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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:
（a） 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.
（c） 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.
（d） 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.
（e） 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.
（f） 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.
（h） Lot means the food produced during a period of time indicated by a specific code.
（i） 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.
（j） Pest refers to any objectionable animals or insects including, but not limited to, birds, rodents, flies, and larvae.
（k） Plant means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food.
（l） 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.
（m） 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.
（n） 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.
（p） Shall is used to state mandatory requirements.
（q） 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 定义
联邦食品、药物及化妆品条例（以下简称条例）第201节中术语的定义和解释适用于本部分的同类术语。下列定义亦同样适用：
a.酸性食品或酸化食品：是指平衡pH值为4.6或低于4.6的食品。
b.适当的：指为达到良好的公共卫生规范的预期目的所需要满足的要求。
c.面糊：是指一种半流体物质，通常包含面粉和其他辅料，食品的主要成分可浸在其中，或用它涂膜，或直接用来形成烘烤的食品。
d.热烫：除坚果和花生外，指在包装前对食品进行足够时间和充分温度的热处理，以使天然形成的酶部分地或完全失活，并使该食品产生物理或生化方面的变化。
e.关键控制点：是指食品加工过程中的一个点，在这个点上控制不当时，就可能造成或导致危害，或使成品受到杂质污染，或造成成品的腐败。
f.食品：指条例201（F）节所定义的食品。包括各种原料和辅料。
g.食品接触面：指与人类食品的接触表面以及在正常加工过程中因污水滴溅污染的并与食品接触的设备和工器具表面。"食品接触面"包括与食品接触的工器具及设备的表面。
h.批：指在某一段时间生产的由具体代号标记的食品。
i.微生物：是指酵母菌、霉菌、细菌和病毒，包括（但不仅限于）对公众健康有影响的微生物种类。"有害微生物"这个术语包括对公众健康有影响的，或使食品发酵分解的，或使食品受到杂质污染的、或使食品成为条例所指的劣质食品的微生物。有时，美国食品与药物管理局在这些法规中使用"微生物"这个词，而不使用包含"微生物"一词的短语。
j.害虫：指令人厌恶的任何动物或昆虫，包括，但不仅限于鸟、啮齿动物、蝇和幼虫。
k.厂房：指用于人类食品加工、包装、标识或存放，或与人类食品的加工、包装、标识或存放有关的建筑物或设施或其中的某些部分。
l.质量控制操作：是指一种有计划的系统操作，并采取一切必要的行动防止食品成为条例所指的劣质食品。
m.返工品：是指由于一些不卫生因素而从加工过程中检选出的、干净的、未被掺杂的食品，或经过重新加工而再次调制，并适于消费的食品。
n.安全水分含量：指在预期的加工、贮存和分销条件下足以防止有害微生物生长的低水分含量。一种食品的最高安全水分含量取决于它的水分活度（aw），如果有足够的数据证明，某一水分活度（aw）或低于食品水分活度（aw）时可以阻止有害微生物生长繁殖，那么就可以认为这种食品的水分活度（aw）具有安全性。
o.消毒：是指用一种对食品接触面进行充分处理的方法，这种方法能有效地消灭危害公众健康的微生物细胞，并大量减少其他有害微生物的数量。但消毒对食品的安全性不得产生不利的影响。
p.必须（ Shall）： 用于说明强制性的要求。
q.应该（Should）：用于表述推荐性或建议性的程序或用以确定推荐性的设备。
r.水分活度（aw）：是食物中游离水分的量度，它是物质的水蒸汽压力与相同温度下纯水的蒸汽压力的比率。
更多关于美国FDA 21 CFR 第110部分的内容，请详见美国FDA 21 CFR 第110部分关于食品生产企业现行良好操作规范（GMP）法规汇总
