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§ 110.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act （the act） are applicable to such terms when used in this part. The following definitions shall also apply:
?。╝） Acid foods or acidified foods means foods that have an equilibrium pH of 4.6 or below.
（b） Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice.
?。╟） Batter means a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.
?。╠） Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.
?。╡） Critical control point means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decomposition of the final food.
?。╢） Food means food as defined in section 201（f） of the act and includes raw materials and ingredients.
（g） Food-contact surfaces are those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. “Food-contact surfaces” includes utensils and food-contact surfaces of equipment.
?。╤） Lot means the food produced during a period of time indicated by a specific code.
?。╥） Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. The term “undesirable microorganisms” includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act. Occasionally in these regulations, FDA used the adjective “microbial” instead of using an adjectival phrase containing the word microorganism.
?。╦） Pest refers to any objectionable animals or insects including, but not limited to, birds, rodents, flies, and larvae.
?。╧） Plant means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food.
?。╨） Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the act.
?。╩） Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.
?。╪） Safe-moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity （aw）. An awwill be considered safe for a food if adequate data are available that demonstrate that the food at or below the given awwill not support the growth of undesirable microorganisms.
（o） Sanitize means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.
?。╬） Shall is used to state mandatory requirements.
?。╭） Should is used to state recommended or advisory procedures or identify recommended equipment.
（r） Water activity （aw） is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.
110.3 定義
聯(lián)邦食品、藥物及化妝品條例（以下簡稱條例）第201節(jié)中術(shù)語的定義和解釋適用于本部分的同類術(shù)語。下列定義亦同樣適用：
a.酸性食品或酸化食品：是指平衡pH值為4.6或低于4.6的食品。
b.適當(dāng)?shù)模褐笧檫_(dá)到良好的公共衛(wèi)生規(guī)范的預(yù)期目的所需要滿足的要求。
c.面糊：是指一種半流體物質(zhì)，通常包含面粉和其他輔料，食品的主要成分可浸在其中，或用它涂膜，或直接用來形成烘烤的食品。
d.熱燙：除堅果和花生外，指在包裝前對食品進(jìn)行足夠時間和充分溫度的熱處理，以使天然形成的酶部分地或完全失活，并使該食品產(chǎn)生物理或生化方面的變化。
e.關(guān)鍵控制點：是指食品加工過程中的一個點，在這個點上控制不當(dāng)時，就可能造成或?qū)е挛：?，或使成品受到雜質(zhì)污染，或造成成品的腐敗。
f.食品：指條例201（F）節(jié)所定義的食品。包括各種原料和輔料。
g.食品接觸面：指與人類食品的接觸表面以及在正常加工過程中因污水滴濺污染的并與食品接觸的設(shè)備和工器具表面。"食品接觸面"包括與食品接觸的工器具及設(shè)備的表面。
h.批：指在某一段時間生產(chǎn)的由具體代號標(biāo)記的食品。
i.微生物：是指酵母菌、霉菌、細(xì)菌和病毒，包括（但不僅限于）對公眾健康有影響的微生物種類。"有害微生物"這個術(shù)語包括對公眾健康有影響的，或使食品發(fā)酵分解的，或使食品受到雜質(zhì)污染的、或使食品成為條例所指的劣質(zhì)食品的微生物。有時，美國食品與藥物管理局在這些法規(guī)中使用"微生物"這個詞，而不使用包含"微生物"一詞的短語。
j.害蟲：指令人厭惡的任何動物或昆蟲，包括，但不僅限于鳥、嚙齒動物、蠅和幼蟲。
k.廠房：指用于人類食品加工、包裝、標(biāo)識或存放，或與人類食品的加工、包裝、標(biāo)識或存放有關(guān)的建筑物或設(shè)施或其中的某些部分。
l.質(zhì)量控制操作：是指一種有計劃的系統(tǒng)操作，并采取一切必要的行動防止食品成為條例所指的劣質(zhì)食品。
m.返工品：是指由于一些不衛(wèi)生因素而從加工過程中檢選出的、干凈的、未被摻雜的食品，或經(jīng)過重新加工而再次調(diào)制，并適于消費的食品。
n.安全水分含量：指在預(yù)期的加工、貯存和分銷條件下足以防止有害微生物生長的低水分含量。一種食品的最高安全水分含量取決于它的水分活度（aw），如果有足夠的數(shù)據(jù)證明，某一水分活度（aw）或低于食品水分活度（aw）時可以阻止有害微生物生長繁殖，那么就可以認(rèn)為這種食品的水分活度（aw）具有安全性。
o.消毒：是指用一種對食品接觸面進(jìn)行充分處理的方法，這種方法能有效地消滅危害公眾健康的微生物細(xì)胞，并大量減少其他有害微生物的數(shù)量。但消毒對食品的安全性不得產(chǎn)生不利的影響。
p.必須（ Shall）： 用于說明強(qiáng)制性的要求。
q.應(yīng)該（Should）：用于表述推薦性或建議性的程序或用以確定推薦性的設(shè)備。
r.水分活度（aw）：是食物中游離水分的量度，它是物質(zhì)的水蒸汽壓力與相同溫度下純水的蒸汽壓力的比率。
更多關(guān)于美國FDA 21 CFR 第110部分的內(nèi)容，請詳見美國FDA 21 CFR 第110部分關(guān)于食品生產(chǎn)企業(yè)現(xiàn)行良好操作規(guī)范（GMP）法規(guī)匯總
