Regulations on Good Hygiene Practice for Food Article 3

The terms used in these Regulations are defined as follows:1.Raw materials: Refers to food, food additives, food utensils, containers, packaging, or food cleansers, which constitute the ingredients and packaging materials of finished products.2.Ingredients: Refers to the constituent materials of finished products.3.Food workers: Refers to personnel whose duties involve direct contact with food or food additives, or who handle food or food additives using equipment and tools during processing, thereby affecting the hygiene and safety of the products.4.Operation site: Refers to the premises used for handling, manufacturing, processing, preparing, plating, packaging, and storing raw materials, semi-finished products, and finished products.5.Harmful microorganisms: Refers to microorganisms that cause food spoilage, quality deterioration, or pose a threat to public health.6.Contact surfaces:(1)Direct contact surface: Refers to the surface of utensils, containers, packaging, equipment, or facilities that come into direct contact with food or food additives.(2)Indirect contact surface: Equipment in processing or manufacturing operations where liquids or vapors that flow out come into direct contact with food or food additives.7.Separation: Refers to tangible or intangible isolation measures implemented in the operation sites based on factors such as location, time, or airflow direction.8.Food factory: Refers to food manufacturers subject to the Factory Management and Counseling Act.9.Vacuum-packaged ready-to-eat food: Refers to food that is vacuum-sealed in a hermetically sealed container and can be consumed immediately after opening .10.Heat sterilization: Refers to a heating process used to kill pathogens, spoilage organisms, and other microorganisms.11.Hermetically sealed container: Refers to a container that, once sealed, can prevent the intrusion of microorganisms.12.Commercial sterilization: Refers to a process using heat, chemical sterilants, or other methods to destroy viable microorganisms and their spores in vacuum-sealed packaged foods that are harmful to human health, ensuring that microorganisms harmless to human health cannot grow at room temperature.13.Low-acid foods in hermetically sealed containers processed by heat sterilization: Refers to foods with an equilibrium pH value greater than 4.6 and a water activity greater than 0.85, which undergo commercial sterilization before or after being packaged in hermetically sealed containers and are capable of being stored at room temperature.14.Acidified food: Refers to food to which acidulants or acidic ingredients are added, with a final pH value less than or equal to 4.6 and water activity greater than 0.85, which undergoes heat sterilization before or after being packaged in hermetically sealed container and can be stored at room temperature.
中文原文 食品良好衛生規範準則第3條
本準則用詞,定義如下:
一、原材料:指食品、食品添加物、食品器具、容器、包裝或食品用洗潔劑,其成品之原料及包裝材料。
二、原料:指成品之構成材料。
三、食品從業人員:指工作內容與食品、食品添加物直接接觸,或製程中用器械及工具處理食品、食品添加物,且影響產品衛生安全之人員。
四、作業場所:指原材料、半成品、成品之處理、製造、加工、調配、配膳、包裝及貯存之場所。
五、有害微生物:指造成食品腐敗、品質劣化或危害公共衛生之微生物。
六、接觸面:
(一)直接接觸面︰指食品或食品添加物直接接觸之器具、容器、包裝、設備或設施之表面。
(二)間接接觸面︰指加工或製造作業中,所流出之液體或蒸氣與食品、食品添加物直接接觸之設備。
七、區隔:指就作業場所,依場所、時間、空氣流向等條件,予以有形或無形隔離之措施。
八、食品工廠:指適用工廠管理輔導法之食品製造業者。
九、真空包裝即食食品:指脫氣密封於密閉容器內,拆封後即可食用之食品。
十、熱殺菌:指經加熱程序殺死病原菌、腐敗菌及其他微生物之措施。
十一、密閉容器:指密封後可防止微生物侵入之容器。
十二、商業滅菌:指利用熱、化學殺菌劑或其他方式,將密閉容器包裝食品中,對人體健康有害之活性微生物及其孢子殺滅,且於室溫下,對人體健康無害之微生物無法生長之措施。
十三、熱殺菌密閉容器包裝低酸性食品:指平衡之酸鹼值(以下稱pH值)大於四點六,及水活性大於零點八五,並於包裝至密閉容器前或後,施行商業滅菌,得於室溫下保存之食品。
十四、酸化食品:指添加酸化劑、酸性食品,且平衡pH值小於或等於四點六,及水活性大於零點八五,並於包裝至密閉容器前或後,施行熱殺菌,可於室溫下保存之食品。

English translation for reference only; the Chinese text prevails. Not legal advice.