The European Food Safety Authority (EFSA) has considered an application by Bayer CropScience GmbH for food and feed uses, import and processing (but not cultivation) of LLRICE62. The scientific assessment included molecular characterisation of the inserted DNA and expression of the target proteins, a comparative analysis of agronomic traits and composition, safety of the new proteins and whole food/feed evaluation with respect to nutritional quality, potential toxicity and allergenicity. Potential environmental impacts were assessed.

After this thorough review, the panel took the view that the molecular characterisation of the DNA insert and flanking regions of LLRICE62 raises no safety concerns, and that sufficient evidence for the stability of the insert structure was provided.

Based on the results of compositional analysis of samples from a representative range of environments and seasons, the GMO Panel concluded that both rough LLRICE62 and its processed products are compositionally equivalent to those of conventional rice except for the presence of the inserted new protein (PAT). Field trials revealed no unexpected changes in agronomic performance and phenotypic characteristics.

The PAT protein induced no adverse effects in acute and repeated dose oral toxicity studies in rodents. In addition, PAT is rapidly degraded in simulated gastric fluid and inactivated during heat treatments.

A 42-day feeding study on broilers and a 96-day study on growing-finishing pigs did not indicate differences in the nutritional value of LLRICE62 compared with the non-GM comparator. These animal studies support the compositional analysis which indicated no unintended effects.

The panel concluded that LLRICE62 is as safe as its non-GM comparator with respect to potential effects on human and animal health as well as on the environment, and is therefore unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses.

Source:

Opinion of the Scientific Panel on Genetically Modified Organisms on an application (reference EFSA-GMO-UK-2004-04) for the placing on the market of glufosinate tolerant genetically modified rice LLRICE62 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 from Bayer CropScience GmbH. European Food Safety Authority (30.10/07) (http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178665910099.htm)

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