《基于欧盟第1829/2003号条例对转基因玉米GA21进行风险评估(欧洲食品安全局转基因生物方案第005号文)》

  • 来源专题:转基因生物新品种培育
  • 编译者: Zhao
  • 发布时间:2017-11-02
  • 根据先正达农作物保护局(SA)第1829/2003号(EC)第1829/2003号条例提交申请的欧洲食品安全局转基因生物方案第005号文(EFSA-GMO-RX-005),欧洲食品安全管理局(GMO Panel)转基因生物小组被要求交付基于除草剂耐受性转基因玉米GA21提交授权更新申请数据后的科学风险评估。在本次更新申请中收到的数据包含市场后环境监测报告,文献的系统搜索和评估,更新的生物信息学分析以及由申请人或其代表执行的其他文件或研究成果。转基因生物评估小组对这些授权期间的数据:确定的新的危害,修改的风险或新的科学不确定性进行了评估,并未在原始申请的背景下进行评估。在假定转基因玉米GA21的DNA序列与之前已进行安全评估的DNA序列相同的情况下,转基因小组得出结论,更新方案EFSA-GMO-RX-005中没有证据表明该转基因玉米具有新的危害,改变的风险或科学的不确定性,将改变玉米GA21的原始风险评估结论。

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    • 来源专题:食物与营养
    • 编译者:潘淑春
    • 发布时间:2016-05-25
    • EFSA endeavours to develop networking and stronger cooperation with the Member States, and to strengthen its relationship with institutional partners (European Union and international) and stakeholders, as recommended by EFSA’s Management Board. In accordance with EFSA’s strategy for cooperating with Member States, the EFSA Scientific Network for Risk Assessment of GMOs (hereafter referred to as “the GMO Network”) was established in 2010. Since its inaugural meeting in November 2010, the GMO Network has met once per year. The overall goals of the GMO Network are to improve dialogue among members, build mutual understanding of risk assessment principles, enhance knowledge and confidence in the scientific assessments carried out in the EU, and increase the transparency of the process among Member States and EFSA. It aims to raise the level of harmonisation of the risk assessments developed in the EU. Currently 27 Member States and Norway are members of the GMO Network. Switzerland is invited to the GMO Network as observer. Each country was allowed to nominate two Member Organisations: one with competence in molecular characterisation and food-feed safety (MC/FF) and one with competence in environmental risk assessment (ERA). These Member Organisations have appointed in total over 60 selected scientific experts to attend the yearly meetings in the light of the topics on the agenda. A maximum of two experts per country are invited to each meeting. The sixth meeting of the GMO Network, held in May 2015, was attended by 42 scientific experts from 25 Member States and Norway, one observer from Switzerland, two hearing experts invited as speakers, one representative of the European Commission (Directorate General for Health and Consumers – DG SANTE), five EFSA GMO Panel members, and 14 EFSA scientific staff members from the GMO and Evidence Management (DATA) Units. At the sixth meeting of the GMO Network, the appointed experts were informed about follow-up activities to the discussions held at the fifth meeting of the GMO Network, active mandates of the EFSA GMO Panel, including GMO applications, risk assessment guideline development, requests for scientific advice, and procurement contracts. This was followed by discussions on the draft guidance on agronomic and phenotypic characterisation of GM plants and the draft guidance document for the risk assessment of the renewal of GM plant products authorized under Regulation (EC) No 1829/2003. Two breakout sessions were organised according to the expertise of the two groups of experts, to allow in-depth discussion of specific topics. The experts in the field of MC/FF discussed the use of EFSA Comprehensive European Food Consumption Database for estimating dietary exposure to GM foods. The experts in the ERA field discussed EFSA’s self-task activity to supplement its previous risk mitigation measures reducing exposure of non-target Lepidoptera to maize MON 810, Bt11 or 1507 pollen. At the following joint plenary session, the GMO Network experts discussed with the invited speakers risk assessment considerations for plants developed by new plant breeding techniques or synthetic biology, and for second generation GMOs respectively. This was followed by a discussion on the use of negative segregants in the comparative assessment of GMOs. EFSA also presented its Document Management System and shared information on upcoming scientific events. In 2015, GMO Network experts participated in two EFSA meetings relevant for the risk assessment of GMOs. The first one was the 96th GMO Panel plenary meeting, which was held in Brussels on 4-5 March 2015. During this meeting, the draft guidance document on agronomic and phenotypic characterisation of GM plants and the draft guidance for the risk assessment of the renewal of GM plant products authorised under Regulation (EC) No 1829/2003 were discussed. GMO Network members expressed their views and asked questions related to these draft documents, in their quality as observers to this meeting. The second one was the ‘Workshop on allergenicity assessment of GM plants’, held in the context of guidance development in Brussels, on 17 June 2015. The objective of this workshop was to involve stakeholders at an early stage of the guidance development and to enhance their participation in EFSA scientific work. GMO Network members actively participated to the discussions held at this workshop and provided valuable input.
  • 《根据第1829/2003号条例(EC)对转基因玉米MON 87411用于食品和饲料用途、进口和加工的评估(申请EFSA‐GMO‐NL‐2015‐124)》

    • 来源专题:转基因生物新品种培育
    • 编译者:zhangyi8606
    • 发布时间:2018-10-23
    • 通过表达苏云金芽孢杆菌cry3Bb1基因和DvSnf7双链RNA表达盒的修改版本对玉米根瘤菌(Diabrotica spp.)的抗性,以及通过表达CP4 5‐enolpyruvylshikimate‐3‐phosphate synthase (cp4 epsps)基因对含草甘膦除草剂的耐受性,玉米MON 87411被开发出来。分子特征数据和生物信息学分析没有发现需要对食品和饲料安全进行评估的问题。在玉米MON 87411与常规对照品的农艺性状和表型特征上没有统计学上的显著差异。玉米MON 87411的成分分析没有发现需要进一步评估的差异,除了未处理玉米MON 87411的籽粒中的棕榈酸水平之外。转基因专家小组没有发现有关Cry3Bb1和CP4 EPSPS蛋白的毒性和过敏性的安全顾虑,如玉米MON 87411所表达的,并且没有发现遗传修饰可能显著改变玉米MON 87411的总体过敏性的证据。玉米MON 87411衍生食品和饲料的营养影响有望与常规对照品和非转基因商业参考品系相同。转基因专家组的结论是,如本申请所述,玉米MON 87411在营养上等同于常规对照品和非转基因玉米参比品种,也一样安全,并且认为没有必要对食品/饲料进行市场后监测。在活性玉米MON 87411颗粒意外释放到环境中的情况下,玉米MON 87411不会引起环境安全问题。后市场环境监测计划和报告间隔符合玉米MON 87411的预期用途。转基因专家组的结论是,玉米MON 87411,如本申请所述,就对人和动物健康和环境的潜在影响而言,与常规对照品和已测试的非转基因玉米参比品种一样安全。