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Commercial Information Circulars
24-hour hotline : 23 922 922
e-mail address : enquiry@tid.gov.hk
Ref : EIC 111/2
11 February 2003
Dear Sirs,
Commercial Information Circular No. 52/2003
US : Proposed Regulations on Registration of Food Facilities and Prior Notice of Importation of Food
As foreshadowed in Commercial Information Circular No. 171/02 dated 26 August 2002, the Food and Drug Administration (FDA) of the US Department of Health and Human Services will issue proposed regulations requiring the registration of food facilities as well as prior notice of importation of food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. FDA has announced the proposed rules in the Federal Register notice of 3 February 2003, and is offering a 60-day comment period on the proposed rules. Interested parties may send their written comments by mail to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, US or by e-mail to http://www.fda.gov/dockets/ecomments before 4 April 2003. Highlights of the proposed rules are set out in the following paragraphs.
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Proposed Rule on Registration of Food Facilities
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Under the proposed rule, both US domestic and foreign facilities(1) that manufacture, process, pack, or hold food for human or animal consumption in the US would be required to register with FDA by 12 December 2003. Exemption will be given to foreign facilities if the food from such facilities undergoes further processing or packaging by another foreign facility before it is exported to the US. However, such exemption would not apply if the "further manufacturing/processing" at the subsequent facility is of a de minimis nature, such as affixing label to a package.
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Proposed Rule on Prior Notice of Importation of Food
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Under the proposed rule, with effect from 12 December 2003, prior notice must be submitted to FDA by noon of the calendar day before the day the imported food, whether or not intended for consumption in the US, will arrive at the US. The prior notice has to be submitted electronically through FDA Internet-based system which is now under development. The proposed regulation would not apply to food carried in an individual's personal baggage entering the US for personal consumption; and meat, poultry or egg products that are subject to the exclusive jurisdiction of the US Department of Agriculture at the time of importation.
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Due to bulkiness of the proposed rules, they are not appended to this circular for reference. Traders may obtain copy of the Federal Register notice by visiting (http://www.access.gpo.gov/su_docs/fedreg/a030203c.html) under Food and Drug Administration or visit FDA's web page on the Bioterrorism Act (http://www.fda.gov/oc/bioterrorism/bioact.html) for additional information.
ENQUIRIES
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For enquiries concerning the content of this circular, please contact the undersigned at 2398 5682.
Yours faithfully,
(Miss Sofie Chow)
for Director-General of Trade and Industry
(1) A foreign facility may designate its US agent as its agent in charge for purposes of registering the foreign facility.
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EDI Service for Restrained Textiles Export Licence (RTEL) enables traders to make RTEL applications directly through their office computer faster and easier. EDI Service is also provided for Production Notification and Certificate of Origin. For details and enquiries, please call Tradelink at 2599 1700. |
Note : While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same. |
