relative file path for layout
Skip to main content  Skip to search  Skip to main menu
Trade and Industry Department The Government of the Hong Kong Special Administrative Region
Brand Hong Kong - Asia world city
MY COLOUR

Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2/19

 5 October 2005

Dear Sirs,

Commercial Information Circular No. 408/2005

US : FDA Announced Final Rule on Registration of Food Facilities

Further to Commercial Information Circular (CIC) No. 97/2004 dated 16 April 2004, the US Food and Drug Administration (FDA) has recently issued a final rule implementing the food facilities registration provision under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act"). The relevant press release issued by FDA is at Annex A (pdf format)  and the Federal Register (FR) notice is at Annex B (pdf format)

  1. The final rule affirms the interim final rule on food facilities registration issued in October 2003 (please refer to CIC No. 258/2003 dated 14 October 2003). In sum, the rule requires that the owner, operator, or agent in charge of a domestic or foreign facility that manufactures/processes, packs, or holds food 1for human or animal consumption in the US, must register the facility with FDA. For registration purposes, foreign facilities must designate a US agent (for example, the facilities' importer or broker) who must live or maintain a place of business in the US and be physically present in the US. Failure to register may result in prosecution or import refusal.
  1. Traders are advised to visit FDA's website at http://www.fda.gov for the latest information about the implementation of the final rule.

ENQUIRIES

  1. For enquiries about the content of this circular, please contact Miss S Y TANG at telephone number 2398 5405.




Yours faithfully,


(Ms Charmaine LO)

for Director-General of Trade and Industry

1Examples of "food" include: dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), fruits and vegetables, fish and seafood, dairy products and shell eggs, raw agricultural commodities for use as food or components of food, canned and frozen foods, bakery goods, snack food, and candy (including chewing gum), live food animals, animal feeds and pet food etc..



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.