Interpretive Materials on Four New Food Ingredients, Including Glucosyl Hesperidin
(1) Glucosyl hesperidin
Glucosyl hesperidin is produced from hesperidin derived from citrus fruits and dextrin, through enzymatic catalysis, purification, filtration, concentration, and drying. Hesperidin is a flavonoid naturally found in citrus fruits such as oranges and lemons. The main ingredient of this submitted product is α-glucosyl hesperidin (≥75%, on a dry basis), with a recommended daily intake of ≤500 mg (based on an α-glucosyl hesperidin content of 75 g per 100 g; for products exceeding this content, the actual content shall be used for calculation). Given the insufficient safety data on the consumption of glucosyl hesperidin in infants, pregnant women, and lactating women, and in accordance with the precautionary principle, these population groups are not advised to consume this product. Food safety indicators for this ingredient shall be in compliance with the relevant regulatory provisions. Glucosyl hesperidin is regulated in the United States as a “Generally Recognized As Safe” (GRAS) substance, and has been approved by the European Union as a novel food ingredient.
(2) Silk Fibroin
Silk fibroin is produced from white cocoons of the mulberry silkworm (Bombyx mori) through a series of processes, including degumming, water washing, salt solubilization, filtration, and drying. Its primary nutritional component is protein, with a content of ≥96.0 g per 100 g. The recommended daily intake for this product is ≤10 g, based on a protein content of 96 g per 100 g; for products with a higher protein content, the actual protein content shall be used for calculation. Given the insufficient safety data on the consumption of silk fibroin in infants, young children, pregnant women, and lactating women, and in accordance with the precautionary principle, these population groups are not advised to consume this product. Food safety standards for this ingredient shall be implemented in accordance with the relevant regulatory announcements. In the United States, silk fibroin is regulated as a “Generally Recognized as Safe” (GRAS) substance; in Canada, it is permitted for use as a food ingredient.
(3) Sodium γ-Polyglutamate
γ-Polyglutamic acid is a polypeptide formed by the amide linkage of D-glutamic acid and L-glutamic acid, naturally occurring in foods such as natto. Sodium γ-polyglutamate is produced from sodium glutamate, glucose, dipotassium hydrogen phosphate, manganese sulfate, and magnesium sulfate through fermentation using Bacillus subtilis XK-21, followed by membrane filtration, alcohol precipitation, and drying. The recommended daily intake for this product is ≤600 mg (based on a γ-polyglutamic acid content of 75 g per 100 g; for products with higher content, the actual content shall be used for calculation). Given the insufficient safety data on the consumption of sodium γ-polyglutamate in infants, young children, pregnant women, and lactating women, and in accordance with the precautionary principle, these population groups are not advised to consume this product. The food safety standards for this ingredient shall be implemented in accordance with the relevant regulatory announcements. In the United States, γ-polyglutamic acid is regulated as a “Generally Recognized As Safe” (GRAS) substance, while its potassium salt is classified as a novel dietary ingredient.
(4) L-Ergothioneine
L-ergothioneine is an amino acid derivative naturally present in edible mushrooms. The L-ergothioneine product submitted for approval is manufactured via microbial fermentation or chemical synthesis.
The microbial fermentation method uses glucose, yeast powder, and other raw materials, which are processed through fermentation by Rhodotorula or Escherichia coli, followed by crystallization and drying. The chemical synthesis method employs trimethylhistidine, cysteine, 3-mercapto propionic acid, and liquid bromine as raw materials, undergoing heating, separation, recrystallization, filtration, and drying. The product submitted for approval is L-ergothioneine with a content of ≥99.0 g/100 g, and the recommended daily intake is ≤20 mg (on a dry basis). Given the insufficient safety data on the consumption of L-ergothioneine in infants, pregnant women, and lactating women, and in accordance with the precautionary principle, these populations are not advised to consume this product. The food safety indicators for this ingredient shall be in compliance with the provisions set forth in the relevant announcements. In the United States, L-ergothioneine is regulated as a “Generally Recognized As Safe” (GRAS) substance; in the European Union, it has been approved as a novel food ingredient.