EFSA adopts opinion on Bayer GM crop
genetically-modified cotton plant, which can be used for food
applications, presents no cause for concern.
EFSA's GMO panel has now adopted an opinion on the application for the commercialisation of glufosinate-tolerant genetically modified LLCotton25.
Developed by Bayer CropScience, the product is designed to provide tolerance to glufosinate-containing herbicides.
The issue of GM approval within the EU is one of the most contentious in agriculture. The recent announcement that US authorities had traced amounts of unapproved genetically modified (GM) food in samples of rice prompted the EU to clamp down on all imports from the US.
However, many biotech firms believe that the European market has a potentially lucrative future. The WTO ruled earlier this year that the EU and six member states had broken trade rules by barring entry to GM crops and foods.
In delivering its opinion, EFSA's GMO Panel considered additional information provided by 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.
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 panel also agreed that unintended environmental effects due to the establishment and spread of LLCotton25 will not be different from that of conventionally bred cotton.
The panel concluded by saying 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.
