Home > Food Safety & Food Science Training > 21 C.F.R. Part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

21 C.F.R. PART 110 —


[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access [CITE: 21CFR110.3] [Page 223-224]

This material is from the FSIS/USDA website located here.

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§ 110.3


§ 110.5

Current good manufacturing practice

§ 110.10


§ 110.19


§ 110.20

Plant and grounds

§ 110.35

Sanitary operations

§ 110.37

Sanitary facilities and controls

§ 110.40

Equipment and utensils

§ 110.80

Processes and controls

§ 110.93

Warehousing and distribution

§ 110.110

Natural or unavoidable defects in food for human use that present no health hazard

Subpart G Defect Action Levels

Sec. 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

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(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]