Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 111/2/19

20 October 2014

Dear Sirs,

Commercial Information Circular No. 914/2014

US : Registration of Food Facilities for Exports to the US

Food facilities required to register with the US Food and Drug Administration (FDA) must renew their food facility registrations this year during the period from 1 October 2014 to 31 December 2014.

DETAILS

2.The FDA Food Safety Modernization Act (FSMA), enacted on 4 January 2011, amended the food facility registration requirements of section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apply to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year.

3.For FDA has three guidance documents available to provide assistance to registrants with the registration process. These guidance documents are available at the following websites:

"The Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide" at
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm331957.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery;

"The Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registration" at
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm324778.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

ENQUIRIES

4.For enquiries concerning this circular, please contact Mr Lewis LAU at telephone number 2398 5405.

Yours faithfully,

(Miss Janice LAU)
for Director-General of Trade and Industry