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§ 110.110 Natural or unavoidable defects in food for human use that present no health hazard.
（a） Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The Food and Drug Administration establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action.
?。╞） Defect action levels are established for foods whenever it is necessary and feasible to do so. These levels are subject to change upon the development of new technology or the availability of new information.
（c） Compliance with defect action levels does not excuse violation of the requirement in section 402（a）（4） of the act that food not be prepared, packed, or held under unsanitary conditions or the requirements in this part that food manufacturers, distributors, and holders shall observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated within the meaning of the act, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of food shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.
?。╠） The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food.
?。╡） A compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition （HFS–565）, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
[51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
110.110 供人食用的食品中對(duì)健康無(wú)危害的、天然的、不可避免的缺陷
a.有些食品，即使按照現(xiàn)行良好操作規(guī)范生產(chǎn)，但也可能帶有天然的或不可避免的缺陷，這些缺陷在低水平時(shí)對(duì)人體健康無(wú)害。FDA為按照現(xiàn)行良好操作規(guī)范生產(chǎn)加工食品的缺陷制定了其上限標(biāo)準(zhǔn)，并用這些標(biāo)準(zhǔn)判斷是否需要采取法律措施。
b.在必要和理由充分時(shí)，F(xiàn)DA將為食品制定缺陷行動(dòng)水平。這些標(biāo)準(zhǔn)也是隨著新技術(shù)的發(fā)展或新信息的獲得而變化。
c.雖然食品符合缺陷行動(dòng)水平，但不能以此作為借口而違反條例402（a）（4）節(jié)的規(guī)定，使食品不得在衛(wèi)生不良的條件下生產(chǎn)加工、包裝或存放，或本章提出的食品制造者、銷售者及貯存者必須遵守現(xiàn)行的良好操作規(guī)范的要求。即使食品中天然的或不可避免的缺陷水平低于當(dāng)前制定的缺陷行動(dòng)水平時(shí)，如果事實(shí)證明確實(shí)存在違反上述要求的現(xiàn)象，那么，食品將成為條例所規(guī)定的劣質(zhì)品。無(wú)論什么時(shí)候，食品制造者、銷售者及貯存者都必須采用質(zhì)量控制方法將天然的或不可避免的缺陷減少到最低限度。
d、不得將含有高于現(xiàn)行缺陷水平的食品與其他食品相混合，不管該混合食品的缺陷水平的高低，這些混合食品均被認(rèn)為屬于條例所規(guī)定的劣質(zhì)品。
e、可向食品安全及應(yīng)用營(yíng)養(yǎng)中心的工業(yè)計(jì)劃分部（HFS-565）去函索取人類食品中對(duì)健康無(wú)危害的、天然的或不可避免缺陷的現(xiàn)行水平標(biāo)準(zhǔn)匯編。
更多關(guān)于美國(guó)FDA 21 CFR 第110部分的內(nèi)容，請(qǐng)?jiān)斠?jiàn)美國(guó)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
