FSMA - SCOPE

A. Food for Humans人類的食物		category	Food products/processes included	法規FDA regulations (As applicable, this is not an exhaustive list)
		食物種類	包括食品/製程	CFR21, Chapter I, Subchapter B,
	1	Low acid and Acidified foods [As applicable:LACF, AF, PCHF, Seafood HACCP, Juice HACCP]*低酸和酸化食物	a) Thermally processed low-acid foods packaged in hermetically sealed containers包裝在密封容器中熱處理的低酸食品	Part 108, 113, 117, 155, 172, 174
			b) Acidified foods 酸化食物	Part 108,114, 117, 172, 174
	2	Baby (Infant and Junior) Food Products Including Infant Formula Baby Food ([As applicable:PCHF, LACF, AF, Juice HACCP, Seafood HACCP]嬰兒（嬰幼兒）食品，包括嬰兒配方奶粉	a) Infant Formula requirements pertaining to current GMP, QC procedures, quality factors, records and reports, and notifications 嬰兒配方要求與當前的GMP，質量控製程序，質量因子，記錄和報告以及通知	Part 105, 106, 117, (108, 113, 114)
			b) Infant Formula: 嬰兒配方奶粉	Part 105, 107, 117
	3	Dairy products ([As applicable: PCHF, LACF, AF]*)乳製品	a) Milk and cream a）牛奶和奶油	Part 117, 131,172,174, (108, 113, 114)
			b) Cheeses and related cheese products b）奶酪和相關奶酪產品	Part 117, 133, 172,174, (108, 113, 114)
			c) Frozen desserts (except water ices)c）冷凍甜點（冰除外）	Part 117, 135, 172, 174
			d) Irradiation in the production, processing and handling of foodd）輻照生產，加工和處理的食品	Part 117, 172,174,179
	4	Dietary supplements and food for special dietary use膳食補充劑和特殊飲食食品	a) Foods for special Dietary Use	Part 105, 111, 117, 172, 174
			a）特殊膳食用食品
			b) Dietary supplements that present a significant or unreasonable risk/ b）存在顯著或不合理風險的膳食補充劑	Part 111, 117, 119, 172, 174
			c) Dietary supplements - new dietary ingredients c）新膳食成分的膳食補充劑 -	Part 111, 117, 190, 172, 174
			d) Irradiation in the production, processing and handling of food d）輻照食品的生產，加工和處理	Part 111, 117, 179, 172, 174
	5	Fisheries/Seafood products([As applicable:Seafood HACCP, LACF, AF]*)漁業/海鮮產品	a) Fish and Fishery products	Part 117, 121, 123, (108, 113, 114), 172, 174
			a）魚和漁產品
			b）魚類和貝類	Part 117, 121, 161,( 108, 113, 114), 172, 174
			b) Fish and shellfish
	6	Fresh produce or Fresh fruits and vegetable [As applicable, (Produce Safety; most fresh-cut produce under PCHF]*) 新鮮農產品或新鮮水果和蔬菜[適用時（生產安全;大部分鮮切產品）PCHF*）	a) Fresh Fruits新鮮水果	Part 112 (117, 172,174, 175, 178 for cut produce)
			b) Fresh vegetables 新鮮蔬菜	Part 112 ( 117, 172, 174, 175, 178 for cut produce)
	7	Processed Fruit and Fruit products[As applicable:PCHF, LACF, AF]*加工水果和水果產品	a) Canned fruits/a）水果罐頭	Part 117, 120, 145, (108, 113, 114), 172, 174
			b) Fruit pies/b）水果餡餅	Part 117, 120, 150, (108, 113, 114), 172, 174
			c) Fruit butters, jellies, preserves, and related products 水果黃油，果凍，蜜餞和相關產品	Part 117, 120, 152,(108, 113, 114), 172, 174
			d) Irradiation in the production, processing and handling of food輻照食品的生產，加工和處理	Part 117, 120, 172, 174, 179
	8	Fruit or Vegetable juices, other beverages including water[As applicable, PCHF, Juice HACCP, LACF, AF]* water水果或蔬菜汁，其他飲料，包括水	a) Canned fruit juices a）罐裝果汁	Part 117, 120, 146, (108, 113, 114), 172, 174.
			b) Vegetable juices b）蔬菜汁	Part 117, 156, (108, 113, 114), 172, 174
			c) Beverages c）飲料	Part 117, 129, (108, 113, 114), 172, 174
			d) Processing and bottling of bottled drinking water d）瓶裝飲用水的加工和裝瓶	Part 117,120, 129, 165, 172, 174
			e) Irradiation in the production, processing and handling of food食品生產，加工和處理中的輻照	Part 117, 120, 172,174, 179
	9	Vegetable and Vegetable products蔬菜和蔬菜產品	a) Canned vegetables a）蔬菜罐頭	Part 117, 155, (108, 113, 114), 172, 174
			b) Frozen vegetables b）冷凍蔬菜	Part 117, 158, 172, 174
			c) Irradiation in the production, processing and handling of food輻照食品的生產，加工和處理	Part 117, 179
	10	Shell Egg and egg products [As applicable, PCHF, LACF, AF]*殼蛋和蛋製品	a) Shell eggs a）殼蛋	Parts 115, 118, 160, 117, 65 FR 76092 (shell eggs), 179
			b) Eggs and egg products b）雞蛋和蛋製品
			c) Irradiation in the production, processing and handling of food
	11	Starch products [As applicable, PCHF, LACF, AF]*	a) Bakery products a）烘焙產品	Part 117 136, 172, 174
		澱粉產品	b) Cereal flours and related products b）穀物粉和相關產品	Part 117, 137, 172, 174, (113, 114, 108)
			c) Macaroni and noodle products	Part 117, 139, 172, 174
			c）通心粉和麵條產品
	12	Food Additives (Direct and Indirect) [As applicable: PCHF, Seafood HACCP, Juice HACCP, LACF, AF, Produce Safety]*食品添加劑（直接和間接）	a) Food additives a）食品添加劑	Part 117, 170
			b) Food additives permitted for direct addition to food for human consumption b）允許直接添加到食品中供人食用的食品添加劑	Part 117, 172
			c) Secondary direct food additives permitted in food for human consumption  c）允許食用的二級直接食品添加劑供人食用	Parts 117, 173
			d) Indirect food additives: General  d）間接食品添加劑：一般	Part 117, 174
			e) Indirect food additives: Adhesives and components of coatings  e）間接食品添加劑：塗料的粘合劑和組分	Part 117,175
			f) Indirect food additives: Paper and paperboard Components  f）間接食品添加劑：紙和紙板組件	Part 117, 176
			g) Indirect food additives: Polymers  g）間接食品添加劑：聚合物	Part 117, 177
			h) Indirect food additives: Adjuvants, production aids, and sanitizers  h）間接食品添加劑：佐劑，生產助劑和消毒劑	Part 117, 178
			i) Food additives permitted in food or in contact with food on an interim basis pending additional study  i）食品中允許的食品添加劑或臨時接觸食品的食品添加劑，等待進一步研究	Part 117, 180
			j) Sweeteners and table syrups j）甜味劑和糖漿	Part 117,168
			k) Food dressing and flavorings k）食品調味品和調味料	Part 117,169
			l) Irradiation in the production, processing and handling of food l）食品生產，加工和處理中的輻照	Part 117, 179
			m) Unavoidable contaminants in food for human consumption and food-packaging material m）食品中不可避免的污染物供人食用和食品包裝材料	Part 117, 109
	13	Nuts and Edible Seed Products[As applicable: Produce Safety; PCHF]*堅果和食用種子產品	a) Cacao products a）可可產品	Parts 112,117, 163, 172, 174
			b) Tree nut and peanut products b）樹堅果和花生製品	Part 112, 117, 164, 172, 174
	14	Food Ingredients and (food) substances[As applicable: PCHF, Seafood HACCP, Juice HACCP, LACF, AF, Produce Safety] *食品配料和（食品）物質	a) Prior-sanctioned food ingredients a）事先批准的食品成分	Part 117, 181
			b) Substances generally recognized as safe b）通常被認為是安全的物質	Part 117, 182
			c) Direct food substances affirmed as generally recognized as safe c）直接食品物質被確認為通常被認為是安全的	Part 117, 184
			d) Indirect food substances affirmed as generally recognized as safe d）確認間接食品物質被普遍認為是安全的	Part 117, 186
			e) Substances prohibited from use in human foods e）禁止在人類食品中使用的物質	Part 117, 189
			f) Irradiation in the production, processing and handling of food f）食品生產，加工和處理中的輻照	Part 117, 179
			g) Unavoidable contaminants in food for human consumption and food-packaging material	Part 117, 109
g）食品中不可避免的污染物供人食用和食品包裝材料
15	Fats and Oils[As applicable: PCHF, LACF, AF]*脂肪和油	Margarine	Parts 166, 110, 117, 108, 113, 114
		人造黃油
Type of food	B	Category Title :	Food products/processes included	Scopes mapped to FDA regulations (As applicable, this is not an exhaustive list)* CFR 21, Chapter I, Subchapter E
		Animal Food	B.動物食品類別
	I	Low Acid Canned Food[LACF + PCAF]* 低酸罐頭食品	a) Thermally processed low-acid foods packaged in hermetically sealed containers	Part 108, 113, 507, 509, 556, 570, 573, 579, 582, 584, 589.
			a）包裝在密封容器中熱處理的低酸食品
	II	Animal Food [LACF + PCAF]*動物食品	a) Animal food means food for animals other than man and includes pet food, animal feed, and raw materials and ingredients	Part 507, 509, 556, 570, 573, 579,  582, 584, 589
			a）動物食品是指除人以外的動物的食品，包括寵物食品，動物飼料，原料和配料
	III	Medicated Feed	(a) A medicated feed, in addition to providing nutrients, is a vehicle for the administration of a drug, or drugs, to animals. a）除了提供營養外，還是向動物施用藥物或藥物的加藥飼料。	Part 225, 507, 556, 509, 570, 573, 579, 582, 584, 589
		藥用飼料

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