Detector De Metal
Updated: 2005-11-29
SECTION 555.425 -Foods - Adulteration Involving Hard or Sharp Foreign Objects
BACKGROUND:
Hardor sharp foreign objects in food may cause traumatic injury including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine as well as damage to the teeth andgums. From 1972 through 1997, the FDA Health Hazard Evaluation Board evaluated approximately 190 cases of hard or sharp foreign objects in food. These include cases of both injury and non-injuryreported to FDA. The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, andthe elderly. The scientific and clinical literature supports this conclusion.
Hard or sharp natural components of a food ( e.g. bones in seafood, shell in nut products) are unlikely to cause injurybecause of awareness on the part of the consumer that the component is a natural and intrinsic component of a particular product. The exception occurs when the food="s" label represents that the hardor sharp component has been removed from the food, e.g., pitted olives. The presence of the naturally occurring hard or sharp object in those situations (e.g., pit fragments in pitted olives) isunexpected and may cause injury. FDA has established Defect Action Levels for many of these types of unavoidable defects in other Compliance Policy Guides and therefore they are not subject to theguidance in this document.
REGULATORY ACTION GUIDANCE:
The following represent the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and directreference import detention to the districts.
a. The product contains a hard or sharp foreign object that measures 7 mm to 25 mm, in length.
and
b. The product is ready-to-eat, or according to...
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