The Taiwan Food and Drug Administration (TFDA) has released a draft amendment to the official testing methods for the food additive Pyridoxine Hydrochloride (Vitamin B6) under the regulation titled “Food Additive Specification and Inspection Methods – Pyridoxine Hydrochloride (Vitamin B6).” The amendment aims to strengthen regulatory oversight and align analytical standards with current specifications established under Taiwan’s food additive regulations.
According to the draft explanatory note, the testing method for Pyridoxine Hydrochloride was originally established on September 10, 1991, and previously amended on October 25, 2013. The latest revision is proposed pursuant to Article 38 of the Food Safety and Sanitation Management Act, which authorizes the central competent authority to establish official testing methods for food, food additives, and related materials following consultation with the Food Testing Methods Advisory Committee.
The proposed amendments introduce technical revisions to several analytical parameters used to verify the quality and purity of Pyridoxine Hydrochloride. Specifically, updates have been made to the structural formula description, identification procedures, heavy metal testing method, loss on drying limits, residue on ignition test, and content determination procedures. These changes are intended to ensure that laboratory analysis of the additive remains accurate and consistent with the specifications set under the “Standards for the Scope, Application and Limitation of Food Additives.”
Under the revised specification, Pyridoxine Hydrochloride—defined by the molecular formula C?H??O?N·HCl and molecular weight 205.64—must maintain a purity level of not less than 98% on a dried basis. The compound is described as a white to pale yellow crystalline powder with no odor. The draft also retains key safety parameters, including a maximum heavy metal limit of 30 ppm (as lead), loss on drying not exceeding 0.5%, and residue on ignition not exceeding 0.1%.
Additionally, the amendment introduces a new reference section, citing authoritative sources such as the Japanese Food Additives Compendium issued by Japan’s Ministry of Health, Labour and Welfare. This inclusion is intended to enhance scientific traceability and support harmonization with internationally recognized analytical references.
Overall, the draft revision reflects Taiwan’s ongoing efforts to modernize analytical standards for food additives, improve testing clarity for laboratories, and ensure regulatory consistency in the monitoring of vitamin-based additives used in food products. Once finalized, the updated method will guide official testing procedures used by regulatory authorities and accredited laboratories when verifying compliance with food additive specifications.
Consumer News Region