Commercial Information Circulars
24-hour hotline : 23 922 922
e-mail address : enquiry@tid.gov.hk
Ref : EIC 111/2/19
10 July 2015
Dear Sirs,
Commercial Information Circular No. 644/2015
US : FDA's Final Determination Regarding Partially Hydrogenated Oils
The US Food and Drug Administration (FDA) announced in the Federal Register (FR) of 17 June 2015 the final determination that partially hydrogenated oils (PHOs), the primary dietary source of industrially-produced trans fat in processed foods, are not "generally recognised as safe" (GRAS) for use in human food. The compliance date of the order will be on 18 June 2018 and food manufacturers will have three years to remove PHOs from products. Relevant FR notice is available at http://www.gpo.gov/fdsys/pkg/FR-2015-06-17/pdf/2015-14883.pdf.
DETAILS
2.In 2013, FDA made a preliminary determination that PHOs were no longer GRAS. FDA is now finalizing that action and determining that PHOs are not GRAS for any use in human food. Major provisions of the order are summarised below:
- PHOs are not GRAS for any use in human food;
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Any interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s); and
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For the purpose of this declaratory order, FDA is defining PHOs as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4.
3.FDA has set a compliance period of three years. This will allow food manufacturers to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Following the compliance period, no PHOs can be added to human food unless they are otherwise approved by FDA.
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