The US FDA has issued a no objections letter (GRN 000763) to Agropur’s petition of GRAS status for alpha-lactalbumin protein as a food ingredient. Agropur’s ingredient, BiPRO® Alpha 9000, is a highly purified alpha-lactalbumin derived from bovine milk/whey with a protein content of at least 90% on solids basis. A high-quality protein with a complete amino acid profile, BiPRO® Alpha 9000 is lactose-free, fat-free and offers a clean, neutral flavor.
To be considered for GRAS status, Agropur submitted in-depth information about the product identity, specification, batch analyses, and the estimated dietary exposure of alpha-lactalbumin.
Alpha-lactalbumin can be used in several food categories, including those for which standards of identity exist. Agropur recommends its alpha-lactalbumin for protein-fortified beverages, nutritional bars including breakfast bars, snack bars, nutritional drinks and shakes, and powdered beverage mixes. Its high amount of tryptophan content makes alpha-lactalbumin suitable for special applications where the amino acid adds bio-functionality.
Mike Klein, Agropur’s VP Whey Ingredients Technical Services stated, “Our current customers for BiPRO® Alpha 9000 are primarily infant formula manufacturers. With the FDA GRAS status and with an expansion of our manufacturing capabilities, Agropur will be able to supply not only to infant formula manufacturers but also to special medical food formulators.”
The life sciences group, which is developing compounds to tackle obesity, high cholesterol, diabetes and skincare, said the license is contingent on an annual minimum order quantity and the first order within thirty days of signing the agreement