related to QPS Statement part 21 (ON-9169)</p> <p>Version 22 is related to QPS Statement part 22 (ON-9510)</p> <p> </p> <p> </p> <p><strong>Note: </strong>As of January 2022 the updated list is provided only as excel file format.</p>
Video tutorial for creating uploads on EFSA's Knowledge Junction community of Zenodo
<p>The Knowledge Junction is a curated, open repository for the exchange of evidence and supporting materials used in food and feed safety risk assessments, with the goal of improving transparency, reproducibility and evidence reuse. The content of this repository can be used by EFSA's panels and working groups and any other interested parties when preparing for new risk assessments. </p> <p>The video tutorial describes the process of creating a new upload along with filling out the metadata based on the requirements for publishing objects in Knowledge Junction. </p> <p><strong>Objects suitable for submission to the repository</strong></p> <ul> <li>Objects which already have a DOI should <strong>not</strong> be published in the repository</li> <li>Objects which are subject to copy right restrictions should <strong>not</strong> be published in the repository</li> <li>All other evidence and supporting materials of relevant for food and feed safety will be accepted if the metadata provided is completed according to the instructions below</li> </ul>
EFSA Opinion Update of risks for animal health related to the presence of ochratoxin A (OTA) in feed: Annexes on Occurrence data in feed submitted to EFSA
<p>Annexes to EFSA's Update Opinion on the risks for animal health related to the presence of OTA in feed. Annex B includes the occurrence data in feed extracted from EFSA Data Warehouse for the period from 2012 to 2021. Annex C contains the occurrence data expressed in dry matter following analysis and cleansing of the dataset as detailed in EFSA's Opinion. Annex D lists the samples of 'Compound feed' and other feed materials except forage expressed in whole weight. The number of samples across some of the feed categories differ among the two annex C and D because in few cases the moisture content was not reported (and no assumption on the moisture could be done), precluding the conversion of the analytical results to either whole weight or dry matter. </p>
EFSA cgMLST gene lists for Escherichia coli and Salmonella enterica chewieNS schema
<p>Annex A contains the list of cgMLST loci of <em>Escherichia coli</em> and <em>Salmonella enterica</em> used in the cgMLST analysis in the EFSA One Health WGS System.</p>
Occurrence data on TBBPA and its derivatives provided to EFSA
<p>The file contains the raw occurrence dataset on TBBPA and its derivatives in food as extracted from EFSA DWH on 1 of December 2022 and presented in the EFSA opinion on the update of the risk assessment of TBBPA and its derivatives in food available. This dataset is compliant with EFSA SSD2 data model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the outcome of the action taken (column: outcome) to address the issue (e.g. delete record or update values in specific fields). The link to the catalogues of controlled terminologies for the updated textual description of fields values can be found under "Related works, supplemented by”.</p>
Occurrence data on brominated phenols and their derivatives provided to EFSA
<p><span>The file contains the raw occurrence dataset on brominated phenols and their derivatives in food as extracted from EFSA DWH on 1 of December 2022 and presented in the EFSA opinion on the update of the risk assessment of brominated phenols and their derivatives in food. This dataset is compliant with EFSA SSD2 data model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the outcome of the action taken (column: outcome) to address the issue (e.g. delete record or update values in specific fields). The link to the catalogues of controlled terminologies for the updated textual description of fields values can be found under "Related works, supplemented by”.</span></p>
Annexes to the EFSA external scientific report "Proposed prospective scenarios for cumulative risk assessment of pesticide residues"
<p>In the context of prospective cumulative risk assessment of pesticides, different options and scenarios for a tiered approach were investigated by means of 15 case studies for the cumulative assessment group associated with an effect on the motor division of the nervous system (CAG-NAM) and 15 case studies for the cumulative assessment group associated with an effect on hypothyroidism (CAG-TCF) (doi:10.2903/sp.efsa.2021.EN-6811). The results of the prospective exposure calculations are reported in the following annexes:</p> <p><strong>Annex A</strong>: Acute exposure calculations - CAG-NAM</p> <p><strong>Annex B</strong>: Chronic exposure calculations - CAG-TCF</p> <p><strong>Annex C</strong>: Results supporting the discussion on prospective acute scenarios - CAG-NAM</p> <p><strong>Annex D</strong>: Results supporting the discussion on prospective chronic scenarios - CAG-TCF</p> <p>The case studies reported above also include fictitious data, which were included for assessing the relevance of the various parameters in these calculations. The results of these case studies do not represent real estimates of exposure or risk, nor do they represent the formal outcome of a risk assessment.</p>
Raw data of the EFSA NAMs Project on Tebufenpyrad, Part 2 (Annex B) (NP/EFSA/SCER/2020/02) (Alimohammadi et al., 2023)
<p>Raw data of the <em>in vitro</em> experiments produced in the context of the EFSA Pilot Project on 'New Approach Methodologies (NAMs) for Tebufenpyrad Risk Assessment. Part 2. Hazard characterisation and identification of the Reference Point’ outsourced to University of Konstanz (Annex B) (NP/EFSA/SCER/2020/02) (Alimohammadi et al., 2023).</p>
Raw data of the EFSA NAMs Project on Tebufenpyrad, Part 1 (Annex B) (GP/EFSA/SCER/2020/02) (Henri et al., 2023)
<p>Raw data of the <em>in vitro</em> experiments produced in the context of the EFSA Pilot Project on 'New Approach Methodologies (NAMs) for Tebufenpyrad Risk Assessment. Part 1. Development of Physiologically-Based Kinetic (PBK) Model Coupled With Pulmonary and Dermal Exposure’ outsourced to ANSES (Annex B) (GP/EFSA/SCER/2020/02) (Henri et al., 2023).</p>
Occurrence data on N-nitrosamines provided to EFSA
<p>The file contains the raw occurrence dataset on nitrosamines in food as extracted from EFSA DWH on 3 July 2021 and presented in the EFSA opinion on Risk assessment of N-nitrosamines in food available at https://doi.org/10.2903/j.efsa.2023.7884. The data is provided in csv format. This dataset is compliant with EFSA SSD2 data model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: action) to address the issue (e.g. delete record or update values in specific fields).</p> <p>The link to the catalogues of controlled terminologies for the updated textual description of fields values can be found under "Related identifiers”.</p>
EFSA's Public MetaPath database
<p>This MTB file contains a collection of maps publicly available that can be used with the MetaPath platform to search and analyse experimental data on metabolism or catabolism. The External Scientific Report by EFSA's contractor, the German Federal Institute for Risk Assessment (BfR), describes how the extraction and coding of the data on which this database was based was conducted. </p> <p>For more details and background information please consult <a href="https://www.efsa.europa.eu/en/applications/pesticides/tools">EFSA website</a></p> <p> </p> <p><strong>Intellectual Property Rights Notice</strong></p> <p>The reproduction, distribution, redistribution, exploiting, making commercial or further use of information, documents and data posted or otherwise made available on this website or in the websites linked to it may be subject to protection under intellectual property rights regulations, data exclusivity clauses or other applicable law, and their utilisation without obtaining the prior permission from the right(s)holder(s) of the respective information, documents and data might violate the pre-existing rights of the respective right(s)holder(s).</p> <p>For materials subject to intellectual property rights or other rights of a third party, the User must comply with the terms of use associated with such material or obtain the necessary and written permission for reproduction, distribution or any other use from the right(s)holder(s).</p> <p>EFSA does not accept any responsibility, and shall not be held liable, for any violation of any pre-existing rights or other infringements related to information, documents and data made available on this website or in the websites linked to it.</p>
Copper occurrence data related to EFSA opinion on copper 2023
<p>The file contains the raw occurrence dataset on copper in food as extracted from EFSA DWH on 10th of March 2021 and presented in the EFSA opinion on "Re‐evaluation of the existing health‐based guidance values for copper and exposure assessment from all sources" available at https://doi.org/10.2903/j.efsa.2023.7728. The data is provided in csv format. This dataset is compliant with EFSA SSD2 data model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: action) to address the issue (e.g. delete record or update values in specific fields).</p> <p>The link to the catalogues of controlled terminologies for the updated textual description of fields values can be found under "Related identifiers”.</p>
Annexes to the EFSA external scientific report on the standard regulatory action for retrospective cumulative risk assessment of pesticides in MCRA
<p>Annexes to the EFSA external scientific report on the standard regulatory action for retrospective cumulative risk assessment of pesticides in MCRA.</p> <p>Harmonized methodology for retrospective dietary cumulative risk assessment (CRA) of pesticides was established by the European Commission (EC) and the European Food Safety Authority (EFSA) in 2018, in close collaboration with the Dutch National Institute for Public Health and the Environment (RIVM). An update of this regulatory methodology (RM) was proposed and adopted by EFSA in 2022 in a CRA on craniofacial alterations. This updated RM was implemented in version 10 of the MCRA software and validated as part of the first action defined in the third framework partnership agreements between EFSA and RIVM. This report describes the implementation of this updated methodology in the MCRA software for risk assessment. This is done from a proposed framework of standard regulatory actions (SRAs). SRAs offer a user-friendly and simple to use option for regulators to perform retrospective and prospective CRAs in MCRA according to agreed-upon RMs. In particular, this report provides guidance on the use of an SRA for a retrospective dietary CRA for craniofacial alterations according to the updated RM in MCRA version 10.</p> <p>Detailed results of the comparison between reported by MCRA and EFSA’s SAS® software and MCRA formatted input files for the catalogues and secondary data are presented in the following annexes:</p> <ul> <li>Annex A – Comparison of the MOET at different percentiles reported by MCRA and EFSA’s SAS® software for retrospective dietary CRA of craniofacial alterations. </li> <li> <p>Annex B – Comparison of risk-driver contributions reported by MCRA and EFSA’s SAS® software for retrospective dietary CRA of craniofacial alterations. </p> </li> </ul> <ul> <li> <p>Annex C – MCRA formatted input data file containing the primary entity catalogues for the SRA on retrospective dietary CRA of craniofacial alterations. </p> </li> <li> <p>Annex D – MCRA formatted input data file containing the secondary data for the SRA on retrospective dietary CRA of craniofacial alterations. </p> </li> <li> <p>Annex E – MCRA formatted input data file containing the unit- variability factors for the Tier II calculations of the SRA on retrospective dietary CRA of craniofacial alterations. </p> </li> <li> <p>Annex F – MCRA formatted input data file containing the unit- variability factors for the Tier I calculations of the SRA on retrospective dietary CRA of craniofacial alterations. </p> </li> </ul> <p> </p>
ScienceDex guides
Understand access before you commit
These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.