FDA CPG 7117.05 镀银器皿—铅污染.docVIP

Sec. 545.500 Silver-Plated Hollowware - Lead Contamination (CPG 7117.05) BACKGROUND: Imported and domestic silver -plated hollowware have been found to contain significant quantities of leachable lead. The metal is extractable by acid foods and could cause chronic heavy metal poisoning under continued food use. REGULATORY ACTION GUIDANCE: The following represents criteria for detaining or recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605): IMPORTS: The article: (Unless exempted as defined below) is normally used to hold liquid or liquid type foods for storage or is used repeatedly to hold such foods;and If intended for use by adults, it releases in 6 units examined an average of seven or more micrograms lead/ml. of leaching solution.or If intended exclusively for use by infants and children, it releases in one or more of 6 units examined 0.5 or more micrograms lead/ml of leaching solution as determined by the current editions of ASTM method C738 (volume 15.02, Annual Book of ASTM Standards, American Society for Testing and Materials), AOAC methods 973.32 and 973.82 (Official Methods of Analysis, AOAC International), or FDA Laboratory Information Bulletin Numbers 4123 and 4126 (US Food and Drug Administration, *Division of Field* Science, HFC-140, Rockville, MD 20857). Liquid type foods include viscous foods some examples of which are applesauce, ketchup, gelatin and puddings, and solid foods in liquid medium some examples of which are peas, sauerkraut and fruits. NOTE: The article is not subject to the guideline if: It is made or rendered unsuitable for holding liquid or liquid type foods by some means such as bored holes; or It bears a label, incapable of obliteration, permanently affixed to the articles potential food contact surface; and such a label states that the article is not for food use along with a statement of the hazard associated with the article if used for food purposes. SPECIMEN CHARGE: