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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

16 July 2004

Dear Sirs,

Commercial Information Circular No. 175/2004

USA : Prohibition of the Use of Certain Cattle Materials in Human Food and Cosmetics

The US Food and Drug Administration (FDA) published in the Federal Register (FR) notice of 14 July 2004 an interim final rule that prohibits the use of certain cattle materials in human food, including dietary supplements, and cosmetics with a view to minimizing the potential risk of human exposure to materials that may contain the agent that causes bovine spongiform encephalopathy (BSE, also known as mad cow disease). A proposed companion rule on the relevant recordkeeping requirements is also published in the FR notice.

 

Interim Final Rule

 

  1. Under the interim final rule, with immediate effect, the following prohibited cattle materials that carry a risk of transmitting BSE are not allowed in human food, including dietary supplements, and cosmetics -
    1. specified risk materials;
       
    2. small intestine of all cattle;
       
    3. material from non-ambulatory disabled cattle;
       
    4. material from cattle not inspected and passed for human consumption; and
       
    5. mechanically separated beef.

Prohibited cattle materials do not include tallow that contains no more than 0.15% hexane-insoluble impurities and tallow derivatives. Specified risk materials referred to in (i) above cover the brain, skull, eyes, trigeminal ganglia, spinal cords, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle.

  1. Manufacturers and processors who currently use prohibited cattle materials need to switch to alternative ingredients. The interim final rule also requires that manufacturers and processors make existing records relevant to compliance with the rule available to FDA for inspection and copying. This interim final rule takes effect immediately, but comments on it will be accepted within 90 days, i.e. until 12 October 2004.

Proposed Companion Rule on Recordkeeping Requirements

  1. In this connection, FDA is also seeking comments on a proposed rule which lays down the recordkeeping requirements for the above interim final rule. According to this proposal, manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, materials from cattle must establish and maintain records sufficient to demonstrate that the food or cosmetics is not manufactured from, processed with, or does not otherwise contain, the prohibited cattle materials as stipulated in the interim final rule. These records should generally contain a signed and dated affirmation (with contact information) from the slaughter establishment stating that cattle materials supplied do not contain the prohibited cattle materials. The record should be maintained at the manufacturing or processing establishment or at a reasonably accessible location for two years. For imported merchandise, importers would be required to electronically affirm their compliance with these recordkeeping requirements at the time the products enter the US and would have to provide the required records to FDA within a reasonable time, if requested. The comment period for the proposed rule will last for 30 days, i.e. until 13 August 2004.
     
  2. As the above-mentioned FR notices are quite bulky, interested parties may wish to download the information at:

 

 

Interim final rule -

 

http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-15881.pdf

 

Proposed companion rule on recordkeeping requirements -

 

http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-15880.pdf

Hardcopies are also available in the Americas (Commercial Relations) Branch of the Department for reference. Traders may also wish to visit the FDA website at http://www.fda.gov/oc/opacom/hottopics/bse.html for the relevant detailed information.

 

ENQUIRIES

 

  1. For enquiries concerning the content of this circular, please contact the undersigned at 2398 5682.




Yours faithfully,
 

(Miss Amanda Kwong)

for Director-General of Trade and Industry




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.