Pöting A, Schauzu M
Bundesinstitut für Risikobewertung, Berlin.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jun;53(6):583-8. doi: 10.1007/s00103-010-1062-7.
The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.
转基因植物及其衍生食品投放市场受欧盟第1829/2003号法规监管。根据该法规，申请者需依据欧洲食品安全局（EFSA）转基因生物科学小组的指导文件进行安全评估，该指导文件基于国际公认的建议。本文概述了相关基础法规以及安全评估的策略和科学标准，安全评估通常应基于实质等同概念，并针对未改性的传统对应物进行。除了预期的基因改造外，还必须评估潜在的非预期变化对消费者的潜在不利影响。迄今为止，欧洲食品安全局评估的所有转基因植物及其衍生食品都被认为与相应传统植物衍生的产品一样安全。
