![]() ![]() Intertek provides analyses of three lots of taurine that indicate that their product complies with these specifications. Intertek states that taurine meets the specifications in the Food Chemicals Codex (9th edition), including those for taurine purity (98.5 to 101.5%), lead (≤5 milligrams per kilogram (mg/kg)), and arsenic (≤2 mg/kg). The resulting taurine is purified, filtered, and crystallized. Taurine is synthesized from sodium bisulfite, ethylene oxide, ammonia, and sulfuric acid. Intertek describes the method of manufacture of taurine. Based on this review, Intertek’s GRAS panel concluded that taurine meeting its established food grade specifications is GRAS under the conditions of its intended use. Intertek’s GRAS panel evaluated the method of manufacture, product specifications, estimates of dietary exposure, as well as published and unpublished studies supporting the safety of taurine. Intertek considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. The notice informs FDA of the view of Intertek Scientific & Regulatory Consultancy (Intertek) that taurine is GRAS, through scientific procedures, for use as an ingredient in noncarbonated, flavored, water-based beverages at a level of 0.0045%.Īs part of its notice, Intertek includes the report of a panel of individuals (Intertek’s GRAS panel) that evaluated the data and information that are the basis for Intertek’s GRAS determination. Taurine is chemically identified as 2-aminoethanesulfonic acid. FDA received the notice on June 16, 2015, filed it on July 21, 2015, and designated it as GRAS Notice No. The Food and Drug Administration (FDA) is responding to the notice, dated May 13, 2015, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938 ApSubstances Generally Recognized as Safe (GRAS) the GRAS proposal). Intertek Scientific & Regulatory Consultancy See also Generally Recognized as Safe (GRAS). Return to inventory listing: GRAS Notice Inventory ![]()
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