§110.110 供人食用的食品中对健康无危害的、天然的、不可避免的缺陷(Natural or unavoidable defects in food for human use that present no health hazard)

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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.

　　（b） 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.

　　（d） 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.

　　（e） 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 供人食用的食品中对健康无危害的、天然的、不可避免的缺陷

　　a.有些食品，即使按照现行良好操作规范生产，但也可能带有天然的或不可避免的缺陷，这些缺陷在低水平时对人体健康无害。FDA为按照现行良好操作规范生产加工食品的缺陷制定了其上限标准，并用这些标准判断是否需要采取法律措施。

　　b.在必要和理由充分时，FDA将为食品制定缺陷行动水平。这些标准也是随着新技术的发展或新信息的获得而变化。

　　c.虽然食品符合缺陷行动水平，但不能以此作为借口而违反条例402（a）（4）节的规定，使食品不得在卫生不良的条件下生产加工、包装或存放，或本章提出的食品制造者、销售者及贮存者必须遵守现行的良好操作规范的要求。即使食品中天然的或不可避免的缺陷水平低于当前制定的缺陷行动水平时，如果事实证明确实存在违反上述要求的现象，那么，食品将成为条例所规定的劣质品。无论什么时候，食品制造者、销售者及贮存者都必须采用质量控制方法将天然的或不可避免的缺陷减少到最低限度。

　　d、不得将含有高于现行缺陷水平的食品与其他食品相混合，不管该混合食品的缺陷水平的高低，这些混合食品均被认为属于条例所规定的劣质品。

　　e、可向食品安全及应用营养中心的工业计划分部（HFS-565）去函索取人类食品中对健康无危害的、天然的或不可避免缺陷的现行水平标准汇编。

　　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