Table_1_Food and Feed Safety of NS-B5ØØ27-4 Omega-3 Canola (Brassica napus): A New Source of Long-Chain Omega-3 Fatty Acids.docx

DHA canola, a genetically engineered Brassica napus (OECD Unique Identifier NS-B5ØØ27-4), has been developed as one of the first land-based production systems for omega-3 long-chain polyunsaturated fatty acids (LCPUFA), whose health benefits are well-established. Yet, the marine sources of these nutrients are under high pressures due to over-fishing and increasing demand. DHA canola is a plant-based source for these essential fatty acids that produces a high level of docosahexaenoic acid (DHA). This terrestrial system allows for sustainable, scalable and stable production of omega-3 LCPUFA that addresses not only the increasing market demand, but also the complex interplay of agriculture, aquaculture, and human nutrition. The vector used to produce the desired oil profile in DHA canola contains the expression cassettes of seven genes in the DHA biosynthesis pathway and was specifically designed to convert oleic acid to DHA in canola seed. The characterization and safety evaluation of food and feed produced from DHA canola are described and supported by a detailed nutritional analysis of the seed, meal, and oil. Aside from the intended changes of the fatty acid profile, none of the other compositional analytes showed biologically meaningful differences when compared to conventional canola varieties. In addition, the meal from DHA canola is compositionally equivalent to conventional canola meal. Further evidence of nutritional value and safety of DHA canola oil have been confirmed in fish feeding studies. Given that most human populations lack sufficient daily intakes of omega-3 LCPUFA, a dietary exposure assessment is also included. In conclusion, the results from these studies demonstrate it is safe to use products derived from DHA canola in human foods, nutraceuticals, or animal feeds.

二十二碳六烯酸油菜（DHA canola）是一种基因工程改造的甘蓝型油菜（Brassica napus，经合组织（OECD）唯一标识符NS-B5ØØ27-4），系首批用于生产ω-3长链多不饱和脂肪酸（LCPUFA）的陆地生产体系之一，此类脂肪酸的健康益处已得到广泛证实。然而，受过度捕捞与需求持续增长的影响，这类营养物质的海洋来源正承受巨大压力。DHA油菜作为此类必需脂肪酸的植物来源，可高效合成二十二碳六烯酸（DHA）。该陆地生产体系能够实现ω-3 LCPUFA的可持续、可规模化且稳定的生产，不仅可应对日益增长的市场需求，还能协调农业、水产养殖与人类营养之间的复杂交互关系。用于在DHA油菜中获得目标油脂组成的载体，包含了DHA生物合成途径中7个基因的表达盒（expression cassettes），其设计初衷是在油菜种子中将油酸转化为DHA。本数据集对DHA油菜来源的食品与饲料产品的特性表征及安全性评价进行了阐述，并辅以针对其种子、菜籽粕与油脂的详细营养分析作为支撑。除预期的脂肪酸组成改变外，与传统油菜品种相比，DHA油菜其他组成成分的检测指标均未表现出具有生物学意义的差异。此外，DHA油菜的菜籽粕在组成上与传统油菜籽粕并无二致。鱼类饲喂试验进一步证实了DHA菜籽油的营养价值与安全性。鉴于多数人群日常ω-3 LCPUFA摄入量不足，本数据集还包含了膳食暴露评估内容。综上，上述研究结果表明，将DHA油菜来源的产品应用于人类食品、营养保健食品（nutraceuticals）及动物饲料中均具有安全性。