Safety evaluation of certain food additives


Chemical and technical considerations



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Safety Evaluation Of Certain Food Additives 728850

1.2
Chemical and technical considerations
Branching glycosyltransferase is secreted during fermentation into the
fermentation broth and is subsequently purified and concentrated. The final product
is formulated with sorbitol, glycerol and water and standardized to a desired activity.
The total organic solids (TOS) content of the branching glycosyltransferase
preparation is approximately 4%. The branching glycosyltransferase enzyme
preparation complies with the General Specifications and Considerations for
Enzyme Preparations Used in Food Processing (FAO/WHO, 2006).
The branching glycosyltransferase preparation is intended for use in the
production of modified starch with improved functional properties, such as higher
solubility, lower viscosity and reduced retrogradation (undesirable structural
changes). The recommended use levels range from 0.4 to 40 kg of the enzyme
preparation per tonne of starch dry substance. The branching glycosyltransferase
is likely to be inactivated and/or removed during starch processing steps. The
enzyme is not added directly to food, and any carryover to food products formulated
with modified starch is expected to be very low.
2.
BIOLOGICAL DATA
2.1
Biochemical aspects
Branching glycosyltransferase has been evaluated for potential allergenicity
using bioinformatics criteria recommended in the report of the Joint Food and
Agriculture Organization of the United Nations (FAO)/World Health Organization
4
BRANCHING GLYCOSYLTRANSFERASE FROM RHODOTHERMUS OBAMENSIS


(WHO) Expert Consultation on Allergenicity of Foods Derived from Biotechnology
(FAO/WHO, 2001). An amino acid sequence homology search between
branching glycosyltransferase and known allergens listed in the allergen database
at 
http://fermi.utmb.edu/SDAP/index.html
was conducted. No homology was found
for sequence fragments of six contiguous amino acids. However, when using a
sliding window of 80 amino acids, a 35% match was found to sequences of Asp o
21 allergen, which is the 
Į-amylase from Aspergillus oryzae (TAKA amylase A).
However, the sequence alignment of the two enzymes showed that there are
large differences in the loop regions, and the overall identity is only about 32%.
As the two enzymes belong to the same family of glycosylhydrolases (Family 13;
http://www.cazy.org/fam/GH13_3D.html
), some homology is not surprising.
Although 
Į-amylase from A. oryzae is an occupational allergen (Skamstrup
Hansen et al., 1999), allergy symptoms after ingestion of the enzyme were reported
only for four individuals. Three of these individuals consumed bread baked with the
enzyme (Baur & Czuppon, 1995; Kanny & Moneret-Vautrin, 1995; Moreno-Ancillo
et al., 2004), and one had a positive response to the oral challenge with 
Į-amylase
(Losada et al., 1992). In other studies conducted with patients with documented
occupational or other allergies, no cases of food allergy to 
Į-amylase from A.
oryzae or other commercial enzymes used in food were identified (Skamstrup
Hansen et al., 1999; Bindslev-Jensen et al., 2006). Thus, food allergy to 
Į-amylase
from A. oryzae is extremely rare. Moreover, branching glycosyltransferase is a
bacterial protein, whereas nearly all known allergens listed in allergen databases
are eukaryotic proteins. Therefore, despite certain homology to 
Į-amylase from A.
oryzae, branching glycosyltransferase does not seem to have the characteristics of
a potential food allergen.

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