[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.110]
[Page 229-230]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 110 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
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
[[Page 230]]
(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]
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