我國健康食品製造良好作業規範之演進及變革   全文下載

The Evolution and Changes of Good Manufacturing Practice for health food in Taiwan

隨著時代演進及消費者越來越重視保健類食品之安全及製造品質，世界各國逐漸加深及加廣對保健食品製造管理之強度及面向，期望可更加提升保健食品之製造品質；我國之保健食品歸屬於一般食品管理，健康食品（Health food）則須經中央衛生主管機關依健康食品管理法規定查驗登記審查通過，核發健康食品許可證後，方得於產品標示或廣告健康食品保健功效之食品；依健康食品管理法規定，健康食品之製造應符合良好作業規範（Good manufacturing practice, GMP），故行政院衛生署（衛生福利部前身）自1999年公告訂定「健康食品工廠良好作業規範」後，我國中央及地方衛生主管機關即依該規範嚴密管理健康食品製造業者所產製之健康食品及其製造廠共歷經20餘年，後經衛生福利部考量「健康食品工廠良好作業規範」內容有與時俱進及變革之必要性，經審酌評估並參採國際間保健食品良好製造規範及調和我國食品製造管理相關規定後，於2023年發布訂定「健康食品製造良好作業規範標準」，並自2025年1月1日施行；本文將介紹我國最新健康食品造管理相關規定，並與原管理規定內容進行比較分析，希冀透過本文有助於健康食品製造業者及未來擬進入健康食品製造業之一般食品製造業者，提升其自主管理製造健康食品能力，使我國健康食品之製造管理邁向一新里程碑並接軌國際規範，以整體提升我國健康食品之國際競爭力。

With evolving time and increasing consumers focus on the safety and manufacturing quality of health supplements, countries around the world have gradually deepened and broadened the intensity and orientation of manufacturing management, in order to further improve the manufacturing quality of health supplements. In Taiwan, health supplements are initially managed as general food, and can only be labelled and advertised as health food with specific health claims after registering, reviewing, and obtaining health food permit by the central health authority in accordance with the provisions of the Health Food Control Act. According to the Act, Health food shall be manufactured in accordance with good manufacturing practices (GMP). Since the Department of Health, Executive Yuan (the predecessor of the Ministry of Health and Welfare) announced the“Good Manufacturing Practice for factories of Health food”in 1999, the central and local health authorities have strictly managed the health food manufacturers and their production facilities for more than 20 years in Taiwan. Considering the evolving needs to update and change for the content of the“Good Manufacturing Practice for factories of Health food,”the Ministry of Health and Welfare reviewed, evaluated, adopted and harmonized international good manufacturing practices of health supplements with relevant domestic regulations to release“The Standards of Good Manufacturing Practice for Health food”in 2023 and the regulation will come into effect on January 1, 2025. This article will introduce the latest relevant regulations of manufacturing management for health food in Taiwan, and conduct a comparative analysis with the original management regulations. Through comparative analysis, the aim is to help the manufacturers of health food, and manufacturers of general food planning to produce health food in the future to upgrade their self-management of health food manufacture. It also expects to bring the health food manufacturing management in Taiwan to a new milestone, and align with international standards to enhance global competitiveness of Taiwan’s health food industry.