FDA Makes Available "Updated" Version of MOU on Daily-Use Ceramicware Imported from China
The Food and Drug Administration (FDA) has published in the Federal Register the text of an updated five-year Memorandum of Understanding (MOU) between the U.S. Food and Drug Administration (FDA) and China's Certification and Accreditation Administration (CNCA) regarding daily-use ceramicware manufactured in China and exported directly from China to the U.S. and intended for use in the preparation, serving, or storage of food.
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The FDA states that the continuing purpose of the U.S.-China MOU is to maintain a certification system that increases the likelihood that daily-use ceramicware manufactured in China and imported into the U.S. complies with U.S. law.
(The U.S. and China signed a five-year ceramicware MOU in 1999. The 1999 MOU replaced a similar one signed in 1988. See ITT's Online Archives or 08/06/99 news, 99080571, for BP summary on the signing of the 1999 MOU.
FDA sources state that the text of the updated 2006 MOU is identical to the 1999 MOU, with the exception of revisions that have been made in order to reflect certain Chinese government agency name changes.)
Certification of daily-use ceramicware factories. Under the terms of the MOU, CNCA directs China Entry-Exit Inspection and Quarantine Bureau (CIQ) to inspect Chinese factories that export daily-use ceramicware to the U.S. and certify only those whose ceramicware does not contain, or contains acceptably low levels of, lead and/or cadmium. CNCA is also required to provide FDA with a nationally standardized listing of factory names, addresses, and codes of CNCA/CIQ-certified daily-use ceramicware factories that export such daily-use ceramicware to the U.S.
China issues export certificates, but FDA does not require them. FDA sources note that although the MOU states that China will issue export certificates for daily-use ceramicware intended for export to the U.S., these certificates are not required by the FDA.
Sticker/logos with factory number affixed to each shipping and retail carton. Under the terms of the MOU, China will affix to each shipping carton and retail carton containing daily-use ceramicware that meets the CIQ "H" (for health) sticker/logo that is imprinted with the factory code of the CIQ-certified factory.
Each shipping carton must contain the factory or production lot number. China will also require that the factory lot or production lot number be on each shipping carton of the daily-use ceramicware to be exported to the U.S.
China to prevent, as practicable, export to U.S. of Chinese traditional ceramicware. The MOU provides that China will also prevent, to the extent practicable, the export to the U.S. of ceramicware which is not produced in a CNCA/CIQ-certified factory, such as Chinese traditional ceramicware (which has been found to leach unacceptable levels of lead).
FDA to adjust electronic entry system for ceramicware from CNCA/CIQ-identified/certified factories. Under the terms of the MOU, the FDA will adjust its electronic entry processing system and conduct surveillance monitoring of daily-use ceramicware from CNCA/CIQ-certified factories so that the "may proceed" rate can be higher for daily-use ceramicware firms identified/certified by CNCA/CIQ as consistently producing and exporting daily-use ceramicware in accordance with the MOU.
FDA to detain without physical exam lots from certified factories whose products appear to be violative. The MOU states that the FDA will detain, at its discretion, without physical examination, subsequent delivery lots of daily-use ceramicware from a CNCA/CIQ-certified factory whose products appear to be, through previous analysis, in violation of U.S. laws administered by FDA.
According to the MOU, the FDA will also promptly notify the Chinese government of any delivery lot or portion thereof of ceramicware covered by the MOU that is detained by FDA.
FDA contact - Matthew Eckel (301) 827-4480
Updated MOU (FR Pub 03/27/06) available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-2894.pdf.