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US FDA Approved Genetically Engineered Salmon and Finalized GE and non-GE Labeling Guidance

Photo: Salmon
Photo: Salmon

On November 19, 2015, the United States Food and Drug Administration (US FDA) announced that they have approved genetically engineered (GE) salmon for human food [1], finalized their GE and non-GE labeling guidance for plants [2], and proposed their labeling guidance for GE and non-GE labeling for Atlantic Salmon [3].

Genetically Engineered Salmon

The US FDA has thoroughly analyzed and evaluated the data and information in regards to GE Atlantic salmon and has determined that it is safe to eat and as nutritious as other non-GE Atlantic salmon. The US FDA also determined that the DNA change that provides rapid growth is safe for the salmon.

The US FDA has stated that these fish may be raised only in land-based, contained hatchery tanks in two specific facilities located in Canada and Panama. These facilities and operations are designed to prevent any escape of eggs or fish from the facility, but if there is an escape the fish are reproductively sterile so would be unable to interbreed or establish populations in the wild.

Draft Guidance for GE and non-GE labeling of Atlantic Salmon

This draft guidance was published in the US federal register on November 24, 2015 and the public has 60 days to respond with comments. For food manufacturers that want to label non genetically engineered Atlantic salmon, or ingredients derived from such salmon, they may do so if the labeling is truthful and not misleading. The US FDA encourages use of statements such as “not bioengineered”, “not genetically engineered” or “not genetically modified through the use of modern biotechnology”. The US FDA does discourage the use of the phrase GMO as this refers to organisms, not food or food ingredients, but it will not take regulatory action providing the labeling is truthful and not misleading. Per the US FDA, a misleading statement would be any indication of unproven superiority of the non-GE product versus the GE product or the reverse.

For GE derived Atlantic salmon, the US FDA does not require specific labeling but if desired a phrase such as “genetically engineered” or “salmon patty made from Atlantic salmon produced using modern technology” can be placed on the label.

Labeling of Foods Derived from Genetically Engineered Plants

The US FDA once again reaffirmed that there is no requirement to label food or ingredients from genetically engineered plants providing there are no differences, beyond the specific genetic change, between the GE and non-GE plant product derived product or ingredient.

The US FDA position on labeling for GE or non-GE food or ingredients from plants is similar to that of the draft guidance for labeling of GE and non-GE for Atlantic salmon. Additional to the suggested truthful and not misleading GE or non-GE statements offered by the US FDA, they do discourage the use of the statements GMO free, GE free, does not contain GMOs, non-GMO and similar, because these statements convey zero or total absence and the potential challenge of substantiating these claims is both difficult and potentially misleading.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website. www.foodsafety.sgs.com.

Email SGS Hong Kong Ltd. at mktg.hk@sgs.com for enquiries or visit http://www.sgsgroup.com.hk/.


[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473249.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

[2] http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

[3] http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm469802.htm

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