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Documents EFSA concernant les OGM

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EFSA 23/07/20 Allergenicity assessment of GM plants: stakeholders to support working group. EFSA is setting up a stakeholder consultative group to support its upcoming work on the allergenicity assessment of genetically modified (GM) plants.

EFSA 23/07/20 Allergenicity assessment of GM plants: stakeholders to support working group

The group will be consulted at various stages during the process and will provide input to the EFSA scientific working group in charge of the activity. Nominations for membership of the stakeholder group will be accepted from registered EFSA stakeholder organisations as well as non-registered bodies with an interest in the area of allergenicity assessment. More information here. EFSA 25/03/21 Administrative guidance for the preparation of applications on genetically modified plants. EFSA 20/08/18 Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation. VKM_NO 18/10/16 Comments to the EFSA draft guidance document on allergenicity assessment of GM-Plants. The Norwegian Scientific Committee for Food Safety (VKM) supports EFSA in their proposed supplementary Guidance Document on allergenicity assessment of genetically modified (GM) plants On 26th of July 2016 EFSA launched a public consultation on a draft Guidance Document on allergenicity assessment of genetically modified (GM) plants.

VKM_NO 18/10/16 Comments to the EFSA draft guidance document on allergenicity assessment of GM-Plants

Interested parties were invited to submit written comments by 25th of September 2016. EFSA 24/06/19 Administrative guidance on the submission of applications for renewal of authorisation of genetically modified food and feed under Articles 11 and 23 of Regulation (EC) No 1829/2003. EFSA 25/03/21 Administrative guidance for the preparation of renewal applications on genetically modified food and feed. EFSA 29/07/10 Outcome of the public consultation on the draft opinion on the assessment of allergenicity of GM plants and microo. EFSA 09/06/11 Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and fe. EFSA Journal 2011;9(6):2193 [54 pp.]. doi:10.2903/j.efsa.2011.2193 EFSA Panel on Genetically Modified Organisms (GMO)Panel Members Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel WalAcknowledgment The Panel wishes to thank the following members of the Updated GMM GD Working Group: Niels Bohse Hendriksen, John Heritage, Klaus-Dieter Jany, Martinus Løvik and John Threlfall for the preparatory work on this scientific opinion and EFSA staff: Jaime Aguilera and Ana Gomes for the support provided to this scientific opinion.

EFSA 09/06/11 Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and fe

Detlef Bartsch was member of the Updated GMM GD Working Group until 28 March 2011.Contact. EFSA 30/07/10 Environmental risk assessment criteria for genetically modified fishes. EFSA 29/07/10 Assessment of allergenicity of GM plants and microorganisms and derived food and feed. EFSA Journal 2010; 8(7):1700 [168 pp.]. doi:10.2903/j.efsa.2010.1700 Type: Opinion of the Scientific Committee/Scientific Panel On request from: EFSA Question number: EFSA-Q-2005-125 Adopted: 30 June 2010 Published: 29 July 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy The weight-of-evidence, case-by-case approach is considered the most appropriate way of assessing the allergenicity of genetically modified (GM) food and feed.

EFSA 29/07/10 Assessment of allergenicity of GM plants and microorganisms and derived food and feed

This scientific opinion discusses various aspects to increase the strength and accuracy of this approach, including the latest developments pertaining to clinical aspects of allergic reactions, structural aspects of GM food and feed and in silico approaches, as well as IgE binding studies and cell-based methods, profiling techniques and animal models. . © European Food Safety Authority, 2010 The background information, scientific evidence and rationale on which the conclusions and recommendations are based, can be found in the annexes.

EFSA 20/11/17 Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. EFSA JOURNAL 13/01/12 Guidance on the risk assessment of food and feed from genetically modified animals and on animal health an. EFSA Journal 2012;10(1):2501 [43 pp.]. doi:10.2903/j.efsa.2012.2501 EFSA Panel on Genetically Modified Organisms (GMO)EFSA Panel on Animal Health and Welfare (AHAW)Panel Members Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Poeting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel WalAnette Bøtner, Donald Broom, Marcus G.

EFSA JOURNAL 13/01/12 Guidance on the risk assessment of food and feed from genetically modified animals and on animal health an

Doherr, Mariano Domingo, Jörg Hartung, Linda Keeling, Frank Koenen, Simon More, David Morton, Pascal Oltenacu, Fulvio Salati, Mo Salman, Moez Sanaa, James M. Sharp, Jan A. Stegeman, Endre Szücs, Hans-H. One member of the GMO Panel did not participate in the discussion on the subject referred to above because of potential conflict of interest identified in accordance with the EFSA policy on declarations of interests.Contact. EFSA 06/07/20 Assessment of the outcomes of the project “Risk Assessment of Genetically Engineered Organisms in the EU and Switzerland” (RAGES) EFSA 13/05/20 Annual Report of preparatory activities for the evaluation of toxicity studies supporting the GM food/feed safety assessment, performed during the period 28/11/2018 to 5/12/2019. EFSA 15/05/19 Annual Report on preparatory support for the statistical evaluation of the comparative assessment of GM plant field trials and for the evaluation of toxicological studies for GM plant food/feed safety – Lot 1: Comparative statistical analysi.

EFSA 15/05/19 Annual Report on preparatory support for the statistical evaluation of the comparative assessment of GM plant field trials and for the evaluation of toxicological studies for GM plant food/feed safety – Lot 1: Comparative statistical analysi. EFSA 04/04/19 Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market.

EFSA 20/02/19 Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018. EFSA 29/01/18 Explanatory note on the selection of forage material suitable for the risk assessment of GM feed of plant origin. EFSA - AOUT 2017 - Infographie : Risk assessment of genetically modified plants. EFSA 15/01/14 Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2013.

EFSA 06/10/14 Software tool delivers GM data analysis with a single click. Under EU law, genetically modified organisms (GMOs) must undergo a risk assessment before entering the market.

EFSA 06/10/14 Software tool delivers GM data analysis with a single click.

An integral part of this scientific review is the evaluation of field trials that provide data for comparative assessment - an approach that compares GM plants with their conventional counterparts. EFSA, in collaboration with Wageningen University and Research Centre, in the Netherlands, has developed a software tool to perform the statistical analysis necessary for comparative assessment in a way that complies with EFSA guidelines and European Union legislation. Dr Claudia Paoletti, of EFSA’s GMO Unit, said: “This software is a valuable working tool for anyone wishing to produce data in line with the recommendations in EFSA guidance. Stakeholders, including applicants, who apply the GMO software tool properly can be sure the comparative data are fit for purpose for risk assessment. However, the software is a supporting tool made available by EFSA to help all stakeholders.

EFSA 04/12/14 Rapport sur l’iARN: préparer l’EFSA à la prochaine génération d’OGM. L’atelier a réuni plus de 100 scientifiques et experts en évaluation des risques issus du monde universitaire, d’organismes d’évaluation des risques, d’organisations non gouvernementales et du secteur privé.

EFSA 04/12/14 Rapport sur l’iARN: préparer l’EFSA à la prochaine génération d’OGM

Pendant deux jours, des spécialistes venus de quatre continents ont mis en commun leurs connaissances et débattu des dernières avancées scientifiques en matière d’iARN pratiquée sur des plantes, des mammifères et des invertébrés, exploré les applications actuelles et futures de la technique de l’iARN et évalué différentes réflexions sur l’évaluation des risques à la lumière du développement de cette technique. L’acide ribonucléique (ARN) agit en tant que messager de l’organisme en transportant des informations génétiques vers la partie d’une cellule qui fabrique les protéines, les éléments constitutifs essentiels de la vie.

L’iARN est un processus naturel qui bloque ce processus ou interfère avec cette activité chez les animaux et les plantes. Le Dr. EFSA 27/05/14 International workshop to explore risk assessment implications of emerging GM technique. Ribonucleic acid (RNA) acts as the body’s messenger by carrying genetic information to the part of a cell that makes proteins – key building blocks of life.

EFSA 27/05/14 International workshop to explore risk assessment implications of emerging GM technique.

RNAi is a natural process that blocks or interferes with this activity in animals and plants. In the late 1990s, scientists discovered how to use this mechanism to control the flow of genetic information. EFSA has organised this international workshop as a proactive step to assess whether the technique will affect its present risk assessment approach. EFSA 24/06/15 EFSA clarifies data requirements for GM plant risk assessment. Nouvelle 24 juin 2015 New EFSA guidance clarifies the data needs for the agronomic and phenotypic characterisation of genetically modified (GM) plants.

EFSA 24/06/15 EFSA clarifies data requirements for GM plant risk assessment

The document complements existing guidance on data requirements for the risk assessment of GM plants. It provides applicants seeking market approval for a GM plant in the European Union with recommendations on how to generate, analyse and interpret agronomic and phenotypic data of the GM plant. Comparative approach Any risk assessment of GM plants includes the comparison of the agronomic and phenotypic characteristics of the GM plant with its conventional counterpart.

Specific data requirements Based on the experience gained with previous evaluations of GM plant applications, EFSA decided to develop this guidance and make data requirements more specific. The selection of test materials and sites the quality and design of field trials the selection of specific plant characteristics to measure its biology and behaviour.

Références EFSA concernant le maïs MON810. EFSA Features: Rapport sur l’iARN: préparer l’EFSA à la prochaine génération d’OGM. Dossier 4 décembre 2014 En juin 2014, l’EFSA a organisé un atelier scientifique international pour discuter des risques potentiels associés aux plantes génétiquement modifiées (GM) issues de la technique de l’interférence de l’acide ribonucléique (iARN) et pour identifier des questions propres à leur évaluation des risques.

EFSA Features: Rapport sur l’iARN: préparer l’EFSA à la prochaine génération d’OGM

La biologie moléculaire sur laquelle repose le mécanisme de l’iARN, les applications actuelles et futures de plantes GM modifiées par la technique de l’iARN et divers aspects de l’évaluation des risques ont fait l’objet d’un examen détaillé au cours de l’atelier. Le rapport de cet événement, incluant des résumés des présentations et des discussions, est maintenant disponible sur le site web l’EFSA.

L’atelier a réuni plus de 100 scientifiques et experts en évaluation des risques issus du monde universitaire, d’organismes d’évaluation des risques, d’organisations non gouvernementales et du secteur privé. Q: Quelles sont les principaux résultats issus de cet atelier? EFSA - 2013 - Review of the strategies for the comprehensive food and feed safety and nutritional assessment of GM plants per se.

EFSA - 2013 - Review of the strategies for the comprehensive food and feed safety and nutritional assessment of GM plants per se1 – guatemalt

EFSA 19/09/12 How EFSA assesses the safety of GMOs. EFSA 31/10/11 Présentation : EU GMO Environmental Risk Assessment. EFSA 07/12/11 EFSA publishes general guidance on conducting 90-day oral toxicity study in rodents on whole food and feedEFSA has. News Story 7 December 2011 The European Food Safety Authority (EFSA) has published its first general guidance for carrying out 90-day feeding studies on whole food and feed in rodents.

It will support applicants in carrying out feeding trials related to applications for novel foods and food and feed derived from genetically modified organisms. The guidance, developed by the EFSA’s Scientific Committee, outlines a randomised block test design to maximise the power of the experiment while avoiding unnecessary use of test animals. With respect to animal welfare, the guidance recommends housing rodents as pairs in order to reduce stress in the animals. 90-day animal feeding studies are used to provide information for the risk assessment of food and feed and/or of individual substances contained therein. Should 90-day feeding studies be carried out with whole food/feed, the Scientific Committee recommends the use of a so-called randomised block design.

Notes to editors: EFSA 10/03/08 EFSA Report on animal feeding trials in GM plant evaluation published in peer-reviewed scientific journal. Nouvelle 10 mars 2008 Food and Chemical Toxicology, une revue scientifique examinée par les pairs, vient de publier un rapport que l’EFSA a constitué de sa propre initiative et qui analyse le recours aux essais d’alimentation animale dans le cadre de l’évaluation des OGM. Cette question a été moult fois débattue dans le processus d’évaluation des OGM. EFSA 30/01/08 EFSA works with Member States on best approaches to GMO risk assessment.

Nouvelle 30 janvier 2008 The European Food Safety Authority is working closely with Member States on GMO risk assessment. At a meeting organised by EFSA, more than 60 GMO experts from national regulatory risk assessment[1] bodies from across the European Union discussed best scientific approaches to evaluate the safety of GMOs at national and European level. EFSA is pro-actively working to keep at the forefront of risk assessment methodologies and approaches to GMOs and is working with Member States to draw on the best scientific minds in Europe on these issues.

Scientists from the European food safety watchdog, including a number from its GMO Panel, and the national experts nominated by the national food safety agencies met in November 2007 to examine EFSA’s risk assessment procedures and its Guidance Documents. EFSA 10/09/10 Defining Environmental Risk Assessment Criteria for Genetically Modified Insects to be placed on the EU Market.

EFSA 10/08/11 Document d’orientation actualisé sur la surveillance environnementale consécutive à la commercialisation des plant. Nouvelle 2 août 2011 L'Autorité européenne de sécurité des aliments (EFSA) a publié un document d'orientation actualisé sur la surveillance environnementale consécutive à la commercialisation (PMEM – post-market environmental monitoring) des plantes génétiquement modifiées (GM). Le document développe les orientations antérieures de l'EFSA dans ce domaine et renforce les exigences imposées aux demandeurs en matière de surveillance environnementale des plantes GM dont la commercialisation est autorisée dans l'Union européenne. Il contient également des recommandations à l'intention des gestionnaires des risques pour améliorer la collecte et la communication des données PMEM au sein de l'Union européenne. Comme pour tous les documents d'orientation de l'EFSA sur les organismes génétiquement modifiés (OGM), l'EFSA a consulté, à différents stades de l’élaboration de ce document, les États membres et un large éventail de parties intéressées.

Notes aux éditeurs: EFSA 15/11/10 L’EFSA met à jour son document d’orientation relatif à l’impact environnemental des plantes génétiquement modifiée. EFSA - tableau : GMO Applications. Dossier Organismes Génétiquement Modifiés.