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阿原,江易原,記下一些事情跟朋友們分享,也留下自己學習與成長的紀錄。教學課程請見 "阿原小站" 還有阿原開放式課程阿原直播與教學影片阿原生活影片阿原創新顧問公司阿原科幻小說-NC1543、教師教學社團:開源軟體與教學應用
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2023/02/07

美國 FDA 法規中,可以免除實施 HARPC 的情況:PART 117 - CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

 

PART 117 - CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

§ 117.5 Exemptions.

   

(3) Subparts C and G of this part do not apply to on-farm packing or holding of food by a small or very small business, and § 117.201 does not apply to on-farm packing or holding of food by a very small business, if the only packing and holding activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts are the following low-risk packing or holding activity/food combinations - i.e., packing (or re-packing) (including weighing or conveying incidental to packing or re-packing); sorting, culling, or grading incidental to packing or storing; and storing (ambient, cold and controlled atmosphere) of:

(i) Baked goods (e.g., bread and cookies);

(ii) Candy (e.g., hard candy, fudge, maple candy, maple cream, nut brittles, taffy, and toffee);

(iii) Cocoa beans (roasted);

(iv) Cocoa products;

(v) Coffee beans (roasted);

(vi) Game meat jerky;

(vii) Gums, latexes, and resins that are processed foods;

(viii) Honey (pasteurized);

(ix) Jams, jellies, and preserves;

(x) Milled grain products (e.g., flour, bran, and corn meal);

(xi) Molasses and treacle;

(xii) Oils (e.g., olive oil and sunflower seed oil);

(xiii) Other fruit and vegetable products (e.g., flours made from legumes; pitted, dried fruits; sliced, dried apples; snack chips);

(xiv) Other grain products (e.g., dried pasta, oat flakes, and popcorn);

(xv) Other herb and spice products (e.g., chopped or ground dried herbs, herbal extracts);

(xvi) Peanut and tree nut products (e.g., roasted peanuts and tree nut flours);

(xvii) Processed seeds for direct consumption (e.g., roasted pumpkin seeds);

(xviii) Soft drinks and carbonated water;

(xix) Sugar;

(xx) Syrups (e.g., maple syrup and agave syrup);

(xxi) Trail mix and granola;

(xxii) Vinegar; and

(xxiii) Any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form). 

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簡單說:

1. 小型企業(定義請見 FDA)

2. 風險想對低的產品