Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 111/2/19

6 May 2011

Dear Sirs,

Commercial Information Circular No. 267/2011

US : Information required in Prior Notice of Imported Food

The US Food and Drug Administration (FDA) issued in the Federal Register (FR) of 5 May 2011 an interim final rule to require an additional element of information in a prior notice of imported food, as required by the FDA Food Safety Modernization Act (FSMA). This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. This interim final rule will be effective as from 3 July 2011. Interested parties may submit comments to the FDA by 3 August 2011. The FR notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10955.pdf.

DETAILS

2.FDA's existing regulations on prior notice of imported food, as codified at Title 21, Code of Federal Regulations Part 1, Subpart I (21 CFR part 1, subpart I), were created after the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). The provisions of the Bioterrorism Act created the requirement that FDA receive certain information about imported foods before arrival in the US and that an article of food imported or offered for import is subject to refusal of admission into the US if adequate prior notice has not been provided to FDA. The regulations (21 CFR part 1, subpart I) are available at the FDA’s website at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1&showFR=1&subpartNode=21:1.0.1.1.1.7.

3.As foreshadowed in Commercial Information Circular No. 29/2011, the FSMA was enacted on 4 January 2011 to amend the FD&C Act with respect to the safety of the food supply in the US. As required in section 304 of the FSMA, the FDA would require additional information on “any country to which the article has been refused entry” be provided in a prior notice of imported food, including food for animals, in addition to other information already required. Please refer to the FR notice for details of the change.

4.For the latest information regarding the FSMA, traders are advised to visit the website of the FDA at http://www.fda.gov/Food/FoodSafety/FSMA/default.htm. Traders are also strongly advised to seek clarifications with their importers in the US in order to comply with the necessary requirements.

ENQUIRIES

5.For enquiries concerning this circular, please contact the undersigned at telephone number 2398 5682.

Yours faithfully,

(Miss Carmen CHAN)

for Director-General of Trade and Industry