FDA Compliance Policy 7117.06镉溶出量(美国).docVIP

Sec. 545.400 Pottery (Ceramics); Imported and Domestic - Cadmium Contamination (CPG 7117.06) BACKGROUND: Imported and domestic ceramic ware has been found to have significant quantities of extractable cadmium. The metal is extractable by acid foods and could cause chronic cadmium poisoning under continued food use. REGULATORY ACTION GUIDANCE: The following criteria should be considered when deciding to recommend legal action or to detain imports to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605): The article: Is suitable to be used for liquid foods, and Contains upon examination of 6 units a level of cadmium per mL of leaching solution exceeding the guideline for the category specified as examined 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). Category Criteria Guidelines micrograms/mL Flatware Average of 6 units 0.5 Small Hollowware any one of 6 units 0.5 Large Hollowware any one of 6 units 0.25 The categories of ceramic articles, flatware and hollowware used in the preparation, serving or storage of food, are defined as follows: Flatware: ceramic articles which have an internal depth, as measured from the lowest point to the horizontal plane passing through the upper rim, that does not exceed 25 mm. Hollowware: ceramic articles having an internal depth, as measured from the lowest point to the horizontal plane passing through the upper rim, greater than 25 mm. Small hollowware: a capacity of less than 1.1 liter. Large hollowware: a capacity of 1.1 liter or more. NOTE: The article may be considered unsuitable for food use if: It is rendered unsuitable by some method such as boring holes through the potentia