Opinion of the GMO Panel related on an application (Reference EFSA-GMO-NL-2005-13) for the placing on the market of glufosinate-tolerant genetically modified LLCotton25, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience

Summary

This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified LLCotton25 (Unique Identifier ACS-GHØØ1-3) developed to provide tolerance to glufosinate-containing herbicides.

In delivering its opinion the GMO Panel considered the application EFSA-GMO-NL-2005-13, additional information provided by the applicant (Bayer CropScience) and the scientific comments submitted by the Member States. The application EFSA-GMO-NL-2005-13 covers the import and processing of LLCotton25 seeds and its derived products for use as food (e.g. oil, linters) and/or feed (e.g. meal, hulls, oil). The GMO Panel assessed LLCotton25 with reference to the intended uses and the appropriate principles described in the Guidance document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed. The scientific assessment included molecular characterization of the inserted DNA and expression of the target protein. A comparative analysis of agronomic traits and composition was undertaken and the safety of the new protein and the whole food/feed was evaluated with respect to potential toxicity and allergenicity. Both, a nutritional and an environmental assessment, including a monitoring plan, were undertaken.

LLCotton25 is derived from the cotton variety Coker312 which was transformed by Agrobacterium-mediated gene transfer technology. LLCotton25 expresses the bar gene leading to the production of the enzyme, phosphinothricin acetyl-transferase (PAT) that acetylates L-glufosinate-ammonium. The PAT enzyme confers tolerance to glufosinate-containing herbicides (trade names: Liberty®, Basta®).

Molecular analysis shows that LLCotton25 contains a single insert and does not retain backbone sequences from the vector. The GMO Panel is of the opinion that bioinformatic analysis of the DNA insert and flanking regions indicates no cause for concern, and that sufficient evidence for the stability of the insert structure was provided.

Compositional and agronomic analyses indicate that the LLCotton25 was compositionally and agronomically equivalent to other tested conventional cotton lines, except for the introduced transgenic trait. The comparative analysis of LLCotton25 therefore provides no indication for unintended effects resulting from the genetic modification. The GMO Panel is therefore of the opinion that the LLCotton25 is as safe as its non genetically modified counterparts.

The application EFSA-GMO-NL-2005-13 concerns import, processing and food/feed uses. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of LLCotton25. The GMO Panel agrees that unintended environmental effects due to the establishment and spread of LLCotton25 will not be different from that of conventionally bred cotton.

Considering the intended uses of LLCotton25, the monitoring plan provided by the applicant is in line with the EFSA Guidance document and the opinion of the GMO Panel on post-market environmental monitoring. However the GMO Panel is aware that, due to the physical characteristics of cotton seeds and methods of transportation, accidental spillage is unavoidable. Therefore the GMO Panel recommends that specific measures are introduced to actively monitor the occurrence of feral cotton plants in areas where seed spillage is likely to occur.

In conclusion, the GMO Panel considers that the information available for LLCotton25 addresses the scientific comments raised by the Member States and that the genetically modified LLCotton25 is as safe as its non genetically modified counterparts with respect to potential effects on human and animal health or the environment. Therefore the GMO Panel concludes that LLCotton25 is unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses.

[1] For citation purposes: Opinion of the Scientific Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-NL-2005-13) for the placing on the market of glufosinate-tolerant genetically modified LLCotton25, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience, The EFSA Journal (2006) 429, 1-19.

- Opinion adopted on 6 December 2006
- Table of Member States comments 

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