May 22, 2012 | 3:51 pm

Cotton LL25

Summary of risk assessment

Opinion of the scientific panel on genetically modified organisms (GMO Panel) of the European Food Safety Authority (EFSA).
Adopted 06/12/2006
Conclusion LL25-Cotton is as safe as conventional cotton and therefore the placing on the market for processing and food and feed use is unlikely to cause adverse effects on human health and the environment.

 

Comparative study
Basis of comparsion LL25-Cotton from long-term field trials in the USA has been compared with conventional cotton. The variety Coker312 was selected as a comparison conventional plant (isogenic line).
Qualities of the plant Different parameters, such as cultivation properties, pollen production, plant development, outer characteristics, and susceptibility to pests and diseases were compared.
Compositional analysis Seeds and Cotton-Linters were compared. These short fibres consist mainly of Cellulose and are a raw material for food additives like Cellulose (E460) and Methycellulose (E461).

Different nutrients (fats, proteins, carbohydrates) as well as secondary elements, mineral elements and also amino acid and fatty acids were investigated:
There were no differences with the comparison conventional plants observed.

 

Safety of food and feed
New proteins
(PAT)		 14-day feeding study on rats: no indication of acute toxicity.

Comparison with known toxicologically questionable substances:
no correlation.

Allergenicity of new proteins No correlation was found with any known allergens (comparison of the amino acidsequences).

There have been no cases reported yet, in which there have been allergic reactions to cotton or to the newly introduced PAT-protein in the LL25-Cotton. Therefore, it seems improbable that LL25-Cotton could trigger allergies.

Trials in an artificial digestive tract showed that the new protein is not very stable and is rapidly decomposed.
Nutritional equivalence 33-day feeding trial on broiler chickens with a diet of LL25-Cottonseed:
No damaging effects were observed.

 

Enviromental safety
Survivebility Cotton originates from tropical regions. In its main production areas, it is improbable that cotton would establish itself outside of the cultivated fields.
Out-crossing Cotton (Gossypium hirsutum), is mainly self-pollinating. However, it is possible that the pollen may be spread by bees and bumble bees that visit the flowers. Thereby, out-crossings with other cultivated varieties may occur.

Cultivated cotton can cross-breed with certain related wild species (G. barbadense and G. tomentosum), which only are found in India, but not in other production areas.

The import and use of food and animal feed that have been produced from seed or linters of LL25-Cotton has been applied for, however, not the cultivation in the EU. Therefore, a deeper assessment of the environmental safety is not deemed as being necessary.

Field trails Field trails in the USA (2000; 2001) and in Australia and Brasil.