(x)the primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein, and

(x)the primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein, and

Amino acid sequence homology comparison between the newly expressed protein and known allergens

Amino acid sequence homology comparison of the newly expressed protein and known allergens.

A positive sequence homology result indicates that the newly expressed protein has a high probability of being allergenic.

A positive sequence homology result indicates that the newly expressed protein is likely to be allergenic.

A repeated-dose 28-day oral toxicity study with the newly expressed protein in rodents.

the source of the introduced gene is considered allergenic, even if no sequence homology of the newly expressed protein to a known allergen is demonstrated; or

At present, there is no denitive test that can be relied upon to predict allergic response in humans to a newly expressed protein.

A comparison of the amino acid sequence of the newly expressed protein to amino acid sequences of known toxins to determine any potential homology.

At present there is no definitive test that can be relied upon to predict allergic response to a newly expressed protein.

At present there is no definitive test that can be relied upon to predict allergic response in humans to a newly expressed protein.

Data concerning the resistance of the newly expressed protein to proteolytic enzymes (such as pepsin), such as by in vitro investigations using appropriate and standardised tests.

Sequence homology searches comparing the structure of all newly expressed proteins with all known allergens should be done.

At present, there is no denitive test that can be relied upon to predict allergic response in humans to a newly expressed protein.